What are the responsibilities and job description for the Manager, Pharmaceutical Manufacturing position at PCI Pharma Services?
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.
At PCI, you'll be part of a team that doesn’t just manufacture life-changing products—we do it with integrity, precision, and care. This is your opportunity to shape production strategy, lead a talented team, and collaborate cross-functionally to bring high-quality therapies and devices to the world.
What You’ll Do
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.
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.
At PCI, you'll be part of a team that doesn’t just manufacture life-changing products—we do it with integrity, precision, and care. This is your opportunity to shape production strategy, lead a talented team, and collaborate cross-functionally to bring high-quality therapies and devices to the world.
What You’ll Do
- Lead day-to-day operations across cleanrooms, component prep, formulation, aseptic filling, lyophilization, and packaging
- Supervise, coach, and schedule manufacturing staff to meet production goals and compliance standards
- Ensure strict adherence to cGMP, FDA, and global regulatory requirements (e.g., EU Annex 1)
- Own and support production documentation: batch records, deviations, CAPAs, investigations, SOPs
- Drive safety culture and ensure compliance with all safety procedures
- Partner with cross-functional teams—Validation, QA, Facilities, Project Management—to meet project milestones
- Support new product introductions, media fills, aseptic qualifications, and process validation
- Maintain inventory and supplies, assist with budgeting, and continuously seek process improvements and cost efficiencies
- Bachelor’s degree in a science-related field (or equivalent experience)
- Minimum 5 years in pharmaceutical or medical device manufacturing, with proven leadership in aseptic environments
- In-depth understanding of cGMP, ISO 5/6 operations, contamination control, and aseptic techniques
- Strong working knowledge of lyophilization, sterilization, cleanroom operations, and equipment troubleshooting
- Excellent organizational, communication, and leadership skills
- A proactive mindset with the ability to work independently and inspire teams
- Experience in writing and approving SOPs, deviation reports, change controls, and validation support documents
- Formal aseptic technique or contamination control training
- Experience supporting regulatory audits and media fill activities
- Familiarity with cleanroom gowning, disinfection protocols, and component sterilization
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.
