MTS Manager

PCI Pharma Services•Madison, WI

About The Position

The Manufacturing Science and Technology (MTS) Manager leads the MTS Engineering and Specialist Team and is responsible for its technical management and professional development. Reporting to the General Manager, the role collaborates with Project Management, Process Development, Validation, Quality Control, Quality, Safety, and Manufacturing teams. The MTS department maintains manufacturing process knowledge and supports or leads development and technical transfer of technologies and processes. It develops batch records, helps ensure manufacturing operations remain aligned with client-specified processes, and supports technical investigations and improvement projects. The Manager provides technical support to internal stakeholders and external clients, including guidance on technical writing and project decisions, while ensuring timely delivery of client project commitments.

Requirements

At least 8 years of technical experience in Life Sciences (Biopharmaceutical/Biotechnology), Medical Device, or Aseptic Manufacturing, with GMP industry experience.
Strong 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 improvements to 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 cGMP, 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; familiarity with aseptic manufacturing is a plus.
Experience or working understanding of lyophilization, formulation chemistry, mass balance, membrane filtration, and mixing technologies.
Experience or working understanding of fill-and-finish machines, process equipment such as mixers, pumps, skids, filtration systems, CIP, and control systems, and single-use technologies.
Knowledge of manufacturing biopharmaceutical drug products, including biologics and small-molecule APIs, medical devices, and nanosuspension technologies.

Responsibilities

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