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 strategic oversight for the Operations Support group across multiple PCI Manufacturing sites at the Bedford campus.
- 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.
- Develop and manage Manufacturing and Visual Inspection (VI) finite schedules to align with customer demands and PCI objectives.
- Plan and prioritize technical writing projects, including: investigations, Quality Systems (Change Controls, CAPAs, etc), Standard Operating Procedures (SOPs), and other documentation, in collaboration with cross-functional teams.
- Lead a team that oversees investigations to drive resolution of deviations, ensuring effective root cause analysis and corrective actions.
- Establish, analyze, and maintain key performance metrics, including: safety, quality, on-time/right-first-time delivery, inventory, and productivity.
- 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.
- Serve as a department Subject Matter Expert (SME) during customer and regulatory audits.
- Interface directly with all clients to ensure the highest level of customer satisfaction is achieved.
- Act as a highly visible, hands-on leader, responsible for coaching, mentoring, and developing high-performing teams while fostering a culture of accountability and excellence.
- Oversee the professional development of the Operations Support team, conducting individual performance reviews, setting goals, and driving employee growth.
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.
- Ability to stand, sit or remain in the same position for extended periods of time.
- May be required to travel between sites at the campus.
- Follow written instructions.
- Able to train others.
- Able to work in a highly complex environment with competing demands and priorities.
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.
- Primarily interacts with staff in the following departments at all levels: Operations, Quality, Project Management, Engineering, Supply Chain, and MSAT.
- Will frequently interact with clients and client representatives.
- Will frequently interact with external vendors.
- Manage 4-5 Direct reports, supporting a team of 10-15 Indirect Reports.
TRAVEL - Travel to various PCI locations up to 15% annually.
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 with Life Sciences (Biopharmaceutical / Biotechnology) and/or Medical Device with GMP industry experience.
- 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, Technical Project Management, and or Quality. 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.
- Positive attitude with strong interpersonal skills.
- Proven leadership, persuasiveness, initiative, and problem-solving abilities.
- Strong communication skills, both verbal and written.
- Able to inspire and motivate.
- Self-motivated with a drive for excellence.
- Resilient through operational and organizational change.
- Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs.
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