Supervisor, Drug Product Manufacturing Formulations

PCI Pharma Services•San Diego, CA

1d•Onsite

About The Position

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. PCI Pharma Services is dedicated to delivering life-changing therapies and building teams across its global network to pioneer and shape the future. The company focuses on quality and operational excellence, providing an industry-leading customer experience, and fostering an authentic culture of purposeful work where talented individuals can grow their careers through intentional learning and real-life experience. PCI is committed to cultivating an inclusive workplace by holding itself accountable to the highest standards of understanding, fairness, respect, and equal opportunity.

Requirements

Minimum of 5 years’ relevant technical experience
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
Experience using EQM systems
Experience with LIMS
Experience with RAM

Nice To Haves

Bachelor's degree in a life science or equivalent
Experience using ERP systems (QAD)
Experience using EQM systems (ACE)

Responsibilities

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
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