Manager Process Specialists MTS

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Summary of Objective:

The Manager Process Specialists of Manufacturing Technologies and Sciences (MTS), reports to the Director -MTS, and is responsible for providing leadership, technical management, and professional development for the MTS Process Specialist team as well as collaborating between MTS Process Engineering, MTS management, Project Management, Process Development, Purchasing, Validation, Quality, Safety & Manufacturing teams. A major responsibility for the Manager is to provide technical support and strategic direction to internal stakeholders and external clients, providing guidance to technical writing and decision making in the execution of the specific client project deliverables, all performed in a timely manner. The Managers' actions support overseeing of technical services into PCI manufacturing, plant floor operations (formulation/fill/finish/lyophilization), supporting continuous improvement and development of support manufacturing documentation.

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.

• Lead and manage the Process Specialist team within MTS, including hiring, training, and development of team members to ensure a high-performing and collaborative workforce.

• Develop and implement MTS documentation standards, templates, and processes to ensure consistency, accuracy, and clarity in technical documentation produced by the team.

• Plan and prioritize technical writing projects, including batch records, Quality Systems (Change Controls, CAPA's, etc), standard operating procedures (SOPs), and other documentation, in collaboration with cross-functional teams.

• Collaborate with subject matter experts (SMEs) across departments, including MTS, Process Development, Manufacturing, Quality, and Regulatory Affairs, to gather information and ensure accuracy and completeness of documentation.

• Manage the revision and approval process for technical documentation, tracking changes and ensuring compliance with version control procedures.

• Support the resolution of manufacturing issues and provide technical support of critical process-related deviations in terms of leading root cause investigations and implementation of robust corrective or preventative actions.

• Support the technology transfer of processes from internal and external development groups, efficiently assessing risks to project objectives, reducing risk through collaborative studies, and supporting manufacturing cGMP lots.

• 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.

• Provide technical perspective during internal and external audits, regulatory inspections and due diligence as appropriate.

• Facilitate tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.

• Interface directly with all clients to ensure the highest level of customer satisfaction is achieved.

• Demonstrate and promote continuous improvement in efficiency, quality, and safety through technical development, job knowledge, education and training. Implementation of associated changes utilizing various quality systems as necessary.

• Remain current with biopharmaceutical industry best practices, technologies and developments in their respective specialization or practice by actively engaging in and participating in professional organizations.

• Build and lead a team of process specialists who will work closely together and within a highly matrixed, cross-functional team to successfully deliver business objectives.

• Key technical leadership for clinical/commercial stage programs including technology transfer, validation, process design, and manufacturing support.

• Develop and implement strategies for continuous improvement across manufacturing processes that reduce cost, save time, improve process attributes, and optimize quality.

• Interpret manufacturing process data, identify trends, troubleshoot problems, and drive data-driven decision-making with effective and concise communications.

• Coordinate the preparation, review, and approval of technical documentation, ensuring adherence to regulatory requirements (e.g., cGMP, FDA guidelines) and project timelines.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to adapt quickly to shifting departmental and organization priorities.

• Excellent interpersonal skills with ability to be persistent and persuasive.

• Must be able to develop GMP complaint solutions while challenging existing systems and processes to meet project needs.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• A flexible style which fosters the rigidity of GMP operations against the competing demands of clients and projects

• Motivate and engage staff by communicating vision and objectives of department related to organization goals with alignment to the corporate business objectives

• Ability to separate personal from professional especially when dealing with external clients, maintain a high level of professionalism in all communications

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.

• BS/MS in chemical, mechanical, pharmaceutical engineering or relevant work experience. Comparable blends of education and experience is acceptable.

• 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 large projects and initiatives to completion.

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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.