Manager, Technical Services - Nashville - August Bioservices

Description

Headquartered in Nashville, TN - one of the fastest-growing and most exciting cities in the United States - August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project - including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August
The Manager, Technical Services, will serve as a leader of a team responsible for process design and implementation by leading a Technical Operations team responsible for establishment of new production processes into 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 is an important competency as they relate to development, optimization, and technology transfer of small and large molecule fill/finish operations. The leader in the role will work with other Technical Services Managers to assure good scientific collaboration is promoted and resources for ongoing programs are balanced 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.
Responsibilities

• 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 team to lead GMP process implementation based on the approved scope of work and with support from R&D team leads
• Leads customer facing discussions offering key opinion on elements of process design and implementation
• Active oversight and accountability of client project schedules with awareness for 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
• Accountable for appropriate stage-gate review and approval for New Product Introductions following established SOP's
• Mentor and coach MS&T team members in areas of process development assuring adherence to New Product Introduction procedures
• Identify areas of capability gaps and recommendation of risk mitigation strategies related to client project execution particularly in early to mid-clinical phases
• Review of technology transfer documents such as product development reports, batch manufacturing and/or packaging records to provide the technical analysis needed for the overall process.
• Based on analysis, 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 recommend critical process parameters and opportunities for process optimization
• Lead training and familiarization efforts for new processes and equipment including development of operation SOP and work instructions
• Lead and/or support execution of Toxicology, Clinical, Scale up, Exhibit/Registration manufacturing campaigns
• Supports Commercial process Performance Qualification with production team inside production areas as required in conjunction with other Technical Services managers
• Offers key opinion 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) approach in the product development program to improve the drug formulation and manufacturing process.
• Investigations and Corrective Actions analysis and support.
• Write comprehensive technical reports, business evaluations, process description with or without supervision.
• Write documents including master batch records, protocols and reports, SOPs, Work Instructions, and other necessary technical documents.
• Troubleshoot and resolve simple to moderately complex issues, diagnosing technical problems and identifying short and long-term solutions
• Working with Cross-Functional Team leads to identifying opportunities for enhancements and champion projects which will improve overall site function.
• Proficient in Quality system software such as Master control and related task such MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents.

Qualifications and Skills

• B.S in Pharmaceutical Sciences (or equivalent), M.S in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent).
• Team leadership skills for effective deployment of departmental resources
• Knowledge of High-Pressure Homogenization, Rotary Evaporators, High Shear Homogenizers, Microfluidizers, Extrusion, Lyophilization, PFS, Vial filling operations, etc.
• Knowledge of pharmaceutical processing technologies such as mixers, transfer pumps, temperature control devices
• Knowledge of appropriate process requirements for sterile operations including: compounding, sterile filtration, aseptic formulation, sterile filling for vials, pre-filled syringes and flexible IV bags
• Software
• Minitab (or equivalent), Microsoft Office etc.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule - from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.