Supervisor, Drug Product Manufacturing Formulations

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.

SUMMARY:

The Supervisor, Drug Product Manufacturing - Formulations manages the group responsible for all complex formulation manufacturing. This position is responsible for implementation of all production and manufacturing procedures to optimize formulation processes and regulatory requirements. The Supervisor, Drug Product Manufacturing - Formulations coordinates with other departments to plan, schedule, and execute all aspects of production operations related to complex formulations in a validated cGMP environment.

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• Overseeing daily operations, including formulation activities and troubleshooting any issues that may arise)
• Batch record review and generation, along with mixing studies
• Strategic planning with the Drug Product (DP) manufacturing team including defining the schedule coordinating preparation activates and troubleshooting any issues that may arise)
• Participating in client calls, kick off meetings, tours, and resolving operational issues
• Oversee internal investigations including deviations, corrective actions, preventative actions and product quality reviews
• Facility planning for site shutdowns, maintenance and APV planning
• Provide audit responses related to Client, QP, Regulatory Inspections, SOPs and Batch Record revisions
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in a life science or equivalent preferred.
• Minimum of 5 years’ relevant technical experience and minimum of 1 year of leadership experience.
• Understanding of cGMP's, and regulatory requirements.
• Solid command of chemistry.
• Understanding of complex formulation equipment, technical aspects of the processes and formulations.
• Experience using ERP systems (preferably QAD) and EQM systems (preferably ACE).
• Experience with LIMS, and RAM.

LEADERSHIP RESPONSIBILITIES:

• Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing- Formulations.
• Identifies, recruits, and retains top-notch talent.
• Champions PCI Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
• Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
• Provides oversight and direction to the employees in accordance with PCI Pharma’s policies and procedures.

The base salary hiring range for this position is $93,360 - $107,280 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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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.