Manager, Sterile DP Manufacturing Operations
Having just obtained approval to establish internal Sterile Drug Product Filling operations at the Shanbally site, we at BioMarin are now looking to commence hiring for key technical and leadership positions. Initially these roles will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.
Reporting to the Director, Sterile DP Manufacturing Operations, the primary role of the Sterile DP Manufacturing Operations Manager is to establish and lead the sterile filling operations team through successful operational readiness and start up activities including; hiring technicians, writing SOPs and batch records, attendance at FATs, running engineering and media fills, GMP certification and execution of PQ fills.
Once operational readiness efforts are complete it is expected the Sterile DP Manufacturing Operations Manager will deliver day to day manufacturing requirements by leading a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant manufacture of sterile Drug Product material. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.
The Sterile DP Manufacturing Operations Manager will report to the Director, Sterile DP Manufacturing Operations.
- Lead and support the Sterile filling team in the production of drug product under cGMP conditions.
- Hire the sterile filling team and lead the development in areas of technical expertise, and coach and mentor high performance team behaviours.
- Represent the Operations team through the construction project, C&Q, technical transfer activities, process validation and site regulatory inspections.
- Provide on-floor technical support and troubleshooting
- Participate in budget planning and headcount planning. Communicate capital equipment needs, facility needs, team needs; and contract service requirements
- Influence, support and partner closely with sterile DP technical services, process engineers, Biotechnicians and other colleagues to ensure master batch records, SOPs and other documents are generated and maintained as current and compliant under cGMP conditions – ensure manufacturing systems and practices are consistent throughout the organization.
- Lead, coach and support daily operation of sterile filling and visual inspection equipment and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration.
- Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
- Lead and demonstrate strong stakeholder management in terms of interfacing with other BioMarin departments (Regulatory Affairs, Quality control, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Demonstrated experience with the execution of Technology Transfer and scale up programs for commercial drug product manufacturing processes.
- Oversee the MFG inspection readiness program and ensure MFG colleagues are audit ready
- Develop and demonstrate a proactive approach to safety, industrial hygiene, environmental and regulatory compliance
- Bachelor degree in biotechnology, chemical or biochemical engineering or related field with a minimum of 5 years supervisory/management experience with a strong technical knowledge of sterile manufacturing technology and processing techniques is required
Work Environment / Physical Demands
This would arise from time spent primarily at equipment manufacturers for design, engineering runs and FATs. Other travel would include the BioMarin facilities in Marin County, US.
- Degree in Science / Engineering, Operations Management, Industrial Engineering or related field required
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
- At least 5 years GMP/GCP compliant Biopharma operations experience required
- 5 years of directly related experience in aseptic drug product manufacturing environment.
- Past experience and demonstrated ability to successfully influence team performance is strongly preferred.
- Strong demonstrated ability in the area of communication and strong ability to interact within cross-functional teams.
- Demonstrated ability coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections and direct interaction with regulatory inspectors.
- Highly developed organizational and leadership skills.
- Process development and/or technology transfer experience preferred.
- Track record of embedding a strong Quality culture.
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
- Creative problem solving skills
- Comfortable and effective working indirectly through others
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.