Jobs at Click Therapeutics
249,921 open positions
Staff Software Engineer
Company: Click Therapeutics
Location: New York City, NY
Posted Sep 27, 2023
Experience developing software with React.js, React Native, Node.js, AWS, kubernetes. Click Therapeutics will conduct interviews face-to-face over Zoom. All job postings will be listed on the Click Therapeutics official career page. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | Lunch Stipends | Parent Benefits | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More...Equal Employment Opportunity:Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Qualifications: B.S. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below. The final base salary will be dependent upon skills, experience and location. If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click's recruitment team at [email protected] to confirm before proceeding. All applicants must have authorization to work for Click Therapeutics in the U.S.
Senior Account Executive
Company: Force Therapeutics
Location: Remote
Posted Sep 29, 2023
We base all employment decisions on merit, qualifications, and business needs, without regard to race, color, religion, belief, national or social origin, sex, age, physical or sensory disability, HIV status, sexual orientation, gender identity/expression, marital status, military service, or any other protected status. *Salaries are determined based on qualifications, experience, and other relevant factors. Backed by millions of clinically validated patient data points and insights from more than 70 leading healthcare centers across the country, Force Therapeutics is proven to reduce care variation, lower overall costs, maximize care team efficiency, and improve patient outcomes and satisfaction.At Force Therapeutics, the well-being and growth of our team members comes first. With each challenge, you harness the collective teamwork of Force’s collaborative network to support your sales goals. Why Force Force Therapeutics is a musculoskeletal digital care management platform designed to help clinicians effectively manage patients’ rehabilitation and recovery remotely using evidence-based care pathways. Our robust benefits package reflects this commitment, ensuring that every aspect of our employees' professional and personal lives is supported:Medical, Dental, and Vision Insurance: Comprehensive coverage to ensure you and your family's health needs are always met.401k Retirement Planning: To set you up for long-term financial security with a company match. Pre-tax Commuter Benefits: Making your daily commutes more affordable and manageable.Generous PTO: Ample vacation time, including unlimited safe and sick time, volunteer time off, and extra holidays, so that you take the time you need.Summer Fridays: A nod to work-life balance, ensuring you get the most out of those sunny summer days.Remote-Friendly Workplace: We believe doing your best work means providing the flexibility to do that work in the environment where you feel most productive. Pay Transparency Notice At Force Therapeutics, we prioritize transparency and fairness in all aspects of our business, including the way in which we compensate our people. Adjustments may be made to accommodate local market conditions and geographic cost-of-living differences.Equal Opportunity Employment at Force Force Therapeutics values diversity and is committed to creating an inclusive environment for all team members. Our intention is to provide equal opportunities, eliminate pay gaps, and maintain competitive salaries benchmarked against industry standards.The base salary range for this role is : $100,000 - $120,000 per annum*In addition to the base salary, this role has a variable commission structure. To ensure that all candidates and employees understand our compensation structure, we provide clarity on pay ranges for each role. The projected on-target earnings (OTE) for this position is up to 50% of base compensation, contingent on meeting sales or performance metrics. You’ll also build, maintain, and leverage deep relationships to create the right solution for every prospect.Sales Operational Excellence: You’ll champion and proselytize internal sales best practices, including salesforce reporting.
Senior Accountant
Company: LEXEO Therapeutics
Location: New York City, NY
Posted Sep 23, 2023
We welcome applications from candidates located across the Northeast and Mid-Atlantic.Primary ResponsibilitiesParticipate in the monthly and annual accounting closing processes and contribute to producing accurate and timely financial statements;Prepare all recurring monthly journal entries;Maintain all balance sheet reconciliations and update monthly to ensure accurate reporting;Provide detailed fluctuation analysis for month end closing;Maintain effective internal controls and prepare annual internal control process narratives and key control analysis;Assist AP Specialist in proper coding of invoices;Ensure financial records are maintained in compliance with GAAP;Support financial statement audits and reports;Collaboration with operational personnel on financial and operational matters; andSpecial projects and other assignments as required.Required Skills & QualificationsBA/BS degree in Accounting or related field3-5 years of experience in an Accounting roleAbility to work effectively with all levels of an organizationStrong analytical skills with a high level of accuracy and attention to detailAbility to manage competing priorities and deadlines and strong problem-solving skillsStrong written and verbal communicationIntermediate or Advanced aptitude in Excel is requiredCPA or equivalent (or on-track) preferredExperience with a Big 4 or national firm, SEC registered company and/or Biotech company is preferredFamiliarity with NetSuite and FloQast a plusAnticipated Salary RangeDepending on qualifications and overall experience, base salary is likely to be $90,000 - $115,000 per year.LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. As Senior Accountant, you will be the primary preparer of most accounting workpapers and support, reporting to the Assistant Controller and working with the AP Specialist. This is an exciting opportunity to contribute to the advancement of cutting-edge medical treatments and shape the future of healthcare.LocationOur work culture is a hybrid model with days in the New York City office and days working from home. Role SummaryWe are seeking a highly motivated Senior Accountant to join our growing team.
Senior/Principal, IP Paralegal
Company: Allogene Therapeutics
Location: Peninsula
Posted Sep 29, 2023
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.LI-EL1 Responsibilities include, but are not limited to:Provide legal assistance on intellectual property matters Coordinate paper and eFiling of patent applications and patent prosecution documents Keep abreast of rule changes in patent and trademark prosecution practices in US and world-wideAssist in patent litigation and other adversarial IP matters Assist IP attorneys with the drafting and editing of various contract documents Maintain contract database Maintain tracking/docketing system for patents and trademarks Coordinate invention disclosures from Research & Development Track and monitor IP legal fees Other duties as assigned Position Requirements & Experience:Bachelor’s degree with at least 7 years of relevant intellectual property experience as a paralegal in law firms and/or companies, preferably in a biotech or pharma company Paralegal certification knowledge and understanding of global regulations and guidelines Ability to regularly communicate highly confidential information to senior level staff and maturity to maintain confidential information Proficient in MS-Word, Excel, PowerPoint, Outlook and related software; experience with Foundation IP is a plus Excellent attention to detail, organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity Ability to anticipate issues and provide practical solutions We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The focus will be on patent matters, but knowledge in trademarks and contracts a plus. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. The successful candidate will report directly to the Head of IP and will be interested in working in a fast-paced, dynamic and highly collaborative start-up environment with a willingness to take on new challenges. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.About the role:Allogene Therapeutics is seeking a highly motivated Senior/Principal IP Paralegal to support the legal department on intellectual property matters. The expected salary range for this role is $100,000 to $140,000.
Associate Scientist I/II -- Protein Production
Company: Dragonfly Therapeutics
Location: Waltham
Posted Sep 23, 2023
We offer a unique opportunity to learn, grow professionally and be part of a fun, dedicated and goal-oriented team.Responsibilities:Manual and automated mammalian protein production (upstream and downstream)Bench-scale mammalian protein purification using column chromatography (Affinity, IEX, SEC, HIC) and FPLC/liquid chromatography (AKTA Pure, AKTA Avant)Molecular biology techniques including cloning, PCR, and plasmid DNA prepMammalian cell culture (Expi293, ExpiCHO) utilizing strong aseptic techniqueTecan liquid handler method development, optimization, validation, and execution for automated high-throughput (HTP) protein production (DNA cloning, mammalian protein expression (Expi293, ExpiCHO), and mammalian protein purification)Design of Experiments (DOE) applied statistical approach to upstream and downstream process development activities to expand existing HTP protein production capabilities and related QC activitiesPerform assorted analytical biochemistry techniques (Octet titer, SDS-PAGE, SEC-HPLC, protein quantification, LAL endotoxin, etc)Work closely with Biologics and Biology leadership teams to ensure that program timelines and milestones are met for the production processesDocument observations and data in electronic labAnalyze and present data at group meetingsQualifications:S. in relevant field with 2+ years of industry experience or M.S. with 0-1+ years of industry experienceFamiliarity with liquid handler platforms (Opentrons, Tecan) is preferredExperience with mammalian cell culture, molecular biology, protein purification, and analytical biochemistry techniquesExperience in method development, optimization, and troubleshootingCapable of operating independently with high level critical thinking and problem-solving experienceMust be detail-oriented with excellent organizational skills; diligent documentation and highly efficient time management are requiredPrevious success operating in a fast-paced, dynamic work environmentExcellent communication and interpersonal skillsAbout DragonflyDragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas. Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. The candidate would be responsible for optimization, and expansion of DNA cloning, protein expression and protein purification platforms in coordination with downstream functional teams. We believe in a small team with a big impact. Associate Scientist I/II, Protein ProductionDragonfly Therapeutics is seeking a highly motivated scientist with a strong focus in Molecular Biology and Protein expression and purification to join the Biologics team. The successful candidate will play a pivotal role in the DNA cloning and rapid generation of antibodies and multi-specifics at various scales to streamline discovery efforts.
Scientist, Analytical Development
Company: LEXEO Therapeutics
Location: New York City, NY
Posted Sep 23, 2023
Strong initiative, accountability and willingness to take ownership and drive projects to completionAccustomed to “roll up their sleeves” and execute the tasks needed in a small company environmentDepending on qualifications and overall experience, base salary is likely to be $110,000-$125,000 per year.LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. regulations, compliance and current industry best practicesRequired Skills & QualificationsBS with 4+ years, MS with 2+ years or Ph.D. in chemistry, biochemistry, life sciences, pharmaceutical sciences, chemical engineering or equivalentExperience in cell and gene therapy products.Experience with pharmaceutical drug-process validation and manufacture a plusKnowledge of FDA, cGMPs, and ICH guidelines and QBD principles a plusCross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity. Results oriented with breadth and depth in pharmaceutical development and commercial products to resolve complex problemsResults oriented, has a bias for action. This position requires collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. We are an early-stage company, so this is a highly visible and impactful role in our organization. LocationLEXEO Office located in New York, NY.Primary ResponsibilitiesDevelopment of phase-appropriate testing methodologies – including such assays as digital PCR, potency, quantitative PCR – for AAV gene therapy vectorsAssist in the development and internal testing of potency assays in a target-specific manner.Building in-house capability in analytical development for viral vectorsAssist in driving the analytical strategy of the organization and support regulatory activities for filing Assist in collaborating with CDMOs and CROs to support production and release of GMP materials Participate in technical transfer between laboratories, qualification/validation of assays and QC activities for material releaseTimely development of assays as well as testing of samples for material releaseIdentification and communication of risks in assay performance and their mitigationProvide support to the organization regarding analytical aspects, e.g. qPCR/ddPCR) assays and establishing the mechanism-of-action of AAVs in cellular systems using novel approaches. This includes development of cell based and molecular (e.g. Role SummaryReporting to the Senior Director, Analytical Development and Quality, the Scientist provides leadership in the development of analytical assays related to AAV-based gene therapy programs.
Associate Scientist, Process Development
Company: LEXEO Therapeutics
Location: New York City, NY
Posted Sep 23, 2023
You will have an opportunity to learn in a fast-paced startup company, while working collaboratively within a multidisciplinary team that is dedicated to the development of new therapies.LocationLEXEO Office located in New York, NYPrimary ResponsibilitiesPerform process development, process characterization and scale-up activities to enable high productivity, scalable and robust upstream processes for viral vector manufacturing.Serve as a subject-matter-expert for the upstream process development of viral vectors using stirred-tank bioreactor technologies.and/orServe as a subject-matter-expert for the downstream process development of viral vectors using chromatographic technologies.Design and execute laboratory studies to evaluate novel technologies to improve existing processes and establish manufacturing platforms.Engage in proactive relationships with partners including CMO/manufacturing team, a person in a plant, batch record/SOP review.Collaborate closely with the analytical team to evaluate critical gene therapy product characterization, critical quality attributes and process performance parameters, product characterization, and product release for gene therapy AAV vector production.Prepare manufacturing process data summary, process description, process report, and technology transfer reports.Assist with execution of process planning and resourcing critical material to ensure project progress aligns with company timeline.Familiar with applicable regulatory cGMP requirements for gene therapy.Required Skills & QualificationsBS/MS degree with 0-2+ years of relevant experience in Chemical Engineering, Biochemical Engineering,&8239;Biomedical Engineering, Biotechnology, Biochemistry, Microbiology, or related fieldsHands-on experience of upstream cell culture processes and stirred-tank bioreactor technologies to manufacture biologics or viral vectors or vaccines.and/orHands-on experience of downstream processes and chromatographic technologies to manufacture biologics or viral vectors or vaccines.Excellent communication and presentation skills, capable of conveying complex technical information in a clear, thorough, and influential manner is required.Excellent MS Office skills with a specific focus on word, excel and power point applications to author technical reports and presentations.Depending on qualifications and overall experience, base salary is likely to be $75,000-$85,000 per year.LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. As an early hire at a new company, you will have exposure to senior management, and you will be influential in championing and developing LEXEO’s culture. Role SummaryReporting to the Director, Process Development, this position will be responsible for developing and optimizing the production of AAV products in the lab and with collaborators with the goal of advancing the development of novel targets for cardiac and neurodegenerative disorders.
Senior Manager, Program Management
Company: Click Therapeutics
Location: New York City, NY
Posted Sep 25, 2023
Identify and problem solve program issues, including those related to timing, resources, and gating items, to prevent delays in program milestones. Click Therapeutics will conduct interviews face-to-face over Zoom. Work closely with cross-functional internal colleagues to manage execution of responsibilities, timelines, budget tracking, risk mitigation, and ensure program objectives are achieved. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | Lunch Stipends | Parent Benefits | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More...Equal Employment Opportunity:Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. The final base salary will be dependent upon skills, experience and location. Become an internal expert in the PDT market, Click's corporate strategy, and the product portfolio and pipeline processes to enable effective decision making, communication, and program activity alignment. All job postings will be listed on the Click Therapeutics official career page. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below. If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click's recruitment team at [email protected] to confirm before proceeding.
Sr. Accounting Manager
Company: CymaBay Therapeutics
Location: North Jersey
Posted Sep 27, 2023
Assess, streamline, and improve operational accounting policies and procedures to ensure efficiency and cost effectiveness.Collaborate, communicate concisely, and work cross-functionally with finance personnel, department managers, auditors, accounting consultants, and other stakeholders as necessary.Assist with other projects and process improvement initiatives as necessary.Qualifications:Bachelor’s degree in Accounting or Finance required.CPA certification required.Minimum of 5-7 years of relevant experience responsible for full-cycle month end close and financial reporting process in public commercial biotech companies under SOX 404(b) environment.Minimum of 2 years Net Suite system working experience.Minimum of 1 year of inventory accounting working experience.Ability to multi-task and effectively manage to achieve critical deadlines.Ability to work in a team-oriented environment and working experience in managing staff.Self-starter, strong work ethic, able to work independently with minimal supervision.Desire to continuously learn and improve finance processes, systems and controls.Strong written and verbal communication and interpersonal skills.Proficiency in Word, Excel, and PowerPoint.Working experience with inventory accounting auditing and Coupa a plus.Working knowledge of payroll accounting, Concur and ADP a plus.The anticipated salary range in Newark, California is $170-185K. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Reporting to Director, Accounting, this individual will be responsible for full-cycle general accounting operations including preparing or reviewing assigned journal entries, account reconciliations, and other accounting records, and shall drive the completion of closing procedures for monthly and quarterly financial reports. CymaBay is a multi-state employer, and this salary range may not reflect positions that work outside of the Bay Area or in other states. This position interacts with finance personnel, external auditors, accounting consultants, department managers, and other stakeholders.This position is located in Newark, CA with a hybrid work schedule (3 days in office and 2 days work from home).Essential Functions and Job Responsibilities:Responsible for full-cycle general accounting close procedures including preparing/reviewing assigned general and payroll journal entries, bank reconciliations, fixed assets and software cost capitalization transactions, inventory transactions, and prepare financial statements in accordance with GAAP and meeting SOX 404(b) requirement.Generate monthly financial reports and perform quarterly financial fluctuation analysis and SEC reporting package tie out.Working knowledge of capitalization of internal use software and implementation costs under ASC 350-40.Support audits, including but not limited to providing or reviewing SOX and financial audits workpapers.Responsible for filing compliance including sales and use tax, property taxes, 1099 reporting, and any other local jurisdiction reporting.Prepare schedules and support information requests for tax filing and various quarterly reviews and annual audits.Responsible for all financial systems and accounting controls within the area of responsibility.Ensure compliance with Sarbanes-Oxley 404 internal control policies and procedures, execute and document internal controls timely and accurately, and collaborate to revise and enhance internal control policies and procedures as needed.Collaborate with stakeholders as necessary to support the implementation of new accounting systems and technologies to support corporate growth and efficiency. We are looking for new team members to join our expanding organization.We are seeking a qualified, highly motivated, experienced Sr. Accounting Manager to support a growing organization. CymaBay Therapeutics, Inc. is a publicly traded, clinical-stage biopharmaceutical company based in Newark, California, focused on developing therapies for liver and other chronic diseases with high unmet medical need. This individual should be a team player who is comfortable being hands-on and working in a fast-paced environment that is subject to SOX 404b compliance and desires to develop professionally as the team and company grows.
Sr. Accountant
Company: CymaBay Therapeutics
Location: North Jersey
Posted Sep 27, 2023
Assess, streamline, and improve operational accounting policies and procedures to ensure efficiency and cost effectiveness.Collaborate, communicate concisely, and work cross-functionally with finance personnel, department managers, auditors, accounting consultants, and other stakeholders as necessary.Assist with other projects and process improvement initiatives as necessary.Qualifications: Bachelor’s degree in Accounting or Finance.Minimum of 5-7 years of relevant experience and 2 year of Net Suite system working experience Minimum 2 years of working experience in public commercial biotech companies under SOX 404(b) environment.Ability to multi-task and effectively manage to achieve critical deadlines.Ability to work in a team-oriented environment.Self-starter, strong work ethic, able to work independently with minimal supervision.Desire to continuously learning and improve finance processes, systems, and controls.Strong written and verbal communication and interpersonal skillsProficiency in Word, Excel, and PowerPointLate development stage, or commercial Biotech experience and working experience with inventory accounting, auditing and Coupa a plus.CPA training / certification a plus.The anticipated salary range in Newark, California is $105K-120K. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Reporting to Director, Accounting or Accounting Manager, this individual will be responsible for preparing various journal entries, account reconciliations, and other accounting records, and shall drive the completion of closing procedures for monthly and quarterly financial reports. CymaBay is a multi-state employer, and this salary range may not reflect positions that work outside of the Bay Area or in other states. This position interacts with finance personnel, external auditors, accounting consultants, department managers, and other stakeholders.This position is located in Newark, CA with a hybrid work schedule (3 days in office and 2 days work from home).Essential Functions and Job Responsibilities:Prepare monthly general journal entries such as bank entries, employee and credit card expense accruals entries, payroll journals, prepaid amortization, fixed asset depreciation, and overhead allocation.Reconcile bank accounts.Contribute month end-close cycle to ensure timely and accurate completion of financial reporting as a public company.Assist monthly financial report creation and perform variance for assigned accounts analysis.Collaborate with finance team members to ensure timely and accurate analysis and reconciliation of assigned general ledger accounts.Prepare journal entries in accordance with GAAP and SOX 404(b) control and documentation requirements.Prepare schedules and support information requests for tax filing and various quarterly reviews and annual audits.Ensure compliance with Sarbanes-Oxley 404 internal control policies and procedures, execute and document internal controls timely and accurately, and collaborate to revise and enhance internal control policies and procedures as needed.Collaborate with stakeholders as necessary to support the implementation of new accounting systems and technologies to support corporate growth and efficiency. We are looking for new team members to join our expanding organization.We are seeking a qualified, highly motivated, experienced Senior Accountant to support a growing organization. CymaBay Therapeutics, Inc. is a publicly traded, clinical-stage biopharmaceutical company based in Newark, California, focused on developing therapies for liver and other chronic diseases with high unmet medical need. This individual should be a team player who is comfortable working in a fast-paced environment that is subject to SOX 404b compliance and desires to develop professionally as the team and company grows.
Engineer/Sr. Engineer, Upstream Process Development
Company: Dragonfly Therapeutics
Location: Waltham
Posted Sep 27, 2023
Candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. The successful candidate will contribute and drive our upstream cell culture process development, while interacting regularly with other CMC functions. Responsibilities:Lead development of robust and scalable upstream processes for biologics in different stages of clinical development, including design, execution, analysis, and documentation of all stages of cell-culture process developmentSupport external manufacturing with technology transfer for implementation of new processes and provide person-in-plan support as requiredSupport process change controls, deviations, impact assessments, and perform batch record reviewImprove upstream processes through research and innovation, while assessing technologies and industry best practicesReview, collect and trend data from manufacturing batches to help identify trends, assess performance, build process understanding, and enable improvement activitiesChampion compliance and safety; promote a culture of diversity, inclusion, and equityMaintain good communication and collaborate with cross-functional colleagues and external partners for successful execution/completion of projectsAuthor and contribute to IND/IMPD/BLA submissionQualifications:BS/MS with 10+ years, or PhD with 2+ years of industry experience and background in Chemical/Biochemical engineering, or a related fieldStrong fundamental knowledge and subject matter expertise in cell-culture process development, fed-batch cell culture, bioreactors across scales, as well as recent advances, and challenges in the fieldExperience and aptitude to lead, work and collaborate in internal and external cross-functional, matrixed teamsWorking knowledge of cGMP and quality systemsAction-oriented mindset, ability to take initiative, innovate, iterate and problem solveExperience with cell culture and predictive modeling (omics, metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence a plusAbility and willingness for approximately 10% domestic travel consistent with project needsAbout DragonflyDragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas. Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. Engineer, Upstream Process DevelopmentDragonfly Therapeutics seeks an upstream process development engineer who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to help deliver novel immunotherapy programs. We believe in a small team with a big impact. Engineer/Sr. The successful candidate will excel in a highly collaborative work environment with a multi-disciplinary and diverse team focusing on multiple programs in parallel.
Associate Director, QA Operations
Company: Corcept Therapeutics
Location: Peninsula
Posted Sep 27, 2023
).Lead and Author Annual Product Review (APR) effort by working cross-functionally with Regulatory and CMC to gather the necessary data and information.Work cross-functionally with the Drug Safety team to resolve quality events that can include product quality complaints, adverse event (ADE) reports, and deviations that can stem from the PV service provider, Pharmacy, and or internal team.Evaluate and approve Product Quality Complaints (PQC).Author and revise Standard Operating Procedures (SOPs) as needed.Generate, review, and negotiate Quality and Technical Agreements with Contract Service Providers (CSP).Lead and support Contract Service Provider (CSP) qualification audits that can include contract manufacturers, contract testing organizations, distribution depots, PV service provider, and pharmacy.Identify and lead areas of continuous improvement pertaining to Quality Assurance.Support the management and growth of the Quality Assurance Operations team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs.Provide cross training development opportunities; mentor and coach junior QA team membersPreferred Skills, Qualifications and Technical Proficiencies: Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes.Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the disposition of pharmaceutical products.Ability to work independently and communicate effectively and concisely (both verbal and written) with project team members and management groups and CSPs.Work well in a project team environment with solid problem analysis and decision-making ability.Ability to lead or support internal and external compliance audits of suppliers, CLOs, and CMOs.Ability to work independently in addition to clearly and concisely communicate both in writing and verbalAbility to identify compliance risk and recommend mitigations.Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations.Strong statistical mindset and pragmatic decision making.Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio.Travel requiredPreferred Education and Experience: Bachelors or Masters degree in a chemistry, biology, engineering or related field.Thorough knowledge of 21 CFR 210/211 global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products.12+ years’ experience in bio/pharmaceutical industry including 7+ years in Quality Assurance.The pay range that the Company reasonably expects to pay for this position is $175,000 - $207,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. In addition, this role manages the Product Quality Complaint process and supports Drug Safety in regards to Pharmacovigilance activities (PV).Responsibilities:Act as the Quality Assurance (QA) lead in providing oversight and support in various Chemistry, Manufacturing, and Controls (CMC) projects.Perform review of batch records and test data and perform product dispositions.Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations.Review and approval of validation protocols and reports (e.g., process, method, etc. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. Applicants must be currently authorized to work in the United States on a full-time basis.If you are based in California, we encourage you to read this important information for California residents linked here.Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/Corcept is an Equal Opportunity Employer Today, we have a unique opportunity to revolutionize the treatment of severe endocrine, oncology, metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them.The Quality Operations Associate Director is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and disposition of pharmaceutical drug substance and drug product for commercial and clinical distribution. Our vibrant community is made up of over 300 people—medical practitioners, scientists, and industry professionals—all with the shared goal of advancing the science of cortisol modulation to treat serious disease.Our work has uncovered over 1000 proprietary selective cortisol modulators, including our marketed product, Korlym® (mifepristone), the first treatment available for those living with Cushing’s syndrome, a life-threatening condition caused by excess cortisol activity. That is why for twenty-five years we have pushed the boundaries of what is possible, driven by fiercely independent science, open collaboration and the curiosity to follow the data wherever it leads.Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee. At Corcept Therapeutics, we believe the potential impact of cortisol modulation on the future of health has long gone overlooked.