Manager/Senior Manager, Quality Control

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.
Position Summary:
The Quality Control Manager/ Sr. Manager will be responsible for QC laboratory operations and GMP method performance of analytical chemistry and molecular based assays. We are searching for a driven, enthusiastic and self-motivated individual who is comfortable multitasking and working both independently and cross-functionally on various aspects of the platform. The individual will join the Quality Control team and assist in establishing GMP procedures required for GMP laboratory operations as well as manage and perform GMP method performance to ensure readiness of QC in-process, release and stability test methods used for Tessera drug substances and drug products.
Key Responsibilities:

• Manage operational aspects of the QC laboratory including scheduling of GMP testing, stability studies and logistics, sample management and the critical reagent program
• Review QC data generated from method qualifications, stability studies and GMP testing
• Owning/reviewing quality events including laboratory investigations, deviations and change controls
• Report results from GMP testing within CoA or stability reports, as applicable
• Perform analytical assays (20% of time) as part of GMP in-process, release and stability testing of clinical drug substance and drug product
• Manage QC laboratory personnel, as team grows, which performs all GMP testing in support of clinical manufacturing
• Support external QC-related activities at CTOs/CDMOs such as review of QC data for release/stability and method development / qualification

Basic Qualifications:

• BS/BA degree and 8+ years of related experience, or Masters and 6+ years of related experience, or PhD and 3+ years of related experience
• Experience in Quality Control roles supporting GMP testing/manufacturing of gene therapy or gene editing products, ATMPs or equivalent
• Experience with HPLC/UPLC-based assays or molecular-based assays is a must (i.e., qPCR/ddPCR, SDS-PAGE, fluorometric assays), desire to expand analytical expertise highly preferred
• Experience in supporting or leading laboratory operations such as logistics for GMP manufacturing, logistics for stability testing, management of sample inventory and/or management of critical reagent program

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. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or Accommodations@tesseratx.com
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, 401(k) with company contribution, tuition reimbursement, and much more.
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. 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.