Senior Manager, Operations Support

LSNE Contract Manufacturing

Bedford (NH)

On-site

USD 120,000 - 160,000

Full time

29 hours ago
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Job summary

PCI Pharma Services in Bedford, NH seeks a senior leader to guide the Operations Support group across multiple sites. You will build and mentor a process-specialist team, develop schedules aligned with customer demands, and oversee technical writing, investigations, CAPAs and SOPs to ensure compliance and efficiency.

You will drive continuous improvement, manage key performance metrics, and act as SME during audits while interfacing with clients and vendors to deliver exceptional customer

Qualifications

  • 8+ years of technical experience in Life Sciences or Medical Device with GMP background.
  • BS/MS in chemical, mechanical, pharmaceutical engineering or relevant.
  • Experience leading large projects and initiatives to completion.
  • Prior people management experience required.
  • Strong leadership, initiative and problem-solving abilities.

Responsibilities

  • Provide technical leadership and strategic oversight for the Operations Support group across PCI Manufacturing sites at the Bedford campus.
  • Build and lead a team of process specialists within a matrixed organization.
  • Develop and manage Manufacturing and VI finite schedules to align with customer demands.
  • Plan and prioritize technical writing projects (investigations, CAPAs, SOPs, etc.).
  • Lead investigations to drive deviation resolution with root cause analysis.
  • Establish and monitor safety, quality, on-time/right-first-time delivery, inventory, and productivity metrics.
  • Develop and implement continuous improvement strategies to reduce cost and improve quality.
  • Interpret manufacturing data, identify trends, troubleshoot, and drive data-driven decisions.
  • Serve as SME during customer and regulatory audits and interface with clients and vendors.

Skills

Technical leadership
GMP experience
People management
Project management
Communication

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
  • 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
  • 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.

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