Full Time Jobs in Cambridge
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Senior Program Director - Bio Innovation Hub
Company: Novo Nordisk
Location: Cambridge
Posted Sep 25, 2023
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. Together, we're life changing. Novo Nordisk is an equal opportunity employer. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. Qualifications MS or MD, Degree within natural sciences is required, PhD and/or MBA strongly preferred 15+ years' relevant professional experience (if applicable, PhD time included): Project management experience leading cross-functional projects (prefer 5+ years in global projects); experience managing larger programs (not individual projects) is preferred Previous experience managing strategic alliances with demonstrated value creation is preferred Ability to run programs and projects independently and in close cooperation with colleagues across Novo Nordisk to ensure a holistic strategic solution to often multifaceted business problems As decisions involve coordination with other internal stakeholders in the HQ organization, affiliates, and external stakeholders, the ability to successfully navigate internal dynamics is required and experience working in a matrix organization preferred Demonstrated ability to present to, influence and build rapport with senior management Understanding the interface btw Legal, business development and alliance management Strong scientific and business understanding across R&D, and ideally experience from translational medicine / pre-clinical drug development Strong intercultural understanding and global collaboration capabilities both internally and externally High capacity for idea generation, hypothesis testing and problem solving, the ability to consolidate large amounts of complex information in a dynamic environment and to think outside the box to arrive at creative solutions Excellent collaboration, influential leadership skills and an ability to learn the Novo Nordisk business and organization, as well as the general pharma/biotech industry, is preferred Ability to motivate and influence others to advance goals, and the ability to effectively manage multiple projects or roles in a rapidly evolving environment Demonstrated ability to make strategic recommendations and manage risk with timely go/no-go decisions at all stages of the project/program delivery process Knowledge about different cultures, practices and procedures often required Demonstrates excellent verbal and written communication skills Proficient in Microsoft Office suite of products (Outlook, Excel, Word, PowerPoint) We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Ensure identification of best practices internally and externally and facilitate continuous improvement and innovation with the overall program, overall serving as a committed role model externally as well as internally Draw on and delegate into Line of Business and across Novo Nordisk SVP areas through multiple levels of employees and scientific experts to drive outcome, based on a clear sense of direction High independence and initiative should always be demonstrated when planning for, improving and performing tasks assigned by management In general, decisions are complex and involve coordination with other internal stakeholders in the HQ organization, affiliates, and external stakeholders for this position Assignments are characterized by high variability, complexity, and often by lack of precedence Actively connect and feed knowledge into the Global Novo Nordisk R&D organization, with a specific focus on diverse innovation approaches and lean project plan executions (early program and project de-risking), new ways of working, as well as asset transitioning Expected to actively challenge the ordinary processes and priorities upwards in the organizational hierarchy up to Executive Vice President level As the anchor of Quality, Improvement, and Knowledge sharing, this role requires the ability to identify better practices and create improvements in processes and approaches, as well as proactive action on quality and compliance-related matter Responsible for documentation and strategies required for regulatory submissions Ensure working in compliance with QMS, EHS and OHS standards Physical Requirements 0-10% overnight travel required. budget responsibility (15-70m USD) with the Bio Innovation Hub's strategic partners and collaborations, and manage and nurture existing business partnerships to maximize the value to Novo Nordisk Proactively engage with the core R&D organization to solve scientific challenges identified during product concept development and utilize the DK based Navigators to transfer assets, scientific challenges, and knowledge to the core research and early development organization Drive translational R&D plans for novel product concepts, actively engage with cross-functional Novo Nordisk R&D teams to execute on co-created R&D plans and ensure that decisions are guided by scientific and translational priorities, even when complex analysis of situations and data is required. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. The role will be the interface between the Bio Innovation Hub and the greater NN organization, including engaging with colleagues in Global Drug Discovery and Research Technologies, as well as the wider R&D organization across EVP/SVP areas. The holder of this role is responsible for managing a portfolio of projects that each require cross-functional teams operating across 2-3 companies, including biotech companies, venture capital firms, and academic institutions typically interacting at C-level in Joint Steering Committees.
Lead Specialist, Quality Assurance
Company: 2seventy bio
Location: Cambridge
Posted Sep 23, 2023
Perform daily operations within the eLMS, such as managing training items and curriculum, modifying user accounts, creating reports, and system troubleshooting. Lead, guide, and train staff/student employees, interns, and/or volunteers performing related work; may participate in the recruitment of volunteers, as appropriate to the area of operation. Select or develop training aids in collaboration with department management, including training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works. Work cross-functionally to formulate training outlines and determine instructional methods, utilize knowledge of specified training needs and effectiveness of such methods as individual training, group instruction, lectures, demonstrations, conferences, meetings, and workshops. Experience may be gained concurrently and must include:Three (3) years in each of the following:- Leading and facilitating trainings for individuals and departments- Preparing instructional aids and plans- Applying knowledge of GxP regulations, quality systems, and guidance documents including ICH- Managing all aspects of training including determining objectives, designing, developing, implementing, and evaluating training plans, curricula, and methodology.One (1) year in each of the following:- Working with Document Control- Utilizing ComplianceWire- Implementing and validating electronic systems for management of user training.2seventy bio has a mandatory vaccination policy for the COVID-19 vaccination for all employees, contractors and consultants as of January 4, 2022. May review instructor performance and recommend improvements to program content and/or instructor presentation methods; may recruit, select, and train instructors. Position reports into Cambridge, MA office; however, telecommuting from a home office may also be allowed.Requirements: Requires a Bachelor’s degree in Health Information Technology, Biotechnology, or a directly related scientific field plus three (3) years of experience organizing or conducting training in a GxP regulated industry. In accordance with 2seventy bios duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees, contractors, consultants and their families, and the community at large from infections disease that may be reduced by vaccinations. Coordinate Training eLMS administrative functions, including processes, logistics, delivery, metrics, and maintenance while identifying and effectively resolving quality issues or discrepancies. Deliver group and individual instruction and training covering a range of technical, operational, and/or management areas including new hire orientation.
Global Talent Management Specialist
Company: BeiGene
Location: Cambridge
Posted Sep 19, 2023
BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. All employment is decided on the basis of qualifications, merit, and business need. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. are continuously evolvingStrong proficiency in Microsoft Excel, Word, PowerPoint, Outlook, Teams and Zoom etc. )Work jointly with key stakeholders in Benefits, Equity, IT, Global Security, Legal & Compliance, Corporate Affairs, Quality, and Talent Development departments in order to enhance and support the new colleague experienceExecute reports within Workday HRIS system and partner with HR Operations team to ensure accuracy of new hire start dates, headcount and confidential hiresProvide support on all company surveys; engagement, pulse, exit and onboarding.Create and edit new hire corporate headshotsSupport updates and revisions of Global Talent Management reference guides, trainings and department tools and resourcesExemplify the desired culture and philosophies of BeiGeneMaintain a high degree of confidentiality and discretion on all matters, data and projects. Travel: 0-10%, Flexible schedule to accommodate global meetings Supervisory Responsibilities: NA BeiGene Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Evaluate effectiveness of current programs and provide input on continual improvementServe as key point of contact to the business for Talent Management initiatives and technology, addressing questions and requests in a timely and professional mannerServe as key point of contact for new hires across the Americas, enrich communication channels between new colleagues and other onboarding stakeholders and managementPrepare and execute all project management aspects of running onboarding orientations across Americas, EU and New Markets, including strategic scheduling, invitation distribution and response tracking, agenda and content development, post session follow-up, recording edits, survey administration and slide distributionPresent and host live meetings for new colleagues including interacting with both key presenters/executives and audience, as well as behind the scenes moderation (e.g., monitor chat, manage timing, run breakout rooms, record features, etc. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. As such, the selected applicant must be within commutable distance to either our Cambridge, MA, or San Mateo, CA, offices Qualifications: 1+ years of experience in HR related rolesFamiliarity with employee engagement and talent management programsStrong presentation and public speaking skills, both in person and virtual, with ability to gauge audience engagementStrong technical aptitude, skilled in navigating software and digital programsHighly adaptable and quick-learning professional, who thrives in dynamic environments, excels in navigating ambiguity, and embraces change with enthusiasm and initiativeStrong project management and organizational skills with demonstrated ability to work independently on multiple projects, navigating competing prioritiesProven ability to foster relationships at all levels of the organization, including C-SuiteAbility to collaborate with a team environment across various job functions, regions and time-zonesComfortable working in an environment in which businesses processes, tools, deadlines etc.
Scientist, Senior Scientist DMPK / Bioanalytical qPCR Focus
Company: Generation Bio
Location: Cambridge
Posted Sep 16, 2023
Help build the bioanalytical function and support early career colleagues· Employ cutting edge technologies to understand pharmacokinetics and tissue distribution of gene therapy products· Scientific oversight of CRO activities for outsourced studies including method transfer, data quality and analysis· Design experiments, analyze data & interpret results · Summarize studies in written reports and oral presentations REQUIREMENTS:· A PhD or a Masters with a minimum of 6 years experience in molecular biology, cell biology, or related discipline· Biotech and/or pharmaceutical industry experience is preferred· Experience in developing bioanalytical assays, excellent lab skills and ability to work independently to analyze, interpret, and present data· Ability to support multiple projects across platform · Ability to work in a matrixed environment · Experience with cell lines, primary hepatocytes, a plus· Organized, excellent communication skills, collaborative, team player mindset POSITION: Full-Time, ExemptEEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. Significant cross functional interactions are required with key partnerships between Pharmacology, Toxicology, Formulation and other departments.RESPONSIBILITIES:· Design, optimize, and execute assays to assess drug concentration from in vitro and in vivo samples, in various biological matrices via qPCR and/or other molecular techniques. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race (to include traits historically associated with race including, but not limited to, hair texture, hair type, hair length, and protective hairstyles such as braids, locks, twists, hair coverings, and Bantu knots), color, gender, religion, national origin, gender identity, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. The job responsibilities also include working closely with CRO’s to transfer assays, providing scientific oversight for externally sourced studies, and ensuring seamless execution in collaboration with our Operations team. to support in vivo studies 2) routine analysis of in vitro and in vivo samples with appropriate methods and the generation of study reports 3) leading novel assay development projects 4) collaborating with cross-functional teams and 5) mentoring of junior team members. This is a significant learning opportunity and the candidate is expected to be an independent thinker, a self-starter, and someone who is not afraid to push the boundaries of science. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.We are a thriving, collaborative, creative community of 165 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts. Delve further. Please visit www.generationbio.com or follow @generationbio. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. To see additional roles, please also check out https://generationbio.com/careers/ Generation Bio is seeking a highly motivated, energetic, and enthusiastic scientist to join our rapidly growing DMPK/bioanalytical team to support preclinical and early clinical development phases of non-viral vector-based gene therapies. The primary job responsibilities include: 1) developing bioanalytical methods using molecular assays such as: (RT)-qPCR, ddPCR, NGS etc. We are seeking an exceptional individual to fill this critical role in our organization where you will be part of a versatile, fast-paced, and collaborative team.
Executive Assistant, Legal & Compliance
Company: Amylyx
Location: Cambridge
Posted Oct 06, 2023
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Support the Chief Legal Officer & General Counsel in preparing agendas, collecting and reviewing presentation materials, reserving conference rooms and coordinating video conferences (MS Teams, Zoom, etc. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. including opening and closing POs, processing invoices, onboarding new vendors, managing vendor offboarding process.Partner with other Executive Assistants to organize corporate events and meetings and Extended Leadership Team meetings. Work with Legal/Compliance functional leaders to build annual budget, ensuring new line items are assigned to appropriate budget code; track and review quarterly forecast.Support the Legal/Compliance team with the management of POs, invoices, etc. ).Make recommendations for new ways of managing workflows and process improvements as needed.Develop collaborative relationships with the Executive Assistant to the Co-CEOs, the Executive Assistant to the CFO, the Executive Assistant to the CCO, and the Executive Assistant to the CHRO providing back-up support as needed.Coordinate domestic and international travel as well as process travel & expense reports for reimbursement.REQUIREMENTS8+ years of experience supporting C-Level executives.Bachelor’s Degree and Legal experience a plus but not required.Excellent organizational and prioritization abilities with meticulous attention to detail.Strong interpersonal and communication skills with the ability to build and nurture relationships with stakeholders, including employees at all levels, executives, and board members.Incredibly proactive; able to anticipate needs and prioritize day to day work and projects based on the demands of the business.Anticipate and resolve issues.Proven time management skills with the ability to handle multiple tasks, execute effectively against multiple projects and deadlines, and remain cool under pressure.Demonstrated ability to operate independently, use sound judgement and professionalism.Applies confidentiality and accuracy to work and interactions with employees and external partners.Demonstrated proactive approaches to problem-solving,Resourceful team-player, with the ability to also be extremely effective independently.Highly proficient in Microsoft Office Suite and an ability to learn additional project management and collaboration tools.Contracts Management Systems experience preferred.Able to work cross-functionally in a matrix environment.Years of experience and educationTo stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. Provide support in the preparation of executive and Board of Directors materials, helping to iterate presentations, reviewing documents for content flow and accuracy.Support the Chief Legal Officer & General Counsel in preparations for monthly Board meetings, ensuring meeting materials are received on time, providing presenters with guidance on effective presentations, coordinating with the Executive Assistant to Co-CEO’s to understand potential conflicts.Support other members of the Legal & Compliance department for various administrative needs across the function, including but not limited to supporting the Global Compliance Officer in implementation of the compliance program, Intellectual Property docket management, tracking state licensures, issuing and tracking litigation holds, and supporting implementation and upkeep of a contract management system.Manage Legal & Compliance budget, tracking budgeted and unbudgeted spend against Purchase Orders (PO) and invoices, and providing awareness on actual to budget. Must be a team player, responsive and able to function independently, manage highly confidential and sensitive information and matters with the utmost discretion.The person in this role will have exceptional written and verbal communication skills, with the ability to create and edit communications, meeting notes when required, meeting preparation materials, and presentations, ensuring accuracy, attention to detail, and follow through. This position offers a unique opportunity to be part of a highly respected Legal & Compliance team and support a key leader in the organization.RESPONSIBILITIESWork closely and effectively with the Chief Legal Officer & General Counsel, providing support in organizing meetings and calendar management, prioritizing appropriately.Draft and/or edit materials including documents, PowerPoint presentations, and reports. In this visible role, the Executive Assistant, Legal & Compliance is responsible for proactively listening, anticipating and meeting priorities in a fast-paced environment.
Archive-Submittals Coordinator
Company: SMMA
Location: Cambridge
Posted Sep 22, 2023
We are guided by a shared pursuit of design excellence, sustainability, and social responsibility. Company Perks Employee-owned firm with Employee Stock Ownership Program Hybrid work-from-home policy Competitive benefits including paid time-off, company-funded MA Paid Family and Medical Leave, company-paid dental plan, company-paid life insurance, and 401(K) matching Employee Assistance Program (includes confidential emotional support, legal guidance, and financial resources) Mentor/protégé program Educational reimbursement Licensure and membership reimbursement “Lunch and Learns” with internal and external speakers Today, we remain dedicated to this flexible, integrated approach. Our work straddles seven markets—K-12, Higher Education, Corporate, Commercial, Life Science, Federal Government, and Advanced Technology—with the opportunity to work across a wide range of projects and specialisms. Cambridge-based since our incorporation in 1955, we offer an integrated, multidisciplinary environment driven by collaboration between architects, interior designers, engineers, technologists, researchers, and industry experts. We offer a fast-paced, team-oriented environment that promotes intellectual and creative growth. SMMA was founded by MIT and Rensselaer alumni who believed that the balance of architecture, engineering, interiors, and site design afforded clients the agility of a single source of creative and technical expertise. Key Archive Responsibilities Assist with digital asset management, records management, and project close-out activities Organize and inventory drawings and project documentation Preserve and rehouse archival material in various formats Assist with the preparation of archival materials for transfer to off-site storage and clients Key Submittals Responsibilities Process and track shop drawings and samples with respective trades (Ex: architectural, structural, MEP, specialist consultants) Coordinate with respective trades, contractors, and consultants during construction phase Prepare shop drawing status reports Respond to technical and coordination issues related to tracking of shop drawings Set up QC reviews and coordinate with project managers, consultants, and clients Secondary Responsibilities As needed additional support for administrative team members to cover vacations and absences. Print Room services: Printing, coordinate delivery services, travel arrangements, and mail distribution Administrative services: catering requests, meeting arrangements, and occasional reception coverage Key Competencies Proficient with Bluebeam, Acrobat, and MS Office including Word, Excel, Teams, and Outlook Ability to work in a team environment and on an individual basis Ability to communicate both verbally and in writing Good interpersonal skills and attention to detail Ability to work well under pressure Well-organized and flexible, with the ability to prioritize tasks in a fast-paced environment Strong organizational, interpersonal, and communication skills Minimum Qualifications Current college student actively pursuing a degree in Architecture, Engineering, or Interior Design Technical knowledge of the AE industry or experience as a librarian Two years of general office experience Ability to lift and carry boxes weighing up to 40 pounds and move furniture Ability to stand, stoop, bend, and work in tight spaces About the Firm SMMA is one of New England’s most unique design firms due to our composition, reputation, and focus. We focus on building lasting relationships with strategic partners in both the public and private markets. As an employee-owned firm, we believe that good ideas are welcome from anywhere. The primary responsibility of the Archive/Submittals Coordinator will be to maintain control over project archives and shop drawings through a computerized database and to ensure proper filing, storage, and retrieval of documents. The secondary responsibility will be to provide print room and administrative support. SMMA is seeking an Archive/Submittals Coordinator to handle project document archiving maintaining control over a computerized database of historic project information, and to manage project submissions and approve shop drawings and samples from consultants.
Senior Product Designer
Company: Insurify
Location: Cambridge
Posted Sep 19, 2023
You enjoy using data and research to form hypotheses and craft unique, testable product experiences that help drive business impact.Create clear, intuitive, and visually appealing human interfaces.Care about business needs, implications, and practicality of your designs. Our company vision is to be recognized as the preeminent and most trusted digital agent for insurance comparison, purchase, and management. Our team is critical to achieving our vision and fostering the right culture is essential to our team’s success.Join us if you like$1.3 Trillion market opportunityMIT alumni foundersFemale-led startup$130M total fundingStrong leadership team from Kayak, Amazon, Wayfair, Facebook, Microsoft, Allstate, GEICO, Liberty Mutual, ZillowHow you will make an impactCollaborate with Product Management partners to plan, execute, and analyze A/B tests and other experiments to evaluate the effectiveness of design changes and inform iterative improvements.Design product concepts that balance vision, craft, speed, and business potential.Craft every detail of new product features, from idea to UX to pixel-perfect execution.Create new patterns that are intuitive, practical, and convergent. You don't get stuck on pretty UI or deep abstractions and can balance between craft, speed, and the bottom line.BenefitsCompetitive compensationGenerous stock optionsHealth, Dental Coverages401K plan with matchUnlimited PTOGenerous company holiday calendarLearning & Development StipendsPaid Family LeaveSocial impact volunteer time and donation matchesCatered lunches in the officeFree snacks and beverages every day in officeLI-HybridWe are proud to be an Equal Employment Opportunity and Affirmative Action employer. We’re changing the way millions of people compare, buy and manage insurance with artificial intelligence, technology, and superior product design. Evolve our design system intentionally as we scale.Stay current with industry trends, design best practices, to continually enhance the design process.Who you are5+ years of experience working on/with growth teams and thriving in a fast-paced environment.Strong portfolio showcasing your ability to drive user engagement and conversion through design solutions and think strategically and creatively, balancing business goals with user needs.Curious and passionate about learning and experimentation. Why us? Insurify is one of the America’s fastest-growing MIT FinTech startups and has been recognized as one of Inc. 5,000’s fastest-growing private companies in America of 2023, 2022 and 2021, Forbes Fintech 50 List for 2023, 22, 21, Forbes Next Billion Dollar Startups of 2022 global and Top 100 InsurTech company.
Digital Public Relations Associate
Company: Insurify
Location: Cambridge
Posted Oct 11, 2023
We’re changing the way millions of people compare and buy insurance with artificial intelligence, technology, and superior product design.Our team is highly analytical, fast-moving, and focused on one thing: getting more people to compare insurance quotes using Insurify.Join us if you like: $1.3 Trillion market opportunityMIT alumni foundersFemale-led startup$130M total fundingStrong leadership team from Kayak, Amazon, Wayfair, Facebook, Microsoft, Allstate, GEICO, Liberty Mutual, ZillowHow you will make an impact:Support audience growth goals through earning references, citations and backlinks to Insurify in key digital media outletsCurate media and contact lists for our key target audience cohorts, including key media outlets such as major publications, national and regional news media, affiliates & direct partnersBuild and nurture relationships with journalists and editors at these key media outlets, understanding their interests and how our data, content, studies and reports can resonate with them and their audiencesRegularly review successes and opportunities for improvements to build an experimentation program designed to test, learn, and optimize all input processes that drive towards our outreach and audience growth goals Work to keep on top of key media trends and breaking newsPlay a key role in creating a proactive content strategy that drives media attention and builds authorityAnalyze competitor content and successes to identify opportunities for improvement Contribute to the digital PR strategy for topics including auto and homeownership in relation to insurance Work up to owning outreach campaigns from ideation of data content to pitchingWho you are:A self-starter who is comfortable using data in storytelling You have 1-3 years of writing, data analysis or digital PR experience You already understand or are interested in how links make an impact on SEOYou are excited about brainstorming and shipping new data-driven content ideasYou are always looking for incremental ways to improve whatever you are working onYou love writing and have strong communication skills You are an analytical person who dives deep to understand the “why” behind questionsYou are a detailed-oriented person who takes time to understand what will engage your audience Benefits:Competitive compensationGenerous stock optionsHealth, Dental Coverages401K plan with matchUnlimited PTOGenerous company holiday calendarLearning & Development StipendsPaid Family LeaveSocial impact volunteer time and donation matchesCatered lunches in the officeWe are proud to be an Equal Employment Opportunity and Affirmative Action employer. Do you want to be part of Boston’s hottest up and coming startup? Insurify is one of the fastest-growing MIT FinTech startups and has been recognized as a global Top 100 InsurTech company.
Senior Associate Scientist / Principal Associate Scientist – Upstream Process Development
Company: Generation Bio
Location: Cambridge
Posted Oct 05, 2023
We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race (to include traits historically associated with race including, but not limited to, hair texture, hair type, hair length, and protective hairstyles such as braids, locks, twists, hair coverings, and Bantu knots), color, gender, religion, national origin, gender identity, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. This role will have high visibility in a company that is expanding to support a dynamic pipeline.RESPONSIBILITIES:Primary responsibilities for this role include:Design, execute and analyze process development and characterization experiments for enzyme-based production of DNA-based drug substanceDocument experimental execution and analysis via electronic lab notebookEstablish scale-down process models and perform process characterization utilizing DOE principlesSupport development and optimization of RES ceDNA production and process methodologies for lead candidate and subsequent platform programs.Create and edit documentation including protocols, SOPS, batch records, reports.Identify and/or optimize unit operations to improve robustness, cycle time, throughput, and cost while maintaining product qualitySupport the development and optimization of the lead candidate through process innovation, and identification of key variables to improve process performancePrepare, analyze, and present data internally to cross functional teamsQUALIFICATIONS: Degree in Molecular Biology, Bioengineering, Cell Biology or related disciplineMinimum of 2 years of relevant industry experienceExperience in developing processes for synthesizing biologics, enzymatic reactions, and/or purification of complex biomoleculesUnderstanding and practical application of molecular biology techniquesSense of urgency, results-driven, and excellent attention to detailProven ability to work independently, effectively plan work activities, and prioritize task completion to meet schedules and deadlinesStrong collaboration and team-working skillsDesired experience:Knowledge of cGMP and regulatory guidelines and practices, and how these relate to and impact upstream developmentTrack record of managing multiple projects and responsibilities simultaneouslyExperience with high throughput screening technologies and developing enzyme activity assaysPOSITION: Full-Time, Non-ExemptEEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.We are a thriving, collaborative, creative community of 165 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts. Delve further. Please visit www.generationbio.com or follow @generationbio. To see additional roles, please also check out https://generationbio.com/careers/ SUMMARYGeneration Bio seeks an enthusiastic and highly motivated Senior/Principal Associate Scientist to guide Drug Substance Upstream Process development as part of the Chemistry, Manufacturing and Control (CMC) department. The Upstream Process Development team is focused on creating, optimizing and understanding the control strategy for our GMP compliant process. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. The company’s non-viral platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses its proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The successful candidate will have good laboratory skills and attention to detail to help develop and optimize enzyme-based production processes for DNA-based drug substance. Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases.
Vesalius : Head of Data Science
Company: Vesalius Therapeutics
Location: Cambridge
Posted Oct 13, 2023
We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. Experience comes in many forms, skills are transferable, and passion goes a long way. Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture. Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. You can read more about our mission here. About FlagshipFlagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Outstanding quantitative skills and demonstrated statistical intuition.&8239; A strong record of accomplishment in the field, including publications, patents, and presentations.&8239; Direct supervisory experience (5+ years) leading a team of scientists (including PhD-level scientists) and a track record of recruiting, mentoring, and developing top talent.&8239; Outstanding communication, collaboration, networking, and program leadership skills.&8239; Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. Demonstrated ability to work in a dynamic environment with a sense of urgency and creativity and focus on deliverables.Team player with a strong work ethic, able to work both independently and collaboratively Continuously learns and adapts quickly to new informationAuthentic, proactively appreciative of different points of view, backgrounds and perspectivesWhat We’ll Offer You: Comprehensive, competitive healthcare (PPO) and dental coverage through Blue Cross Blue Shield, vision coverage through VSP, family leave, three weeks’ paid time off with additional holidays, 401k retirement plan, disability and life insurance, and commuter benefits. A dynamic early-stage work environment and highly interdisciplinary, talented, and collaborative team. Participate in the development and growth of a company with enormous potential impact on human healthProfessional growth opportunities through mentoring, training, immersion in cross-functional projects, and opportunities to learn and try new things. Who We Are: Vesalius Therapeutics is a Flagship Pioneering platform company with a bold and critical mission to revolutionize drug development for the diseases that cause 90% of global morbidity and mortality. The company was founded in 2019 in Flagship Labs, Flagship Pioneering’s innovation foundry. Vesalius is led by CEO Christopher Austin, M.D., Flagship Managing Partner, Doug Cole, M.D., and a leadership team with decades of experience working at some of the most renowned pharma and biotech companies in the industry. Vesalius’s ContinuumDiscovery™ platform harnesses a combination of human clinical data and genetics, artificial intelligence and machine learning, and patient-derived experimental models into a uniquely potent discovery engine. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Learn more about Flagship at www.flagshippioneering.com.At Flagship, we recognize there is no perfect candidate. Strong track record of method development and implementation, innovative and creative question posing and solution. Where appropriate, develop and implement new statistical methods to achieve key goals.&8239; Roll out an experimental design and statistical testing framework across functions&8239; Be a strong voice in the development and implementation of our target discovery platform&8239; Assemble and lead a team of skilled scientists to execute this mission, and collaborate across our diverse group of scientific disciplines to develop new ideas&8239; Requirements PhD in statistical genetics, computational biology or equivalent field, and 8-10 years of relevant experience in an industry or academic setting.
Contract - Office Manager & Receptionist
Company: Vedanta Biosciences
Location: Cambridge
Posted Sep 20, 2023
Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.Our Vision:We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortiaVedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. The right candidate will be organized, proactive, flexible, and collaborative. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. There is no flexibility to work from home.Proficient in current technology used in the workplace: MS Outlook, including Teams and Zoom, file-sharing platforms, and smartphones.Must be comfortable operating in a casual and dynamic environment that requires flexibility, on-demand service, thinking on your feet, and independent decision-making.Must be able to lift and carry packages weighing up to 25 lbs. They must be friendly and enjoy frequent, recurrent, and unplanned communication both in-person, on the phone, and via email.Here’s What You’ll Do:Reception:Manage main phone line and visitors, incoming and outgoing mail.Act as point person for many and various questions from team members and visitors.Develop a sufficient understanding of the business operations of Vedanta so this individual can direct questions/requests to the appropriate group.Must be comfortable acting as a “hub” of information.Place business card orders.Office Management:Proactively review and purchase all office and food supplies.Perform light conference room and multi-function copier maintenance.Act as primary vendor contact for multiple office-service vendors.Manage and track parking passes for Vedanta team members.Manage, track, and assign seating.Act as primary liaison with the building management team.Manage catering and smaller-scale food orders for meetings and company-wide events.Conduct ad hoc project and administrative support for the business operations team.Requirements:Bachelor’s degree or commensurate experience and 5+ years of work experience, with at least two years of experience in an office setting.Ability to work Monday through Friday, onsite in Vedanta’s Cambridge office. The job requires bending, twisting, and remaining standing for extended periods.Mature and common-sense decision-making capability; this individual must be comfortable functioning independently at times, as the Admin team is small.Collaborative orientation as this role may be called upon to assist other groups on administrative-based projects as time and capability allows.Must be proactive and operate with exceptional organizational skills.Must be comfortable and capable of communicating with professionals at all levels, including senior leaders.Why join Vedanta Biosciences:Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Title: Contract - Office Manager & ReceptionistLocation: Cambridge, MAReports to: Executive Assistant The Role:The Office Manager will be responsible for the smooth functioning of the Vedanta office. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection. This includes reception duties, vendor management, stocking/ordering office supplies, and generally acting as the “hub” through which many office-based activities are conducted. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.
Engineering Manager
Company: 2seventy bio
Location: Cambridge
Posted Sep 21, 2023
(i.e Change Control, Deviations, CAPA, SOP’s, Audit support)Author SOP’s governing operation and maintenance practices for responsible systems.Establish and maintain the Company Asset Register and Maintenance Plans governing reliability and compliance for responsible systems.Identify, solicit, and negotiate contracts with service providers as needed for technical suitability and cost-effectiveness.Lead investigations and remedial plans at the site for significant equipment failures and process improvements.Maintain up-to-date instruction manuals, spare parts lists, schematics, drawings, etc. In accordance with 2seventy bios duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees, contractors, consultants and their families, and the community at large from infections disease that may be reduced by vaccinations. Experience with Siemens BMS, Rees Scientific is an advantageExperience with a CMMS is required. Experience with Blue Mountain is an advantageMust be self-motivated and able to work on multiple tasks with a minimum of supervisionAbility to communicate effectively 2seventy bio has a mandatory vaccination policy for the COVID-19 vaccination for all employees, contractors and consultants as of January 4, 2022. How you’ll make an impact:Facilities at 2seventy bio includes 250,000SF of office, R&D lab, clinical manufacturing suites and commercial QC labs in Cambridge, along with 35,000SF of R&D/office space in Seattle.This role is to provide 2seventy with engineering leadership and technical subject matter expertise across all engineering systems (both locations with a primary focus on Cambridge) to ensure business critical systems are designed, installed, qualified and maintained correctly delivering reliable operations for all 2seventy manufacturing and R&D activities.The position will develop, improve and maintain all engineering guidelines, SOP’s, maintenance plans and other documentation to ensure 2seventy’s compliance with all regulatory standards for our growing GMP operations and R&D activities.How you’ll spend your time:This role will serve as the Business & Technical System Owner for all Facilities Systems (Mechanical, Electrical, Plumbing + Controls). 2seventy bio may consider several factors in assessing whether an exemption is available through an interactive process. on all systems and equipment.Own the review and acceptance of newly installed and commissioned equipment and systems to ensure that all systems are designed and operating properly prior to acceptance.Deliver a strategic approach to Life Cycle Asset Management, ensuring consistent adoption and appropriate planning for capital replacement cycles.Who you are and what you’ve accomplished:Requires a Bachelor's degree in sciences or engineering-related fieldsAt least 7+ years of relevant experience in facilities / engineering position with a strong technical knowledge of HVAC, Lab Gases and Electrical is requiredAt least 3+ years of experience working in a Biotech/Pharmaceutical GMP setting is require, working with GMP processes and related documentationAt least 2+ in a role as Technical SME, troubleshooting MEP problemsExperience with facilities control and monitoring systems is required. Additional vaccinations beyond the Covid-19 vaccine may be added in the future. Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department. All requests for an exemption will be evaluated on an individual basis. This position will interact with a wide stakeholder base internally and externally to Facilities.Inform and influence the development of GxP strategy and policy and Infrastructure Engineering management; leadership in GxP regulatory compliance across all 2seventy sites, in full alignment with corporate business strategies.Lead the delivery of GxP engineering needs for FDA/MHRA/EMEA compliant facilities within 2seventy bio.Ensure that processes and systems for the Infrastructure Engineering services meet all national, corporate and local regulations in the area of regulatory and statutory compliance with a strong focus on cGMP.Understand industry trends and developments maintaining an external and cross-business awareness thinking broadly and strategically regarding issues relating to Infrastructure Engineering services so as to drive the delivery of best practice.Establish reliability key performance indicators that ensure that the Infrastructure Engineering services are meeting the overall delivery strategies.Provide technical consultancy across the wider Facilities organization in core discipline as required, and utilize external providers for detailed technical assessments as necessary.Take responsibility as the system owner of multiple complex infrastructure systems used throughout the facility.Oversee the delivery of control systems support for critical cGMP data acquisition, alarm, building management and environmental monitoring systems.Ownership for all quality related items associated with infrastructure equipment and systems.