Senior Manufacturing Manager
DSJ Global is currently partner with a leading biopharmaceutical company in Austin, TX that is looking to add a Senior Manager of Manufacturing Technology to the team. This highly skilled and motivated professional will be responsible for leading GMP technical operations within manufacturing. This position will manage and oversee manufacturing readiness and compliance activities as it relates to receipt of tech transferred molecules, implementation of new technology, and closure of quality events within GMP Manufacturing.
Responsibilities:
- Manage the Manufacturing Technology team, responsible for manufacturing readiness and compliance related activities.
- Provide oversight of the Compliance team focused on authoring, reviewing, and approving investigations, CAPAs, SOPs, change controls, and batch records
- Lead cross-functional risk assessments, facility fit assessments, continuous improvement projects and other manufacturing readiness activities to support GMP operations
- Work with cross-functional teams to develop project timelines, charters, scope statements, project execution plans, and communication plans related to GMP operations. Provide regular updates to sponsors, stakeholders, and steering committees as needed.
- Work with Process Development to enable receipt of tech transfer and scale-up for new or modified biological processes
- Work with Supply Chain to create the Bill of Materials and to forecast raw materials and consumables required for upcoming GMP campaigns
- Identify and assist in introduction of new technologies and new equipment into GMP Manufacturing.
- Support manufacturing operations and ensure compliance with current corporate policies, regulatory guidelines, and safety practices
- Identify and implement process improvements, particularly for optimization, efficiency, and growth
Qualifications:
- B.S. in the Biological Sciences, Chemical/Biochemical Engineering, or related field with seven (7) years relevant experience, and master's degree preferred.
- 5+ years of relevant experience within a GMP manufacturing environment, a clean room environment, or a highly regulated environment is required
- Expert level experience and with fermentation and protein purification operations as well as with operation of manufacturing process equipment and automation is required.
- Prior experience successfully leading teams where personal and team accountability, attention to detail, collaboration, and business results were expected is required.
- Demonstrated ability to problem solve and provide solutions to challenges or obstacles.
