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Manufacturing Science and Technology (MTS) Manager
The Manufacturing Science and Technology (MTS) department is the keeper of the body of manufacturing process knowledge. The department supports, and in some cases drives, the development and technical transfer of new technologies and manufacturing processes which includes developing batch records, ensuring that manufacturing operations stay aligned with client specified processes. The department also supports technical investigations and improvement projects to mitigate manufacturing non-conformances and enhance productivity.
The Manager of Manufacturing Science and Technology (MTS), reports to the General Manager, and is responsible for providing leadership, technical management and professional development for the MTS Engineering and Specialist Team as well as collaborating between Project Management, Process Development, Validation, Quality Control, Quality, Safety & Manufacturing teams. A major responsibility for the Manager is to provide technical support to internal (Project Management, Manufacturing, Quality) stakeholders and external clients, providing guidance with technical writing and decision making in the execution of the specific client project deliverables, all performed in a timely manner.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Provide technical leadership and guidance to both internal and external requirements for defining scope, planning, scheduling resources and overseeing the MTS project support activities according to business proposals and site/client’s requirements.
- Oversee staff in client specific understanding of their manufacturing processes. Perform risk assessments, generate process models, author/review Batch Records/MCPs, author/review change controls, perform process monitoring (manufacturing data analysis and presentation).
- Manage technical investigations to assure robust, technically sound root cause analysis and impact assessments. Mentor and manage team to also support ownership and resolution of other quality systems.
- Manage MTS Engineers for on-floor and on-call support for manufacturing operations (process support team).
- Individually, as the core technical SME as appropriate, develop and manage either cross-functional investigational teams or perform individual investigations, of complex process deviations and out-of-specification results associated with processes to determine root cause, assess potential impact to product and process and lead implementation of corrective actions.
- Provide technical knowledge/expertise to support the Safety, Compliance and Quality Assurance activities required during GMP batch execution to ensure MTS team and site metrics are achieved.
- Provide direct coaching, mentoring and development to each member of the MTS both in execution of their responsibilities and in their own personal development.
- Provide technical leadership and subject matter expertise relating to drug product/device related deviations, change control, process optimization, and technical troubleshooting.
- Track deliverables, driving completion of projects to established business timelines, allocating and scheduling MTS resources and collaborating/communicating cross-functionally on project status.
- Other Duties as assigned.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum of 8 years of technical experience within Life Sciences (Biopharmaceutical/Biotechnology), Medical Device or Aseptic Manufacturing Organization with GMP industry experience. Prior lyophilization experience a plus.
- Strong hands on experience in either Process Engineering/Sciences, Manufacturing Operations, or Technical Project Management. Experience preferably in a biopharmaceutical or medical device manufacturing organization with familiarity with aseptic manufacturing a plus.
- Prior people managing experience, supervisory experience at a minimum.
- Experience leading and driving projects to completion.
- Experience managing projects relating to GMP manufacturing: including investigations, change control, process optimization, technical transfer, process troubleshooting, batch record implementation, and improving GMP manufacturing operations.
- Experience and working understanding with the following GMP operations are preferred:
- Lyophilization, formulation chemistry, mass balance, membrane filtration, mixing technologies.
- Fill & finish machines, process equipment (mixers, pumps, skids, filtration, CIP, control systems),
- Single use technologies.
- Ability to manage team of MTS engineers and specialists with coaching, career development, building a high performing, engaged and effective team through motivation and inspiration.
- Full understanding of cGMP’s, regulatory compliance, and safety regulations.
- Knowledge of the manufacturing of biopharmaceutical (biologics, small molecule API) drug products, medical devices, nanosuspension technologies is desired. An understanding of scientific principles related to GMP processing as well as experimental design is required.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
