Scientist, Upstream Process Development

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

Duties And Responsibilities

• Development of scale-able and robust upstream processes including process characterization, and/or technology transfer to clinical and commercial GMP manufacturing while meeting the project deliverables
• Use QbD principles to design and execute experiments related to development, optimization, and scale down/ scale-up of all mammalian cell culture unit operations utilizing shake flasks, high-throughput AMBR systems, and bench scale to 200L pilot scale bioreactors.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
• Ability to work in a team environment and drive the success of the team
• Apply advanced statistical techniques to design experiments related to process development and characterization
• Author high-quality documents, including technical reports, SOPs, and experimental protocols
• Serve as a Process Development representative and participate in cross functional meetings
• Contribute to scale up activities and draft technical transfer related documents (e.g. process description, process flow diagram)
• Review batch records and provide comments
• Support MFG floor activities and process deviations including effective CAPAs.
• Provide technical support (e.g. process/operational gap identification and troubleshooting) to MSAT and the manufacturing group
• Compile and present data at client project teams and author reports
• Contribute to the overall operations of process sciences lab and infrastructure improvements
• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
• Train and/or lead Associate Scientists

Qualifications

• A university degree and 5 years of related experience
• A Master’s degree and 3 years
• A PhD and 1 years(s) of experience
• Solid theoretical knowledge and hands-on experience cell culture process development, including aseptic technique and bioreactor operation.
• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
• Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)
• Demonstrates ability to work both independently and as a member of local / global teams
• Excellent customer service skills and ability to meet client project deadlines
• Flexibility of hours to support laboratory and MFG floor activities. Weekend and holiday hours are compensated per HR company policies
• Flexibility to switch between projects
• Specific experience with the following:
• Creating cell banks
• Developing depth filtration and disc stack harvest unit operations
• Proficiency in programming and operating the AMBR 250 high-throughput bioreactor system
• Use of statistical tools such as JMP or MODDE
• Familiarity with ICH guidelines
• Process characterization using QbD principles

Working Conditions

• Laboratory environment working with chemical reagents and genetically modified cells
• Personal Protective Equipment must be worn as required.
• Normal office working conditions: computer, phone, files, fax, copier.
• Will interact with other people
• Pace may be fast and job completion demands may be high.

Physical Requirements

• PPE as required
• Frequent lifting up to 10 lbs.
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to use computer.