Manager/Senior Manager, QC (Method Lifecycle)

Your experience includes...

• A Bachelor's degree in chemistry, biology, or related field with at least 8 years of industry experience is required; or Master's degree and at least 6 years of industry experience
• Extensive experience in method development, qualification and/or validation of GMP methods used for clinical and commercial phases
• Previous experience in maintaining/remediation of QC methods across product lifecycle (i.e. method trending, method investigations or remediations)
• Strong understanding of regulatory guidance for method validation and verifications including ICH, USP, FDA and EU
• Previous laboratory experience with a diverse set up analytical skills including HPLC, ddPCR/PCR, plate-based/ELISA assays is required

You are interested in...

• Building/managing the Technical Support sub-function and personnel within Quality Control team
• Managing method qualification and verification activities for phase I/II clinical programs including processes, project-specific documentation and cross-functional communication
• Owning method qualification protocols/reports and standard operating procedures for internally and externally performed QC methods used for drug substances and drug products
• Managing Tessera’s QC critical reagent program and reference standard program
• Managing method lifecycle activities including method trending and remediation throughout product lifecycle

About you:

You are a driven, self-motivated individual who is interested in working as a team to ensure readiness of in-process, release and stability test methods for Tessera drug substances/products and phase I/II clinical programs. 

Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence.  

 

Meet Your Manager: 

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening.   

Amanda Fisher – Director, Quality Control

 

Meet Your Talent Partner: 

Annie Edminster (she/her) – Employee Experience and Talent Lead

 

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 Accommodations@tesseratx.com

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 strict