Engineer, Microbiology

Job Responsibilities

General

• Be the link between the technical development project teams, the related contract development and manufacturing organizations (CDMOs) and the microbiology experts (SMEs) in the network for end-to-end strategic microbial oversight. Define Roche requirements for microbial control at CDMOs. Support CDMOs in improving respective capabilities, rate CDMOs and support CDMO selection based on their capabilities to follow Roche requirements.
• Responsible for designing and coordinating the end-to-end Microbiology (Bioburden, Sterility, and Endotoxins) Control Strategy and Sterility Assurance (incl engineering and aseptic processing controls) for clinical and PPQ campaigns for all synthetic molecules (small molecules, oligonucleotides, peptides) for parenteral administration. Ensure that control strategy aspects are already considered during process development.
• Support a cross-functional Microbiology expert (sub) team and act as a single point of contact for all Microbiology related topics and activities in the technical development teams.
• Assess and optimize manufacturing and sampling processes, used equipment and utilities for microbiology control manufactured within Roche and at CDMOs. This includes:
  • Provide guidance to optimize manufacturing process to minimize microbial risks Support for deviations and changes with potential microbiology impact and give guidance on CAPAs.
  • Support microbiology troubleshooting (e.g.; unexpected open handling during UF, additional sampling due to rupture of bags) and support root cause investigations in case of high bioburden results.
  • Review of Bioburden/Endotoxin IPC results and the related technical development reports. Provide guidance/recommendations on further preventive measures and control points, if needed.
  • Authoring Case by Case Assessment (CCAB) in case of Bioburden excursion above action limit.
• Support technical functions and CDMOs in microbiology questions, including technical guidance and oversight for:
  • Environmental monitoring sampling of CMO suites
  • Laboratory investigations for OOT and OOS results
  • Accurately recording, summarize, trend and review microbiology data in accordance with cGMP and SOPs.
• Build up and maintain a network of microbiology experts, and foster the collaboration within this network.
• Maintain and expand knowledge related to microbiological, process, equipment and manufacturing aspects within the project team.
• Transfer knowledge into the project teams to enable project teams to handle routine microbial task independently.

Qualifications & Experience

• At a minimum >5 years of professional experience in microbiology in a regulated environment:
• B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 6+ years of experience in the pharmaceutical or biotechnology industry -OR-
• M.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 4+ years of experience - OR-
• PhD in Life Sciences (Microbiology, Biotechnology or Chemistry) or Engineering or related field with 2+ years of experience
• Advanced knowledge in microbial control strategies and experience as process expert and/or in GMP bio manufacturing is a plus.

Interpersonal Skills:

• Advanced knowledge in microbial control strategies and experience as process expert and/or in GMP bio manufacturing is a plus.
• Strong leadership skills and ability to lead/drive cross-functional teams (internally and at CDMOs).
• High attention to detail and very good problem-solving skills
• Ability to navigate in a complex global matrix organization, collaborate and engage with various hierarchy.levels and influence decision-making without formal authority including senior management.
• Being an effective communicator with the ability to deal with ambiguity.
• Fluency in English, German would be an advantage

Some travel activity to be expected.

• Roche is an equal opportunity employer

*Role can be based at our South San Francisco or Basel Headquarters.