Technical Writer - Cell Therapy Vector Support (MSAT)

Job Title : Technical Writer - Cell Therapy Vector Support (MSAT)

Location : Libertyville, IL (50% onsite)

Our client is seeking a dedicated and meticulous Technical Writer for Cellular Therapy Vector Support within the Manufacturing Science and Technology (MSAT) department.

This role is integral to our client's mission of delivering innovative cell therapy solutions. The successful candidate will be responsible for investigating and documenting root cause analyses for non-conformance events during cell therapy vector manufacturing, thereby ensuring the highest standards of quality and safety.

Key Responsibilities :

• Conduct thorough investigations into non-conformance events during the manufacturing process of cell therapy vectors and document the root cause analyses.
• Compile, analyze, and interpret manufacturing process data to identify potential failure modes, contributing to the continuous improvement of our client's manufacturing processes.
• Apply complex cell biology concepts to root cause investigations, demonstrating a deep understanding of the science behind our client's products.
• Collaborate closely with Process Engineers to gain a comprehensive understanding of different failure modes, fostering a culture of knowledge sharing and teamwork.
• Work in conjunction with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports, ensuring compliance with all relevant regulations and standards.

Required Qualifications and Skills :

• A Bachelor's degree in Bio / Chem Science / Engineering or a related field. An educational background in Immunology is preferred.
• A minimum of three years of relevant experience in the biopharmaceutical industry, specifically in drug product manufacturing.
• Proficiency in deviation writing and a solid understanding of cGMP / cGDP.
• Strong scientific and technical acumen, including exceptional technical writing skills.
• The ability to prioritize multiple investigations to meet strict deadlines.
• Experience with Quality Management Systems.
• Complex problem-solving skills, including experience in root cause investigation.
• Proven ability to collaborate cross-functionally with engineering and quality partners.
• Experience in Biologics or cell therapy manufacturing.

About SSi People :

With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.

Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly.

More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.