Sr. Associate - Quality Control - Cell Therapy

Novo Nordisk • Fremont, CA

408d • $95,000 - $100,000

About The Position

The Sr. Associate - Quality Control in Cell Therapy at Novo Nordisk is responsible for performing day-to-day quality control activities in compliance with current cGMP and regulatory expectations for cell-based products. This role involves sample collection, testing, data analysis, and maintaining lab supplies to support the development of innovative therapies for chronic diseases such as Type 1 Diabetes.

Requirements

• Bachelor's Degree in Microbiology, Biology, Chemistry, Life Sciences, or related field required.
• 3+ years of relevant experience required (or 1 year with an advanced degree).
• Experience with Flow Cytometry required.
• Experience with cGMPs, USP/NF, EuPH, FDA guidelines, and ICH guidelines preferred.
• Experience writing standard operating procedures and cGMP documentation preferred.
• Experience in aseptic conduct and technique preferred.
• Experience with PCR assays preferred.
• Excellent organizational and multi-tasking skills, attention to detail, and adaptability to changing priorities required.
• Ability to handle conflicts and make decisions under time pressure required.

Nice To Haves

• Experience in the Pharmaceutical/Biotech industry preferred.
• Solutions-oriented mindset.

Responsibilities

• Perform non-GMP sampling and testing per protocol/SOP.
• Analyze, compile, and report data.
• Collaborate within QC and Analytical development on existing and new assays.
• Coordinate and ship samples to CRO.
• Perform GMP sampling and testing of Raw Materials, IPC, and product per SOP.
• Analyze, compile, review, and report data per GxP requirements.
• Write/revise documentation such as SOPs and training materials.
• Data entry and review in electronic systems (e.g., LIMs or PEMs).
• Support OOS, OOT, and Deviation investigation as needed.
• Order, stock, and inventory supplies for the lab.
• Coordinate with internal stakeholders on equipment calibration and qualification.
• Perform all job duties in a compliant and ethical manner.

Benefits

• Medical, dental, and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance
• Sick time policy
• Flexible vacation policy
• Parental leave policy

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree