Scientific Technical Writer (Analytical Method Validation)

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

Duties And Responsibilities

• Review and evaluate method validation data in accordance with ICH and other method validation guidelines
• Preparation and review of cGMP method validation/qualification protocols and reports out of the Quality Control Analytical Development group
• Preparation, design, and/or review of general Quality Control documents (Test Procedures, SOPs, Assay forms, Document Templates)
• Collaborate with cross-functional teams to ensure that documents are prepared and reviewed in a timely manner
• Continuously improve method validation documentation and procedural workflows
• Other technical writing may be required such as Change Controls, comparability reports, Laboratory Investigation Reports, QC technical reports, and other technical writing tasks as assigned

Qualifications

• Degree in Biochemistry, Molecular Biology or equivalent STEM degree
• Years of experience and education (one of the following):
• Bachelors degree and 8 years of related experience
• Masters degree and 5 years
• PhD and 3 years of experience
• Strong experience with method validation and method transfers for biological products
• Maintain expertise in method validation requirements with a focus ICH Q2R2 Validation of Analytical procedures. Interpretation of country specific guidelines may be required based on project needs
• Experience with and technical understanding of multiple assay types including but not limited to Chromatography (RP-HPLC, IEX-HPLC, SE-HPLC, etc.), ELISAs, Capillary Electrophoresis, N-Glycan and peptide mapping analysis
• Demonstrates the ability to depict or present complex scientific data clearly and concisely
• Knowledge in biotechnical manufacturing processes as well as current GMP regulations, guidance documents, and industry best practices
• Understanding of statistical evaluation of analytical data
• Proficient with Microsoft Office – Outlook, Word, Excel, PowerPoint
• Should be detail oriented regarding grammar, orthography, scientific precision and taxonomy, layout, and design
• The candidate should be self-motivated, accountable, and have excellent organization skills
• Entrepreneurial mindset, economic and analytical thinking
• Strong and collaborative communication skills, team spirit, flexibility, and be outcome-oriented

Working Conditions

• Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipment:
• Compliance with Personal Protective Equipment, clean room gowning, and EH&S requirements when appropriate/required
• Normal office working conditions: computer, phone, files, copier
• Will interact with other people
• Pace may be fast and job completion demands may be high

Physical Requirements

• PPE as required