Senior Specialist, Quality Control

Posted 16 Days Ago
Be an Early Applicant
Somerville, MA
Senior level
Biotech
The Role
The Senior Specialist in Quality Control will perform analytical assays, support GMP laboratory operations, review QC data from method qualifications, and assist in documenting experiments. This role requires strong leadership and multitasking abilities within QC lab operations to ensure compliance and readiness for drug substance testing.
Summary Generated by Built In

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.

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.

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.

Top Skills

Hplc
Uplc
The Company
HQ: Cambridge, MA
262 Employees
On-site Workplace

What We Do

Our mission is to cure disease by writing the code of life

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