Microbiology Engineer

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ResponsibilitiesResponsible for designing and setting up 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.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.Gain and maintain an overview of the manufacturing processes at the internal and external manufacturing sites and the differences in microbial control strategies. Foster platform alignment for microbial control of the manufacturing process and actively support related improvement activities at the manufacturing sites incl. taking the lead for CMC strategy approaches.Establish and lead 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.Coordinate and author microbiology summary risk assessments that includes the end-to-end Microbiology Control Strategy.Authoring of regulatory documents which require microbiology /endotoxin input and answering bioburden/endotoxin-specific questions from health authorities

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, e.g.;Requirements for pediatric patients (evaluate specific strategies for endotoxin and bioburden control and measurement).Requirements for primary packaging & solids handling (e.g.; zone concept, water equilibration, bulk storage, compounding at drug product manufacturing).Requirements for intrathecal applications.Provide technical guidance and technical oversight for CDMOs to build capability in executing routine tasks:Environmental monitoring sampling of manufacturing cleanroom areas and purified water systems with minimal supervision and direction to support the manufacture of commercial product support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing.Support laboratory investigations for out of trend (OOT) and out of specification (OOS) resultsSupport the authoring of deviation reports, test methods, and SOPs.Support accurately recording, summarize, trend and review microbiology data in accordance with cGMP and SOPs.Give guidance to personnel on microbiology sampling techniques and procedures.

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.Requirements Ph.D. or Master degree in Life Sciences (e.g.; Microbiology, Biotechnology or Chemistry)(5 years of professional experience in microbiology in a regulated environmentAdvanced knowledge in microbial analytical techniques and microbial control strategiesExperience as process expert and/or in GMP bio manufacturing would be advantageousStrong leadership skills and ability to lead/drive cross-functional teams (internally and at CDMOs). Some travel activity to be expected.High attention to detail and very good problem-solving skillsAbility 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 ambiguityFluency in English, German would be an advantage*Role can be based at our South San Francisco or Basel Headquarters. Full time