Senior Manager, Operations Support

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 120,000 - 180,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks an experienced Operations leader to provide strategic oversight for the Operations Support group across multiple manufacturing sites. You will build and guide a matrixed team of process specialists, align schedules to customer demand, and drive continuous improvement across manufacturing processes.

The role requires deep GMP experience, strong leadership, and a track record of delivering results through coaching, mentoring, and disciplined performance

Qualifications

• 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.

Responsibilities

• 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 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.

Skills

Technical leadership

Cross-functional

People management

Data analysis

Education

BS/MS in chemical, mechanical, pharmaceutical engineering

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Essential Duties and Responsibilities

• 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

• 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.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program.

We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.