This role will support manufacturing operations at Contract sites (CMOs, CDMOs). It involves on-site person-in-plant oversight of manufacturing and leveraging technical skills for process scale-up, technology transfers and more!
- Provide technical operations expertise in the areas of aseptic fill/finish and tech transfer of drug product
- Responsible for a wide range of activities such as project management associated to the execution of clinical / commercial drug product manufacturing
- Support and manage the day-to-day manufacturing activities to ensure drug product clinical and commercial supply
- Direct interaction with contract site management, includes being on-site at CMOs and hands-on person-in-plant oversight activities
- Technical review of Engineering and GMP batch records, draft and executed validation protocols and reports, work instructions, SOPs, or other required documents for cGMP operations
- Helps with logistics and planning activities such as proposals, quotes, invoices, and shipping
- Frequently interacts with other functional peer group managers and CMOs to support the development or manufacturing activities
- Support the operations within the Technical Operations Department such as production planning, scheduling, and inventory management.
- Support any routine and nonroutine cGMP activities, deviations, investigations, CAPAs, process improvements, change control technical assessment, shelf-life extensions, etc.
- Ensure business objectives while meeting quality and compliance standards
- Collaborate with other departments on any DOE or QbD activities
- Track invoice approvals and proactively verify versus work performed.
- Bachelor's/Master's degree required in relevant Life Sciences, Scientific, Pharmaceutical Sciences, Pharmaceutical Engineer, Chemical Engineer, or related field
- Minimum 7+ of experience in a GMP global pharmaceutical / biotech environment with sterile drug product manufacturing and development
- Experience with peptides, small molecules, biologicals, and aseptic processes
- Knowledge of cGMP regulations for process validation and continuous improvement programs
- Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and managing third party CMO relationships
- Must have strong computer skills, including all MS Office applications
- Competencies: Strong Project Management skills, Leadership skills, Team Oriented, Self-directed, Multi-tasker, Attention to Detail, Interpersonal skills, Written and Verbal Communication, Negotiation, Problem-Solving, Time Management, and Organizational skills
- Working Conditions: Position may require periodic evening / weekend work, and periodic overnight travel, as necessary to fulfill obligations. Travel may be required up to 25% at times to CMOs locations.