Director, MSAT (Drug Product)
Roche
Summary
We're seeking a highly experienced and strategic MSAT Process Engineering Lead to manage a group of engineers through process design, qualification, startup and registration at our state-of-the-art manufacturing site. This position will oversee the process aspects of Compounding/Formulation/Filling/Inspection of sterile drug product, which will then be assembled and packaged into autoinjectors and multi-dose pens. This is a key role in site management to develop the process engineering staff to be interface to global technology implementation and development interfaces, as well as play a key role for developing the regulatory filing and approval strategy alongside the global and site functions.
Job description
What you'll do
- Provide clear objectives, coaching, and continued development opportunities to direct reports
- Support project leadership and co-lead project teams to ensure processes meet cGMP/regulatory requirements
- Provide technical expertise and input on design and implementation of production equipment
- Ensure implementation of quality systems and SOPs for tech transfer, filter validation, process validation, mixing characterization, leachable/extractables, aseptic simulations, and cleaning validations
- Ensure processes transferred meet characterization expectations for critical and key process parameters
- Ensure proper implementation of process and microbial control strategies
- Design and execute studies and comparability protocols
- Perform cross-functional risk assessments for process controls
- Ensure PPQ pre-requisites are met for site start up and launch
- Participate in creation, review, and approval of regulatory dossier sections for site licensure
- Provide input to strategic and streamlined approaches for validation activities
- Ensure appropriate specifications for direct raw materials and process IPCs and outputs
- Foster a positive safety culture and ensure SHE guidelines are followed
- Contribute to continued improvements to OEE and process COGS
- Ensure business continuity risk assessments are conducted
- Provide knowledge and training on complex process and equipment technologies
- Act as a coach for colleagues with less experience
Who you are
- Bachelor's, Master's, or Ph.D. degree in bio/chemical engineering or similar
- 12+ years experience in technology of pharmaceutical industry
- Minimum of 5 years of people management experience
- Recognized expert in drug product manufacturing relevant unit operations (Compounding, Filling, Inspection)
- Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections
- Up-to-date knowledge of cGMP's, Health Authority regulations, and Quality Systems
Preferred
- Relevant experience in data science/engineering, analytics to drive smart factory concept
- Ability to organize and solve complex, unique or unprecedented problems
- Advanced project management skills: technology implementation and start-up
- Relevant contact with collaborators, regulatory agencies, and vendors
- Ability to advise and influence senior management on advanced technical matters
Work Environment/Safety Considerations
- This role requires full onsite work at the project office before transitioning to the site offices
- Ability to work in an international/global environment
- Domestic and international travel required. Travel up to 20% after full relocation
- May work in clean room environment requiring gowning (hospital scrubs, bunny suits, gloves, steel toe boots)
Requirements
- Bachelor's, Master's, or Ph.D. degree in bio/chemical engineering or similar
- 12+ years experience in technology of pharmaceutical industry
- Minimum of 5 years of people management experience
- Recognized expert in drug product manufacturing relevant unit operations (Compounding, Filling, Inspection)
- Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections
- Up-to-date knowledge of cGMP's, Health Authority regulations, and Quality Systems
Benefits
- Relocation benefits
- Discretionary annual bonus
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.