Manager, Process Engineering (Dsp)

About the Position: The network of Patheon's drug substance manufacturing sites includes St. Louis, USA, Groningen, Netherlands, and Brisbane, Australia. The performance of each manufacturing site is closely linked to the timely introduction of new projects, right-first-time manufacturing, and on-time delivery of products to customers. As you lead the DSP Process Engineering team responsible for the successful transfer of new projects, you will train and mentor staff, drive harmonization, assist with global projects, and address major site deviations/issues. The successful candidate will be a highly motivated self-starter who can assimilate new information quickly and enjoys cross-department collaboration within a fast-paced project execution environment. Responsibilities: Ensure DSP PE team delivers on all performance metrics for the site and network. Develop and mentor Process and Support Engineers. Coordinate technology transfer, facility fit, and implementation of NPIs along with PPQ and commercial DSP processes working with internal development teams and external clients to ensure successful operational execution. Lead hands-on problem-solving efforts and root cause investigations to resolve deviations related to equipment, process, or product and communicate the outcome of any investigation to internal and external customers. Provide direction to the development sites regarding the facility-fit of new processes and technical expertise for manufacturing scale processes across the Patheon network. Support late-phase process validation programs including Process Characterization (PC), Risk Assessments, and Control Strategy. Identify improvements and share best practices across the network. Generate, review, and approve GMP documentation including Standard Operating Procedures (SOPs), Technical Transfer documents, Master Batch Records, Process Flow Diagrams, and Bill of Materials. Implement new technology and equipment within the production facility. Requirements: Education: Tertiary degree in Science or Engineering (preferably in biology, biotechnology, biochemistry, chemistry). Experience: Previous management experience is preferable. More than 5 years in a biopharmaceutical GMP manufacturing environment or a Process Development lab/pilot plant. Skills & Attributes: Strong analytical and problem-solving skills. Ability to work in a matrix management system and influence and negotiate without direct authority. Effective planning, resource, and time management skills. Strong interpersonal and communications skills; written and oral, and a demonstrated decision-making ability. Proficient with IT systems including applications such as MS Office, Project and knowledge of controlled documentation and data systems. Experience with automation an advantage. Benefits: A competitive salary and performance-related bonus structure. Access to Thermo Fisher's global University. Development opportunities as part of a rapidly growing global organization. Other Job Requirements: Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. #J-18808-Ljbffr