Manager, Technical Services; MS&T

Overview

Headquartered in Nashville, TN – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). We provide a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, playing a vital role in the global pharmaceutical industry. We are investing capital in a two-phase expansion project, including a new state-of-the-art facility adjacent to our current site.

We offer dynamic opportunities, rewarding career paths, and a chance to make a difference in global health.

The Manager, Technical Services, will serve as a leader of a team responsible for process design and implementation by leading a Technical Operations team for establishment of new production processes in the GMP area. The primary focus will be to lead a team focused on New Product Introductions across late clinical and commercial programs. Technical understanding and application of current equipment, process controls, identification of support utilities and sampling technologies are important for development, optimization, and technology transfer of small and large molecule fill/finish operations.

The leader in this role will work with other Technical Services Managers to ensure good scientific collaboration and to balance resources for ongoing programs based on client and business needs. The leadership provided by this role is critical to the success of our client’s projects and to the growth of August Bioservices.

• Lead and manage an MS&T team to assure resources are applied appropriately in support of client project deliverables for New Product Introductions
• Work with R&D, Facilities and Validation teams to lead GMP process implementation based on the approved scope of work and with support from R&D team leads
• Lead customer facing discussions offering key opinions on elements of process design and implementation
• Oversee and manage client project schedules with awareness of interdepartmental action item dependencies and timing
• Accountable for Technical Services engineer team performance including “on-the-floor” support during feasibility, engineering and initial GMP campaigns
• Ensure appropriate stage-gate reviews and approvals for New Product Introductions following established SOPs
• Mentor and coach MS&T team members in areas of process development, ensuring adherence to New Product Introduction procedures
• Identify areas of capability gaps and recommend risk mitigation strategies related to client project execution, particularly in early to mid-clinical phases
• Review technology transfer documents to provide the technical analysis needed for the overall process
• Identify gaps in capabilities needed to support new product/process introductions and recommend solutions to close these gaps
• Lead evaluations of collected data during development and scale-up activities and identify critical process parameters and opportunities for optimization
• Lead training and familiarization efforts for new processes and equipment including development of operation SOPs and work instructions
• Lead and/or support execution of Toxicology, Clinical, Scale up, Exhibit/Registration manufacturing campaigns
• Support Commercial process Performance Qualification with production team inside production areas as required in conjunction with other Technical Services managers
• Offer input for the evaluation and selection of new equipment in support of fill/finish production operations in collaboration with client and internal stakeholders where required
• Participate in multidisciplinary project teams through the complete product transfer to support ongoing client projects on-time
• Conduct phase-specific studies based on DOE (Design of Experiments) as needed for formulation optimization and process confirmation
• Incorporate Quality-By-Design (QbD) in the product development program to improve drug formulation and manufacturing processes
• Investigations and Corrective Actions analysis and support
• Write comprehensive technical reports, business evaluations, process descriptions with or without supervision
• Write documents including master…