Technical Writer (Scientific/Medical) - Downstream Processing

About Rentschler Biopharma

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with 1,000 employees.

Job Summary

This Medical/Scientific Writer position is in the Downstream Process Development group. The person in this role will be responsible for the preparation and review of scientific reports out of the Process Science groups. Additionally, this person will contribute in a cross functional capacity by authoring or assisting with policies, SOPs, protocols, and batch records.

Duties and Responsibilities

• Analysis of raw process and analytical data related to downstream process development
• Preparation and review of scientific reports out of the Process Science groups
• Preparation and review of general documents (Policies, SOPs)
• Preparation and review of cGMP documents (Protocols, Reports, Batch Records)
• Active contribution in internal projects (i.e., standardization of documents/graphs/templates)
• Support for preparation of presentations and posters
• Support for preparation of general documentation work

Qualifications

• Master’s degree or relevant experience in biotechnology, biochemistry, or a comparable scientific/technical field
• Advanced ability with Microsoft Office – Outlook, Word, Excel, PowerPoint
• Demonstrates an ability to depict or present complex scientific data in a comprehensible way
• Advanced knowledge in biotechnical manufacturing processes is a plus
• Basic knowledge in presentation and communication techniques
• Basic understanding of biostatistics
• Should be detail oriented regarding grammar, orthography, scientific precision and taxonomy, layout, and design
• Basic knowledge in project management
• 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

• 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

Direct Reports