Tbwa Chiat/Day Inc
Manager/Senior Manager, Quality Control Somerville, Massachusetts, United States
Tbwa Chiat/Day Inc, Somerville, Massachusetts, us, 02145
Somerville, Massachusetts, United StatesMinimum Qualifications:
BS/BA/MA with 8+ years of experience, PhD with 4+ years of experienceQuality Control roles supporting GMP testing/manufacturing of gene therapy or gene editing products, ATMPs or equivalent is a mustHPLC/UPLC-based assays and compendia assays (i.e. visual appearance, TOC, conductivity) is a mustMethod development, qualification, and/or validation of GMP methods used for clinical and commercial phasesStrong understanding of regulatory guidance for method validation and verifications including ICH, USP, FDA and EUResponsibilities:
Managing method qualification and verification activities for phase I/II clinical programs internally and externallyManaging personnel leading performance of method qualification/verifications and GMP testing for phase I/II clinical programsPerforming analytical assays (25% of time) as part of method qualifications, verifications and/or GMP testingReviewing QC data generated from equipment qualification, method qualifications, stability studies and/or GMP testingManaging method lifecycle activities including investigations, method trending and remediation throughout product lifecycleAbout You:
You are a driven, enthusiastic, and self-motivated individual who is comfortable multi-tasking and working both independently and cross-functionally on various aspects of the platform. You are interested in assisting in establishing GMP methods to ensure readiness of QC in-process, release and stability test methods used for Tessera’s drug substances and drug products.Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence.Company Summary:
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 first-in-category companies to transform human health and sustainability.Equal Opportunity Employer:
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.Recruitment & Staffing Agencies:
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.Apply for this job
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BS/BA/MA with 8+ years of experience, PhD with 4+ years of experienceQuality Control roles supporting GMP testing/manufacturing of gene therapy or gene editing products, ATMPs or equivalent is a mustHPLC/UPLC-based assays and compendia assays (i.e. visual appearance, TOC, conductivity) is a mustMethod development, qualification, and/or validation of GMP methods used for clinical and commercial phasesStrong understanding of regulatory guidance for method validation and verifications including ICH, USP, FDA and EUResponsibilities:
Managing method qualification and verification activities for phase I/II clinical programs internally and externallyManaging personnel leading performance of method qualification/verifications and GMP testing for phase I/II clinical programsPerforming analytical assays (25% of time) as part of method qualifications, verifications and/or GMP testingReviewing QC data generated from equipment qualification, method qualifications, stability studies and/or GMP testingManaging method lifecycle activities including investigations, method trending and remediation throughout product lifecycleAbout You:
You are a driven, enthusiastic, and self-motivated individual who is comfortable multi-tasking and working both independently and cross-functionally on various aspects of the platform. You are interested in assisting in establishing GMP methods to ensure readiness of QC in-process, release and stability test methods used for Tessera’s drug substances and drug products.Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence.Company Summary:
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 first-in-category companies to transform human health and sustainability.Equal Opportunity Employer:
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.Recruitment & Staffing Agencies:
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.Apply for this job
* indicates a required field
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