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Rentschler Biopharma · 2 days ago

Scientific Technical Writer (Analytical Method Validation)

Milford, MA

Full-time

Onsite

Senior Level

5+ years exp

Rentschler Biopharma is a leading contract development and manufacturing organization focused on biopharmaceuticals. They are seeking a Scientific Technical Writer to review and evaluate method validation data, prepare and review quality control documents, and collaborate with cross-functional teams to ensure timely documentation.

BiopharmaBiotechnologyManufacturing

H1B Sponsor Likely

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

Qualification

Method validationBiological productsAnalytical proceduresChromatographyStatistical evaluationGMP regulationsTechnical writingMicrosoft OfficeDetail orientedOrganizational skillsCommunication skills

Required

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

Company

Rentschler Biopharma

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects.

Founded in 2006

Laupheim, Baden-Wurttemberg, DEU

1001-5000 employees

https://www.rentschler-biopharma.com

H1B Sponsorship

Rentschler Biopharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (4)

2024 (1)

2023 (4)

2021 (2)