Augustbioservices4mo ago

Manager, Technical Services (MS&T)

United States·NashvilleFull-Timemid

OtherManager

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Overview

Technical Tools

ms-office

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.

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.

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.