Quality Control Chemist

Payrate: $49.67 - $49.67/hr.

Method Transfer Lead (MTL), Scientist, is a QC expert within the QCSV group. This individual contributor has a good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.

• In order of importance, list the primary responsibilities critical to the performance of the position. Include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
• Support Project Lead for method transfer and/or validation internally and externally for assigned program(s).
• Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods.
• Plan and track method transfer and/or method validation deliverables.
• Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional representatives.
• Review method transfer and/or method validation assays, perform data verification, non‑routine data mining, and in‑depth data analysis.
• Represent QC in intra‑department project/initiative or cross‑functional teams in support of program and company goals.

• Bachelor’s degree in life science (post‑graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any related technical discipline.
• 8‑10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility.

• Expertise in designing and evaluating method validation and transfer studies including approaches such as partial re‑validation, co‑validation, and cross‑validation.
• Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
• Expert knowledge of scientific principles and expertise in mAb, biologics, vaccine, gene therapy, and the design and evaluation of study/experiment design.
• Good mindset and technical skills for analytical methods and plate‑based methods; experience in analytical separation methods (SEC, icIEF, CE‑SDS) is preferred but not required.
• Good project management skills and experience managing multiple projects at the same time.
• Strong data interpretation, method troubleshooting skills, and sound scientific judgement.
• Good time management skills with attention to detail and desire to achieve team and individual goals.
• Excellent communication skills to lead a team and influence other leaders or cross‑functional team members.
• Understanding of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission such as IND, IMPD, BLA or NDA, etc.

The typical base pay for this role across the U.S. is: $49.67 - $49.67/hr final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full‑time employees are eligible to select from different benefits packages, which may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.