Quality Control Manager

We are seeking a motivated and experienced Quality Control Manager to join our Technical Operations team in Berkeley. Reporting to the Associate Director of Analytical Development and Quality Control, you will have the opportunity to solve the obstacles that come with our team’s goal of improving the cell therapy manufacturing process.You’ll guide the company through compliant GMP manufacturing of clinical trial materials. This includes participation in selecting Contract Manufacturing Organizations, documentation, deviations, investigations, CAPAs, and change controls related to the manufacturing process.

Responsibilities include:

Manage stability program of Caribou critical raw materials and products
Perform trend analysis of stability data
Act as QC liason with outside testing contractors
Write and/or review QC test results, Certificates of Analysis, SOPs, deviation reports, change requests and CAPAs
Track validation status of analytical methods for Caribou programs. Perform gap analyses for validated test methods.
Serve as QC representative within department and in cross-functional areas
Qualifications:

Minimum 3+ years/Minimum 1+ year (PhD) or 2+ years (BS) managing a QC laboratory/Minimum 2+ years experience in method validation.
Experience working in a laboratory, performing and troubleshooting assays such as multi-color flow cytometry, ELISA, Luminex, qPCR, ddPCR and LC-MS
Strong knowledge of Good Documentation Practices and current GMP regulation
Experience with laboratory audits
Knowledge of laboratory equipment and software qualification
Strong analytical communication skills
Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
Ability to identify obstacles and problems and take the initiative to identify solutions and implement them in a timely manner
Demonstrated ability to work in cross-functional teams
Nice-to-haves:

Knowledge of basic statistics and statistical analysis software
Experience working in/with laboratories to support cell therapy products
Experience with qualification of cell-based potency assays
Strong writing skills
Caribou compensation and benefits include:

Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
Generous paid vacation time, in addition to company-observed holidays and floating holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Tuition reimbursement program
Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Caribou requires employees to be fully vaccinated, including a booster shot, against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.

For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.

To apply for this job please visit boards.greenhouse.io.

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