Quality Control Manager (Contract)

Tessera Therapeutics; Somerville (MA); On-site; USD 83,000 - 96,000; Full time

Job summary

Tessera Therapeutics in Somerville, Massachusetts is seeking a Quality Control professional for a 6-month contract role supporting GMP testing and laboratory operations for gene therapy products. The successful candidate will manage QC lab logistics, release and in-process testing coordination, and sample management.

You will lead QC data review, reagent programs, and method performance, working independently and cross-functionally to keep testing on schedule and ensure data quality.

Qualifications

• BS/BA with 4+ years of related experience, MS with 2+ years of related experience, or PhD with 3+ years of related experience.
• Quality Control experience supporting GMP testing and/or manufacturing of gene therapy or gene editing products, ATMPs, or equivalent
• Supporting or leading laboratory operations such as logistics for GMP manufacturing or testing, sample inventory management, and/or critical reagent program management
• Multitasking effectively while working both independently and cross-functionally

Responsibilities

• Managing operational aspects of the QC laboratory, including laboratory maintenance activities and scheduling/coordination of GMP release and in-process testing
• Overseeing sample management and logistics, including QC sample inventory management, sample transfer/receipt, and sample shipment to external test and storage sites
• Managing critical reagent programs and trending method performance
• Reviewing QC data generated from compendial and platform assays to support GMP release and stability testing

Skills

Quality control

GMP testing

Lab operations management

Multitasking

Education

BS/BA with 4+ years

MS with 2+ years

PhD with 3+ years

Job description

Somerville, Massachusetts, United States

• BS/BA degree with 4+ years of related experience, MS with 2+ years of related experience, or PhD with 3+ years of related experience
• Quality Control experience supporting GMP testing and/or manufacturing of gene therapy or gene editing products, ATMPs, or equivalent
• Supporting or leading laboratory operations such as logistics for GMP manufacturing or testing, sample inventory management, and/or critical reagent program management
• Multitasking effectively while working both independently and cross-functionally

You are interested in…

• Managing operational aspects of the QC laboratory, including laboratory maintenance activities and scheduling/coordination of GMP release and in-process testing
• Overseeing sample management and logistics, including QC sample inventory management, sample transfer/receipt, and sample shipment to external test and storage sites
• Managing critical reagent programs and trending method performance
• Reviewing QC data generated from compendial and platform assays to support GMP release and stability testing

About you:

You are a driven, enthusiastic, and self-motivated quality professional who is comfortable multitasking and working both independently and cross-functionally. As a member of the Quality Control team, you will lead aspects of QC laboratory operations and GMP method performance for analytical chemistry and molecular-based assays, managing the GMP laboratory operations that support internal testing of Tessera's drug substances and drug products. Your hands-on QC experience with gene therapy, gene editing, or other advanced therapy products, together with your background in GMP lab logistics, sample inventory, and critical reagent programs, positions you to keep testing on schedule and data quality high. This is a 6-month contract role with the potential for conversion.

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

Meet your Manager:

Dilip leads quality control operations at Tessera Therapeutics. He is responsible for release/stability testing of Drug Substances, Intermediates and Drug Product, Data Review, Equipment lifecycle and QMS activities.

Ben leads benefits and talent acquisition at Tessera Therapeutics. He shapes how the company attracts great people and supports them once they're here.

Ben started his career as an in vivo pharmacologist. That work gave him a lasting appreciation for the rigor, creativity, and collaboration behind scientific discovery, and it still shapes how he builds organizations where science can thrive.

He focuses on matching exceptional people with bold science and on creating an environment where they can do their best work. He'll guide you through the hiring process and can answer questions along the way.

Compensation:

The stated pay range represents Tessera's good-faith estimate for this role. Actual compensation will be determined based on a number of factors, including but not limited to individual qualifications, years of relevant experience, internal compensation alignment, and external market data.

Pay Range: $60.00 - $70.00 USD per hour

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.

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 [e-mail]