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Scientist I , Analytical Development & Quality Control
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Apr 25, 2024
<div> <p><strong><em>Attention recruitment agencies<em><strong><em> All agency inquiries are vetted through 4DMTs internal Talent Acquisition team No unsolicited resumes will be accepted Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future<em><p> <p><br ><p><p>4DMT is a clinicalstage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines We seek to unlock the full potential of gene therapy using our platform Therapeutic Vector Evolution TVE which combines the power of directed evolution with our approximately one billion synthetic AAV capsidderived sequences to invent evolved vectors for use in our products We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles These profiles will allow us to treat a broad range of large market diseases unlike most current genetic medicines that generally focus on rare or small market diseases <p> <p>We have built a deep portfolio of AVVbased gene therapy product candidates with five product candidates in clinical trials 4D150 for the treatment of wet agerelated macular degeneration wet AMD and diabetic macular edema DME 4D710 for the treatment of cystic fibrosis lung disease 4D310 for the treatment of Fabry disease cardiomyopathy 4D125 for the treatment of Xlinked retinitis pigmentosa XLRP and 4D110 for the treatment of choroideremia In addition we have two product candidates in preclinical studies 4D175 for geographic atrophy GA and 4D725 for alpha1 antitrypsin deficiency<p> <p>Todate we have demonstrated clinical proofofconcept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors We have built a robust and efficient product engine with 6 open Investigational New Drug Applications INDs in the US 1 IND in Taiwan and 1 Clinical Trial Approval CTA in Australia We believe we are positioned to create develop manufacture and if approved effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases<p> <p>In addition to TVE our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material This internal capability and close collaboration between our RampD and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT<p> <p>Company Differentiators <p> <p> Fully integrated clinicalphase company with internal manufacturing<br > Demonstrated ability to move rapidly from idea to IND<br > Five candidate products in the clinic and two declared preclinical programs<br > Robust technology and IP foundation including our TVE and manufacturing platforms<br > Initial product safety and efficacy data substantiates the value of our platforms<br > Opportunities to expand to other indications and modalities within genetic medicine<p> <div> <p><span datacontrast=auto>We are a highperforming innovative teambased organization where collaboration flexibility initiative energy and motivation is essential Reporting to the Senior Manager of ADQC the primary role of the Scientist I in Analytical DevelopmentQuality Control ADQC is to provide support to clinical programs by providing quality testing and delivering results in accordance with cGMP standards Ensuring our products are safe for patients and fit for purpose <span><span dataccpprops=> <span><p> <p><span datacontrast=auto>The Scientist I in Analytical DevelopmentQuality Control ADQC QC focus is responsible for authoring technical reports and protocols performing routine analytical testing data analysis method qualification and method validation The candidate will work closely with Process Development Manufacturing and Quality organizations to support raw material inprocess release and stability testing onsite The successful candidate will be experienced with analytical techniques including but not limited to qPCRddPCR AUC Biolayer Interferometry BLI electrophoresis ELISA CE CESDS cIEF and UVVis spectroscopy The successful candidate with have working knowledge of cGMP testing regulations <span><span dataccpprops=> <span><p> <p><span dataccpprops=><strong> Seeking Bay Area based candidates <span datacontrast=auto>GMP laboratory experience in the pharmaceutical industry required<span><strong><span><p> <p><span datacontrast=auto>RESPONSIBILITIES <span><span dataccpprops=> <span><p> <p><span datacontrast=auto>Routine Sample Testing and Data Analysis 30 of TIME<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>Perform testing of raw material inprocess release and stability samples under cGMP <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Maintain accurate and wellorganized laboratory records<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Perform primary review of QC raw data and trend results<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Draft technical reports using statistical analysis<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Review and present analytical data to crossfunctional teams<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Author QC SOPs and complete change control<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Support the authoring and review of CMC sections of INDs<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>Identify gaps and mitigate impact when industry guidelines or pharmacopeia sections are updated<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Train colleagues in areas of expertise <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=auto>Perform testing in support of process development<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=auto>Evaluate results against defined acceptance criteria<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>Method Qualification and Validation 40 of TIME<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=auto>Implementation of phaseappropriate test methods and specifications<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=auto>Identify trends that drive method requirements and ensure methods are fit for purpose<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=auto>Provide technical guidance as subject matter expert to QC staff<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=auto>Transfer optimize and troubleshoot analytical methods for use in Quality Control<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=16 dataarialevel=1><span datacontrast=auto>Draft analytical method Standard Operating Procedures<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=17 dataarialevel=1><span datacontrast=auto>Draft protocols and reports in support of analytical method qualifications <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=18 dataarialevel=1><span datacontrast=auto>Execute testing in support of analytical method qualification and validation<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>Quality System Oversight 30 of TIME<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>Maintain a cGMP compliant testing laboratory<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Perform equipment PMs and manage equipment calibration documentation<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Support implementation of new Laboratory Information Management System LIMS<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Author technical documents for reference material qualification studies<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Lead laboratory investigations<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Other duties as assigned nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>QUALIFICATIONS<span><span dataccpprops=> <span><p> <p><span datacontrast=auto>Education<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=none>PhD in a relevant scientific field MS Degree or <span><span datacontrast=auto>Bachelor of Sciences degree in a technical discipline Biochemistry Biology or related field is required <span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>Experience<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>8+ years of relevant hands on GMP laboratory experience in the pharmaceutical industry<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Strong background in assay qualificationvalidation under ICH Guidelines<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=auto>Knowledge of viral gene therapy adeno associated viral vectors preferred<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=auto>Ability to work independently and work with others in designing and developing experiments analyzing and interpreting data in a rigorous way<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=auto>Ability to multitask and support more than one project simultaneously<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=auto>Understanding and knowledge of key scientific software programs SoftMax QuantaSoft etc<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=auto>Understanding and knowledge of regulatory requirements for biologic products and cGMPs<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=auto>Strong organizational analytical and problemsolving skills<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=16 dataarialevel=1><span datacontrast=auto>Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via oneonone discussions team meetings and partnership interactions<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=17 dataarialevel=1><span datacontrast=auto>Experience with CMC activities for clinical programs<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=17 dataarialevel=1><span datacontrast=auto>Strong regulatory and GMP acumen<span><span dataccpprops=> <span><li> <ul><p><span dataccpprops=> <span><span datacontrast=auto>Skills<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Sound understanding of scientific principles<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>General understanding of compendial testing ICH qualificationvalidation<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Strong verbal and written communication skills and effective interpersonal technical discretion and troubleshooting skills are essential<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Must be a team player strong critical thinker exhibit a willingness to meet project timelines and multitask effectively in a dynamic fastpaced environment under challenging timelines<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Proficient or familiar with Microsoft based Windows programs Word Excel and PowerPoint<span><span dataccpprops=> <span><li> <ul><p>BASE SALARY COMPENSATION RANGE<p> <p><span dataccpprops=>Bay Areabased candidates $128000yr $149000yr<span><p> <p><br ><br ><p><div> <p>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws<p> <p> <p> <p>Equal Opportunity EmployerProtected VeteransIndividuals with Disabilities<p> <div>
Associate Director, Clinical Science
Company: Maze Therapeutics
Location: Peninsula
Posted Apr 25, 2024
Maze Therapeutics is seeking an Associate Director, Clinical Science to join their team and contribute to the development of life-saving medicines. The role involves designing, conducting, and interpreting clinical trials for genetic therapies, particularly for chronic kidney disease. The ideal candidate should have a PhD/MD/PharmD with 4+ years of drug development experience or an MA/MS/MSN degree with 7+ years of industry experience. They should possess strong organizational, analytical, and communication skills, and be willing to travel domestically and internationally. Maze Therapeutics offers a competitive salary and benefits package.
Manager, Study Start Up
Company: Eikon Therapeutics
Location: New York City, NY
Posted Apr 24, 2024
Eikon Therapeutics is seeking an experienced Manager, Study Start Up expert. The role involves improving operational excellence and efficiency in clinical trial execution, driving study feasibility deliverables, and supporting Clinical Development Operations Study Planning. The ideal candidate should have a post-graduate degree or bachelor's degree with relevant experience, a solid understanding of US and global regulations, and significant experience in the pharmaceutical industry or CRO. Strong analytical and project management skills, adaptability, and excellent communication skills are required. Eikon offers competitive compensation, benefits, and a safe work environment, requiring full vaccination against COVID-19.
Data Scientist Principal - Remote
Company: Prime Therapeutics
Location: Remote
Posted Apr 25, 2024
The job posting is for a Principal Data Scientist position, which involves using data science tools to develop predictive models for healthcare programs. The role requires a strong background in statistics, mathematics, or a related field, and at least 8 years of experience with large data sets and open-source tools. The position may involve supervising less experienced analysts and data scientists. The company, Prime Therapeutics LLC, values diversity and offers competitive pay and benefits.
Benefits, HR Operations & Compensation Manager
Company: Fulcrum Therapeutics
Location: Cambridge
Posted Apr 23, 2024
<p><strong>Company Overview <strong><p> <p>Fulcrum Therapeutics is a clinicalstage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need Fulcrums two lead programs in clinical development are losmapimod a small molecule for the treatment of facioscapulohumeral muscular dystrophy FSHD and pociredir a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies The companys proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene misexpression<p> <p><strong>Description<strong><p> <p>This role reports to the Chief People Officer This person will administer Benefits HR systems Metrics Compensation and support various HR projectsinitiatives This is a great opportunity to go across the HR function acting not only as a specialist but also as a utility player wherever needed <p> <p><strong>Responsibilities<strong><p> <p><em>Benefits Administration<em><p> <ul><li>Administer Fulcrums employee benefits plans including retirement plans leave policies wellness programs and insurance policies such as health life and disability This includes coaching educating and administering all programs while ensuring compliance of plans<li> <li>Participate in the selection of benefit vendors and oversee enrollment renewal and delivery of benefits to the FULCrew Work with CPO on benefits renewaleducation around plan changesopen enrollment for upcoming plan year<li> <li>Collaborate with benefits broker to stay abreast of emerging trends and proactively put forward recommendations that enable Fulcrum to be competitive<li> <li>Oversee amp audit invoices for accuracy<li> <li>Partner with Benefits Broker and 401k advisor when needed<li> <ul><p><em>HR Operations<em><p> <ul><li>Manage all HR systems and be the internal expert Paylocity Greenhouse Quantum 401k admin etc<li> <li>Operationally assisting with the onboarding process in terms of Paylocity HRIS system and benefits for new hires<li> <li>Manage the EVerify program for I9 submissions<li> <ul><p><em>HR General Support<em><p> <ul><li>Functions as a generalist in a variety of Human resources activities such as recruiting training amp development cultural activities HR ad hoc projects etc<li> <ul><p><em>Compensation Administration<em><p> <ul><li>Work closely with HR team to support compensation initiatives such as mid amp year end planning preparing comp committee materials and supporting comp projectsinitiatives<li> <li>Provide support during mid amp year end process merit bonus equity and ensure all necessary changes are entered into HR system<li> <li>Participate in annual RadfordAon compensation survey and ad hoc compensation projects<li> <li>Works closely with the Chief People Officer on preparation of materials for the Compensation Committee of the Board of Directors<li> <ul><p><strong>Qualifications<strong><p> <p>EducationExperience <p> <p>Bachelors degree plus 57 years of professional level experience Certified Employee Benefit Specialist CEBS a plus <p> <p>Requirements <p> <p>Experience in Benefits required Knowledge of benefits programs including health insurance longterm disability programs workers compensation insurance unemployment regulations life insurance 401k amp Defined Benefit plans COBRA etc Thorough knowledge of state and federal regulations related to benefits administration Understanding of human resource policies and programs<p> <p>SkillsAbilities <p> <ul><li>Experience in BiotechPharmaLife Sciences preferred<li> <li>Excellent oral and written communications abilities<li> <li>Excellent judgment and decisionmaking skills<li> <li>Strong analytical skills and detail orientation<li> <li>This position is hybrid 50 in office and will be primarily located in Cambridge MA<li> <ul>
Senior IT Analyst - Remote
Company: Prime Therapeutics
Location: Remote
Posted Apr 25, 2024
The job posting is for a Senior IT Analyst position, which involves analyzing, evaluating, and redesigning business, IT, or operational processes. The role requires strong organizational skills, attention to detail, and the ability to work independently while delivering high-quality outputs. The candidate will collaborate with software engineers, translate business needs into technical specifications, and ensure the highest quality product delivery. The position also involves testing applications, communicating cross-functionally, and thriving in ambiguity and rapid change. The required experience includes problem-solving techniques, hands-on experience with queries and reports, understanding of technical specifications, and experience with industry standard systems. The preferred experience includes Agile Methods and analytical programming languages like SQL. The potential pay range is from $66,880.00 to $107,000.00 based on experience and skills.
Contract Research Associate, Gene Editing
Company: Beam Therapeutics
Location: Cambridge
Posted Apr 25, 2024
Beam Therapeutics is hiring a Contract Research Associate to support the Gene Editing Technology Development team. The role involves managing inventory, preparing media and reagents, performing molecular cloning, bacterial culture, and cell line maintenance. The candidate should have a life science degree, relevant lab experience, and proficiency in molecular biology workflows and data analysis tools. The position requires onsite presence.
Senior Scientist, Bioanalytical Development
Company: Life Edit Therapeutics
Location: Raleigh-Durham, NC
Posted Apr 24, 2024
<p><strong>The Role<strong><p> <p>Life Edit is seeking a seasoned bioanalytical scientist with strong organizational communication and strategic skills and the desire to be part of a highly collaborative and crossfunctional team The selected candidate will develop execute qualify and validatetransfer assays as part of a highly collaborative and crossfunctional team to quantitate and characterize Life Edits novel RNAguided nucleases RGNs and gene editing programs as they move from research through to preclinical evaluation and eventual clinical advancement<p> <p><br ><p><p><strong>Heres What Youll Do<strong><p> <ul><li>Develop qualify and validate as appropriate bioanalytical assays expressions assays including mRNA and protein ELISAIHC antiAAV capsid nAb CTL IFNγ ELISPOT IgGIgM biodistribution and shedding for all programs and define sciencedriven phase appropriate and riskbased analytical development strategies to support the development candidate during discovery through preclinical evaluation including GLP and clinical development advancement<li> <li>Ensure adequate rigorous laboratory practices in a regulatory ready research manner<li> <li>Represent Bioanalytical Development on project teams<li> <li>Evaluate interpret and compile bioanalytical data into study reports for regulatory filing<li> <li>Critically summarize and present data internally to interdisciplinary teams as well as externally<li> <li>Write SOPs for analytical methods protocols and reports and provide training on process and equipment<li> <ul><p><strong> <strong><p> <p><strong>Requirements<strong><p> <ul><li>PhD in chemistry biology biochemistry or related life sciences field with at least 5+ years of relevant experience or MS with at least 12+ years of relevant experience<li> <li>Have knowledge of the execution and implementation of the bioanalytics associated with RNA or AAV gene therapy with gene editing preferred<li> <li>Experience with independent research leading projects and managing CROs<li> <li>Knowledge of laboratory practices with relevance to GLPGMP sample handling and analysis with associated documentation<li> <li>Experience with supervising laboratory staff and managing direct reports via positive motivation through clear and transparent communication and mentorship<li> <li>Demonstrates effective decisionmaking to steward and prioritize activities to support drug candidate and development programs<li> <li>Train and mentor scientists on bioanalytical techniques and scientific methodology<li> <li>Produce formal reports for internal use and regulatory filings<li> <li>Knowledge of FDA guidance and compliance and ability to oversee assays under prescribed GLPGMP protocols<li> <li>Good oral and written communication skills<li> <ul><p><br ><p><p>Were committed to finding the best ways to support our teams so they can do their best work We take care of our employees right from the start<p> <p><strong>Health amp Wellness<strong><p> <ul><li>Medical vision and dental insurance covered at 90<li> <li>Low deductible no coinsurance and no copays for mental health visits for innetwork care<li> <li>Annual fitness reimbursement<li> <li>Employer paid for access to wellness apps and programs like Task Human<li> <ul><p><strong>Financial<strong><p> <ul><li>Competitive compensation<li> <li>401k retirement plans with a 4 employer match and no vesting period<li> <li>Employerpaid life insurance and short and longterm disability insurance<li> <li>Employersponsored flexible spending accounts FSA and dependent care account DCA<li> <li>Access to a 1on1 financial advisor<li> <li>Commuter reimbursement benefit<li> <li>Monthly cell phone stipend<li> <ul><p><strong>Time Off amp Flexibility<strong><p> <ul><li>Unlimited paid time off including vacation sick leave family leave personal days and bereavement<li> <li>18 paid company holidays plus an endofyear holiday shut down<li> <li>12 weeks of parental leave<li> <li>Federal Family and Medical Leave Act FMLA and Massachusetts Paid Family and Medical Leave PFML administered by Unum<li> <ul><p><strong>Development Journey<strong><p> <ul><li>Insights Discovery training for every employee to make the most of workplace relationships<li> <li>Ongoing professional development including manager training<li> <li>Access to LinkedIn Learning a selfguided online education platform<li> <ul><p><br ><br ><p><div> <p><strong>Why join Life Edit and the ElevateBio ecosystem<strong><p> <p>Life Edit Therapeutics is an integrated subsidiary of ElevateBio a technologydriven cell and gene therapy company that is accelerating access to the cuttingedge technologies and expertise that can change the future of medicine Our integrated model combines multiple RampD technology platforms including Life Edit gene editing and cGMP manufacturing to power the discovery and development of advanced therapeutics Our ecosystem is designed to enhance speed delivery and probability of success to change patient lives<p> <p>Life Edit is an integral part of ElevateBios ecosystem of platform technologies and is pioneering focused nextgeneration gene editing technologies and therapeutics Located in Durham NC members of Life Edit work closely with the ElevateBio Research and Development and BaseCamp manufacturing teams in Waltham MA Life Edit is advancing therapeutic programs in collaboration with industry partners while building its own internal pipeline of gene editing therapies We are looking for a unique individual who can continue to lead the cultural development of Life Edit and build on its momentum as an integral part of the ElevateBio ecosystem<p> <p><strong>Our Mission<strong><br >To power the creation of lifetransforming cell and gene therapies at a speed the world deserves<p> <p><strong>Our Vision<strong><br >We seek to be the worlds most indispensable cell and gene therapy technology company redefining how companies operate how products are created and how disease is treated<p> <p><em>ElevateBio is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color gender age religion national origin ancestry disability veteran status genetic information sexual orientation or any characteristic protected under applicable law ElevateBio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law<em><p> <div>
Senior Forecast Analyst - Remote
Company: Prime Therapeutics
Location: Remote
Posted Apr 25, 2024
The job posting is for a Senior Forecast Analyst position at Prime Therapeutics LLC. The role involves providing complex financial modeling, forecasting, and analysis for various functional areas. The analyst will be responsible for creating new methodologies, reports, and analytical models, and providing critical analysis related to Requests for Proposals (RFPs) and client guarantees. The ideal candidate should have a Bachelor's degree in Finance, Math, Economics, or related field, and at least 5 years of experience in detailed analytical work in financial, insurance, pharmacy benefits management, reporting & analytics, benefits consulting healthcare industries or related field. The role requires excellent verbal and written communication skills, proficiency in Microsoft Excel, and the ability to work independently while maintaining accuracy and attention to detail.
Sales Enablement Specialist – N
Company: Prime Therapeutics
Location: remote
Posted Apr 24, 2024
The Associate Strategic Sales Specialist role at Prime Therapeutics LLC involves assisting in the development and execution of sales strategy to promote client growth and retention. The role requires leveraging CRM to track sales goals, partnering with the sales team during the RFP process, conducting background research on prospects, and providing competitive tracking insights. The ideal candidate should have a Bachelor's degree in Marketing, Business, Analytics, or related field, 2+ years of experience in healthcare, and strong analytical and observational skills. The role offers a competitive pay range and benefits package.
Senior Director, IT Infrastructure, UX & Security
Company: Tessera Therapeutics
Location: Somerville
Posted Apr 24, 2024
<div> <p><strong>Company Summary<strong><p> <p>Tessera Therapeutics is pioneering Gene Writing™ a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome thereby curing diseases at their source Gene Writing holds the potential to become a new category in genetic medicine building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach utilization and efficacy Tessera Therapeutics was founded by Flagship Pioneering a life sciences innovation enterprise that conceives resources and develops firstincategory companies to transform human health and sustainability<p> <div> <p><strong>Position Summary<strong><p> <p>We are seeking a dynamic Senior Director to build and lead the IT team at Tessera Therapeutics This position reports directly to the Senior Vice President of Digital Systems and will offer an exciting opportunity to take on IT leadership for a fast growing Gene Therapy company This team will be responsible for IT services infrastructure projects security and partner relationships This includes but not limited to<p> <ul><li>Oversight and execution of enterprise ITrelated projects across the facets of the company<li> <li>Planning coordination delivery and change management for enterprise IT projects<li> <li>Collaborating on systems roadmaps to meet strategic and operations needs of the company<li> <li>Oversight of core IT infrastructure services and partners<li> <li>Implementation of digital security policies<li> <ul><p><strong>Key Responsibilities<strong><p> <ul><li>Collaborate with company stakeholders to define business systems roadmaps including enterprise architecture amp security to meet strategic and operational needs of the company<li> <li>Responsible for implementation and operation of all site and company infrastructure end user computing supporting lab computing needs<li> <li>Responsible for overall IT process development documentation amp oversight eg user vendor amp company onboarding offboarding end user support lab support and emergency management<li> <li>Own the coordination implementation and change management related to crossenterprise IT projects not in the areas of GampA and GxP<li> <li>Coordinate with stakeholders on implementation of security policies and manage the overall security strategy for the companys growth<li> <li>Responsible for developing productive and strong company end user executive internal stakeholder as well as vendor and partner relationships Also critical to build connections and relationships across the other digital teams in order to meet strategic and operational needs of the company<li> <li>Work with company finance and contracts teams for all ITrelated budget planning and ongoing financial management within enterprise IT<li> <ul><p><strong>Basic Qualifications<strong><p> <ul><li>BSBA degree in Computer Science Business Information Systems or another related field and 15+ years of handson IT management experience and a minimum of 5 years experience in the biotech andor pharmaceutical industry<li> <li>Extensive and handson expertise in <ul><li>Business systems requirements roadmaps implementation amp operations in a Biotech setting including manufacturing amp clinical systems<li> <li>End user computing systems ie Mac PC mobile devices<li> <li>Identity management eg Okta<li> <li>SAAS applications eg 0365 Zoom Slack etc<li> <li>Experience migrating to a Microsoftcentric environment<li> <li>Meeting room technology<li> <ul><li> <li>Experience with and understanding of <ul><li>Cloud computing<li> <li>Networking<li> <li>Information Security<li> <ul><li> <li>Experience managing technology projects especially managing IT aspects of high growth buildouts<li> <li>Extensive vendor management experience<li> <li>Strong interpersonal and relationship management skills<li> <li>Friendly communicative collaborative approach and style<li> <ul><div> <p><strong>More about Tessera Therapeutics<strong><p> <p>Tessera is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race color religion age sex national origin disability status marital status genetics protected veteran status citizenship status sexual orientation gender identity or expression or any other characteristic identified by federal state or local laws where we operate Tessera provides reasonable accommodations to qualified applicants and employees with disabilities To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process andor to perform the essential functions of the position for which the applicant has applied please contact the recruiter or Accommodationstesseratxcom<p> <p>Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health wellness and financial security of our employees and their families Benefits currently include group medical vision and dental coverage group life and disability insurance 401k with company contribution tuition reimbursement and much more<p> <p> <p> <p><strong><em>Recruitment amp Staffing Agencies<em><strong><em> Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics internal Talent Acquisition team Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics and Tessera Therapeutics will not owe any referral or other fees with respect thereto<em><p> <div>
Senior Manager, Supply Planning
Company: Allogene Therapeutics
Location: Peninsula
Posted Apr 24, 2024
<p><strong><span>About Allogene<span><strong><p> <p><span>Allogene Therapeutics with headquarters in South San Francisco is a clinicalstage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell AlloCAR T™ products for cancer and autoimmune disease Led by a management team with significant experience in cell therapy Allogene is developing a pipeline of offtheshelf CAR T cell product candidates with the goal of delivering readily available cell therapy ondemand more reliably and at greater scale to more patients For more information please visit wwwallogenecom and follow AllogeneTx on X formerly Twitter and LinkedIn<span><p> <p><span> <span><p> <p><strong><span>About the role<span><strong><p> <p><span>Allogene Therapeutics is seeking a highly motivated Senior Manager Supply Planning to lead planning for cell therapy drug product and starting material production The position will ideally be located in South San Francisco CA or Newark CA but also open to remote employee in the US The ideal candidate is an individual who is interested in working in a fastpaced dynamic and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges <span><p> <p><span> <span><p> <p><span>We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role<span><p> <p><span> <span><p> <p><span>Responsibilities include but are not limited to<span><p> <ul><li><span>Develop detailed production plans for all applicable cell therapy programs<span><li> <li><span>Responsible for meeting supply requirements while balancing resource capacity utilization clinical requirements and inventory levels <span><li> <li><span>Lead planning and allocation of cell therapy starting materials<span><li> <li><span>Manage Sales and Operations Planning process to ensure alignment of clinical and commercial demand manufacturing capacity and the budget <span><li> <li><span>Represent Supply Chain for program specific CMC meetings<span><li> <li><span>Continually define and review planning and inventory strategy to support applicable sites<span><li> <li><span>Coordinate with External Manufacturing to ensure supply of maketoorder starting materials<span><li> <li><span>Proactively identify and mitigate any potential supply interruptions<span><li> <li><span>Drive CAPAs change controls SCARs as needed<span><li> <li><span>Lead Supply Chain scenario assessments as needed<span><li> <li><span>Potential to build and manage team as needed to accommodate company growth<span><li> <li><span>Other duties as assigned<span><li> <ul><p><span> <span><p> <p><span>Position Requirements amp Experience<span><p> <ul><li><span>Bachelors required degree in supply chainscienceengineering is a plus Masters degree in business management MBA preferred<span><li> <li><span>Experience in an Operations role in the Life Sciences andor Medical Devices industry<span><li> <li><span>Strong background in biotechnology supply chain planning and demand management<span><li> <li><span>Ability to communicate and collaborate with different stakeholders including with Manufacturing Quality Regulatory Clinical Operations Commercial Process Development Finance and others<span><li> <li><span>Excellent presentation skills including communication and influence with all levels of staff including executives<span><li> <li><span>Ability to effectively work in a fastpaced biotech environment while dealing with ambiguity<span><li> <li><span>Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines<span><li> <li><span>Ability to work independently and as part of a team<span><li> <li><span>Strong quantitative and qualitative skills with a high aptitude for problemsolving in a GMP environment<span><li> <li><span>Ability to objectively evaluate optionstradeoffs and develop executive managementlevel recommendations<span><li> <li><span>Fluency in an ERP system for demandsupply planning is preferred<span><li> <li><span>Proven leadership skills and organizational management experience<span><li> <li><span>Experience developing and mentoring staff preferable<span><li> <li><span>Candidates must be authorized to work in the US<span><li> <ul><p><span> <span><p> <p><span> <span><p> <p><span>We offer a chance to work with talented people in a collaborative environment and provide a topnotch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off including 2 annual holiday companywide shutdowns and much more The expected salary range for this role is $160000 to $190000 Actual pay will be determined based on experience qualifications geographic location business needs and other jobrelated factors permitted by law<span><p> <p><span> <span><p> <p><span>As an equal opportunity employer Allogene is committed to a diverse workforce 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 nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws 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 lifechanging products for patients<span><p> <p>LIEL1<p>