A large biotechnology company in Frederick Maryland is looking for a hybrid Product Quality Lead to join their team. This company develops cancer immunotherapy products with a primary focus on cell therapy based solutions.

This senior level technical expert will provide product quality support that focuses on regulatory writing of BLA sections for a fast-moving clinical CAR-T program. This person will work cross functionally with teams to lead the approval process of the BLA from start to finish. Responsibilities include following up on project deliverables, performing data verification, participating in technical discussions with cross functional team members that include process development, MSAT, QA/QC, Global QC, Compliance. This person will lead focused teams to resolve issues and keep the program on track from a Quality perspective.

Must Haves:

-Bachelors degree (Scientific degree) - analytical testing, talk in detail and technical

-5 years of experience leading complex Quality projects within Biotech (product quality leader, or quality control experience in the lab, strong technical knowledge)

-Analytical testing background

-Knowledge of BLAs

-Strong technical writing skills

-Experience working in regulatory writing systems

Plusses:

-Masters degree in a science related field

-Car-t QA/QC experience preferred (Car-t analytical testing skills)

-Change control experience

-Experience getting a BLA filed in the past, or writing them

Hybrid - 3 days a week at the Frederick Maryland Facility

Remote EST only (flexible not guaranteed)

Compensation & Benefits:

$60/hr to $80/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.