MTS Manager

PCI Pharma Services•Madison, WI

About The Position

The Manufacturing Science and Technology (MTS) department maintains manufacturing process knowledge and supports or drives development and technical transfer of new technologies and manufacturing processes. Its work includes developing batch records, ensuring manufacturing operations align with client-specified processes, and supporting technical investigations and improvement projects to mitigate manufacturing non-conformances and enhance productivity. The MTS Manager reports to the General Manager and leads the MTS Engineering and Specialist Team, providing technical management and professional development. The role collaborates with Project Management, Process Development, Validation, Quality Control, Quality, Safety, and Manufacturing teams. The Manager provides technical support to internal stakeholders and external clients, including guidance on technical writing and decision-making for client project deliverables, and ensures work is completed in a timely manner.

Requirements

At least 8 years of technical experience in Life Sciences (Biopharmaceutical/Biotechnology), Medical Device, or Aseptic Manufacturing, with GMP industry experience.
Hands-on experience in Process Engineering/Sciences, Manufacturing Operations, or Technical Project Management.
Prior people-management experience, with supervisory experience at a minimum.
Experience leading and driving projects to completion.
Experience managing GMP manufacturing projects involving investigations, change control, process optimization, technical transfer, process troubleshooting, batch record implementation, and improvement of GMP manufacturing operations.
Ability to manage MTS engineers and specialists through coaching, career development, and building a motivated, high-performing, engaged, and effective team.
Full understanding of cGMPs, regulatory compliance, and safety regulations.
Understanding of scientific principles related to GMP processing and experimental design.

Nice To Haves

Prior lyophilization experience.
Experience in a biopharmaceutical or medical device manufacturing organization and familiarity with aseptic manufacturing.
Working understanding of lyophilization, formulation chemistry, mass balance, membrane filtration, and mixing technologies.
Working understanding of fill-and-finish machines and process equipment, including mixers, pumps, skids, filtration, CIP, and control systems.
Working understanding of single-use technologies.
Knowledge of manufacturing biopharmaceutical drug products, including biologics and small-molecule API, medical devices, and nanosuspension technologies.

Responsibilities

Provide technical leadership and guidance for defining scope, planning, scheduling resources, and overseeing MTS project support activities according to business proposals and site and client requirements.
Oversee staff in developing client-specific understanding of manufacturing processes; perform risk assessments and process modeling; author or review batch records, MCPs, and change controls; and conduct process monitoring through manufacturing data analysis and presentation.
Manage technical investigations to ensure robust root-cause analysis and impact assessments, and mentor the team in supporting ownership and resolution of other quality systems.
Manage MTS Engineers providing on-floor and on-call support for manufacturing operations.
Lead or conduct complex process deviation and out-of-specification investigations, determine root cause, assess potential impact to product and process, and lead corrective-action implementation.
Provide technical expertise for Safety, Compliance, and Quality Assurance activities during GMP batch execution to help achieve MTS team and site metrics.
Coach, mentor, and develop MTS team members in their responsibilities and personal development.
Provide technical leadership and subject-matter expertise for drug product and device-related deviations, change control, process optimization, and technical troubleshooting.
Track deliverables, drive projects to completion within established timelines, allocate and schedule MTS resources, and communicate project status cross-functionally.
Perform other duties as assigned.