Sr. Technical Writer - Manufacturing Investigations

Job Description

We are seeking a Senior Technical Writer to support manufacturing and quality investigations for a cell therapy manufacturing program preparing for clinical and commercial scale up. This role will focus on authoring high quality, inspection ready investigation documentation in a fast paced, regulated environment with minimal ramp up time. The ideal candidate brings strong GMP investigation writing experience, a solid understanding of manufacturing and/or QC processes, and the ability to translate complex technical inputs into clear, compliant documentation without extensive training or oversight.

This is a highly execution focused role supporting a time sensitive manufacturing program.

Required Skills & Experience

•7–10+ years of experience in GMP regulated pharmaceutical or biotech manufacturing

• Demonstrated experience writing investigations (manufacturing deviations, OOS/OOT, CAPAs, impact assessments)

• Experience with structured investigation and root cause analysis tools (e.g., Fishbone/Ishikawa diagrams, 5 Whys).

• Strong working knowledge of GMP documentation practices and regulatory expectations

• Ability to step into an investigation workflow with minimal training or hand holding

• Experience supporting cell therapy, gene therapy, or biologics manufacturing

• Experience working in fast paced manufacturing environments with tight turnaround times

• Strong written communication skills — able to clearly articulate complex technical issues

Nice to Have Skills & Experience

•Prior work in CAR T manufacturing environments, strongly preferred.

Prior experience with Miltenyi Prodigy cell processing instrument.

• Familiarity with electronic batch records, LIMS, and quality systems

• Experience supporting manufacturing investigations at CMOs or external manufacturing sites

• Background in both manufacturing focused and analytical/QC investigations

Compensation:

$50/hr to $60/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.