QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• MS degree 3+ years’ experience, or a BS degree and 6+ years’ experience in a relevant discipline (cell biology, biotechnology, or related field) in the pharmaceutical industry.
• Experience with biological products is critical, experience within cell therapy is required.
• Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP).
• Strong knowledge of GMP stability program including protocol design and shelf-life assignment.
• Experience within a QC pharmaceutical laboratory.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Demonstrated proficiency in stability studies in a GMP environment and QC setting.
• Ability to work cross-functionally with excellent verbal communication and collaboration skills.
• Quality mindset with demonstrated ability to identify compliance gaps.
• Proficient use of MS Office products.
• Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
• Ability to work effectively both independently and with other team members.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

KEY RESPONSIBILITIES

• Works with external QC laboratories to review and track GMP in process, stability and release testing.
• Real time review of DP release data during harvests and generate CoAs as part of a rapid release strategy.
• Supports design of DS and DP stability studies, leading to establishment of expiry. This includes protocol review, data review, and report review in collaboration with an external CMO.
• Supports technology transfers, method validations, and method qualifications through data and document review.
• Participates in internal and external collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven decisions.
• Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• MS degree 3+ years’ experience, or a BS degree and 6+ years’ experience in a relevant discipline (cell biology, biotechnology, or related field) in the pharmaceutical industry.
• Experience with biological products is critical, experience within cell therapy is required.
• Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP).
• Strong knowledge of GMP stability program including protocol design and shelf-life assignment.
• Experience within a QC pharmaceutical laboratory