August Bioservices is seeking a Manager, Technical Services (MS&T) to lead a team responsible for process design and implementation, new product introductions, and technical operations. The ideal candidate will have a B.S in Pharmaceutical Sciences or equivalent and leadership experience in pharmaceutical processing technologies.
Requirements
- Lead and manage an MS&T team
- Work with R&D, Facilities, and Validation team to lead GMP process implementation
- Leads customer-facing discussions on process design and implementation
- Active oversight and accountability of client project schedules
- Accountable for Technical Services Engineer team performance
- Mentor and coach MS&T team members
- Identify areas of capability gaps and recommend risk mitigation strategies
- Review technology transfer documents and identify gaps in capabilities
- Lead evaluations of collected data and recommend critical process parameters
- Lead training and familiarization efforts for new processes and equipment
- Lead execution of Toxicology, Clinical, Scale-up, Exhibit/Registration manufacturing campaigns
- Support Commercial process Performance Qualification
- Offer key opinion for equipment evaluation and selection
- Participate in multidisciplinary project teams
- Conduct phase-specific studies based on DOE
- Incorporate Quality-By-Design approach in product development program
- Investigations and Corrective Actions analysis and support
- Write comprehensive technical reports and documents
- Troubleshoot and resolve technical issues
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Relocation Assistance