Your experience includes…
- BS/BA/MA with 8+ years of experience, PhD with 4+ years of experience
- Quality Control roles supporting GMP testing/manufacturing of gene therapy or gene editing products, ATMPs or equivalent is a must
- HPLC/UPLC-based assays and compendia assays (i.e. visual appearance, TOC, conductivity) is a must
- Method development, qualification, and/or validation of GMP methods used for clinical and commercial phases
- Strong understanding of regulatory guidance for method validation and verifications including ICH, USP, FDA and EU
You are interested in…
- Managing method qualification and verification activities for phase I/II clinical programs internally and externally
- Managing personnel leading performance of method qualification/verifications and GMP testing for phase I/II clinical programs
- Performing analytical assays (25% of time) as part of method qualifications, verifications and/or GMP testing
- Reviewing QC data generated from equipment qualification, method qualifications, stability studies and/or GMP testing
- Managing method lifecycle activities including investigations, method trending and remediation throughout product lifecycle
About 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.
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.
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. 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 [email protected]
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.
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What We Do
Our mission is to cure disease by writing the code of life
