Senior Specialist, Quality Control

4 hours ago


Somerville, United States Tessera Therapeutics Full time
Your experience includes A Bachelor's degree in chemistry, biology, or related field with at least 5 years of related experience; or Master's degree and at least 3 years of related experience Quality Control roles supporting GMP testing/manufacturing of gene therapy or gene editing products, ATMPs or equivalent HPLC/UPLC-based assays and molecular based assays such as ddPCR or plate-based assays It's a bonus if you have supported QC laboratory operations such as logistics for GMP manufacturing, management of sample inventory and/or management of critical reagent program You are interested in Performing analytical assays (75% of time) as part of method qualifications, verifications and/or GMP testing Supporting operational aspects of the QC laboratory including equipment qualification, sample management and the critical reagent program Reviewing QC data generated from method qualifications, stability studies and/or GMP testing Supporting the method lifecycle lead in documentation/design of experiments for method qualifications and/or verifications About you : You are excited about leading/supporting aspects of QC laboratory operations and GMP method performance of analytical chemistry and molecular based assays. You are interested in joining the Quality Control team to assist in establishing and performing GMP methods to ensure readiness of QC in-process, release and stability test methods used for Tessera drug substances and drug products. You are a driven, enthusiastic and self-motivated individual who is comfortable multitasking and working both independently and cross-functionally on various aspects of the platform. 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. More about Tessera Therapeutics: 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. J-18808-Ljbffr

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