Manufacturing Technical Writer (6+ Month Contract)
Rentschler Biopharma
Summary
The Manufacturing Technical Writer will be responsible for creating, revising, editing GMP documentation such as manufacturing batch records, SOPs and work instructions.
Job description
Duties and Responsibilities
- Generate, revise, and manage Upstream Master Production Records (MPRs) and associated GMP documentation, including batch records, SOPs, and work instructions, ensuring accuracy, compliance, and on-time implementation.
- Serve as the documentation lead for upstream manufacturing processes, utilizing knowledge of cell culture operations, subcultivation, perfusion, and single-use bioreactor systems to develop and maintain manufacturing instructions.
- Own document workflows within quality systems, including document creation, routing, review, approval, revision control, and implementation activities.
- Partner with Manufacturing Operations, MSAT, Process Engineering, Quality, and Training teams to ensure documentation is completed on schedule, assigned to the appropriate departments, and supported by the appropriate training strategy.
Qualifications
- Bachelor’s Degrees is required
- Biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- 5+ years’ experience in manufacturing, quality & compliance (Clinical, Commercial, Medical Device, MedTech)
- Author of GMP and technical documentation for new and existing processes; Process technical documents, Manufacturing description documents, SOPs, Batch records, Solution records and Training documents
- Experienced with user role in quality documentation systems such as Master control and/or Track wise
- Self-initiator, strong collaborator, proven dot connector, results driven, ability to clearly track work status and communicate to relevant departments, strong capability to resolve challenges to meet deadlines
Working Conditions
- Lab environment
- Office environment
Physical Requirements
- PPE as required
Requirements
- Bachelor’s Degree is required
- Biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- 5+ years’ experience in manufacturing, quality & compliance (Clinical, Commercial, Medical Device, MedTech)
- Author of GMP and technical documentation for new and existing processes; Process technical documents, Manufacturing description documents, SOPs, Batch records, Solution records and Training documents
- Experienced with user role in quality documentation systems such as Master control and/or Track wise
- Self-initiator, strong collaborator, proven dot connector, results driven, ability to clearly track work status and communicate to relevant departments, strong capability to resolve challenges to meet deadlines
Benefits
- Annual discretionary bonus program
- Medical insurance
- 401K program
- Professional wellness support
Company overview
Rentschler Biopharma is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services. Founded in 1872 and now in its fifth generation as a family-owned company, Rentschler Biopharma has over 50 years of experience in biopharmaceutical manufacturing. The company operates from two main sites: its headquarters in Laupheim, Germany, and a facility in Milford, Massachusetts, USA. With approximately 1,400 employees, Rentschler Biopharma offers comprehensive full-service solutions for bioprocess development and manufacturing of complex biopharmaceuticals, including analytical development, process development, formulation development, cGMP manufacturing, and regulatory affairs consulting. The company has an impressive track record, having contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023 and serving over 180 clients worldwide since 1997. Rentschler Biopharma specializes in complex molecules, with more than 50% of their modalities being complex proteins including advanced antibody formats and recombinant enzymes. The company is known for its reliability, quality management systems, and operational excellence philosophy that ensures product quality and productivity at every development and manufacturing stage.