Senior Engineer, Downstream MSAT

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

• Lead Technology transfer of client products working closely in collaboration with process development, Manufacturing, Engineering and Quality
• Partner with Process Science to ensure the design and scale up of processes, instruments, and equipment from the laboratory through pilot scale are executable by manufacturing operations when moving into full scale manufacturing
• Partner with manufacturing to ensure that manufacturing operations are designed for success ensuring high quality batch records, robust processes, and new technology
• Anticipate, respond to, and resolve issues that arise on the floor in production through use of master data, process, and product monitoring
• Utilize MSAT team’s technical skills and process knowledge to participate and/or lead process investigations through to root cause determination. Collaborate within the organization to develop and execute effective CAPA
• Proactively drive Process Performance Qualification together with MSAT USP, Process Science, Regulatory, Manufacturing, Validation and Quality
• Leads process monitoring and control of manufacturing processes and continuous improvement programs
• Provide troubleshooting, technical support and training on the shop floor
• Regularly interact with Rentschler senior management and clients. Interactions involve use of influencing, conflict resolution and balancing the interests of the clients with those of Rentschler
• Work closely with clients to ensure that their projects are executed successfully through the transfer, implementation, validation, filing and licensing of their products
• Partner with MSAT network teams and peers to share and adopt best practices and drive continuous improvement in all technical aspects of production
• Support the business development function by providing technical expertise for Process facility fit evaluations and responses for RFPs
• Responsible for authoring technical reports, manufacturing instructions, process validation documents and portions of regulatory submissions to support licensing client products and process changes
• Support regulatory filings and responses to health authority questions. Author and review CMC sections for IND and BLA submissions

Qualifications

• Bachelor’s degree in STEM
• 5 years of related experience
• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
• Experience with biologics drug substance process development and/or manufacturing operations
• Experience in process transfer in and manufacturing technical operations
• Experience leading process technology transfers for clinical or commercial biologic(s)
• Experience with Quality systems such as Deviation, CAPA, Change Control systems
• Escalate and resolve project issues/ roadblocks as appropriate
• Ability to identify and resolve complex technical issues including quality investigations
• Advanced proficiency with Microsoft Office

Preferred Qualifications

• Previous experience in a Contract Development Manufacturing Organization (CDMO) environment
• Experience in process qualification/validation (PPQ) and/or continued process verification (CPV).
• Unicorn, JMP, and MODDE

Working Conditions

• Normal office working conditions: computer, phone, files, fax, copier
• Personal Protective Equipment must be worn as required