Location: Lusk

The Drug Product Manufacturing Supervisor is responsible for the implementation of all production and manufacturing procedures to optimize processes and ensure regulatory compliance. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment

Schedule:
Generally 2:00PM - 10:30PM
*Eligible for 10% differential when working 2nd shift hours

Essential Duties and Responsibilities:

• Oversee daily operations, including formulation, filtration, filling, and troubleshooting issues with complex fill-finish equipment systems.
• Author and review batch records and ensure compliance with applicable GMP processes.
• Execute strategic planning with drug product manufacturing and other internal teams, including defining schedules, coordinating preparation activities, and troubleshooting issues that arise.
• Participate in client calls, interactions, and meetings including kick-off meetings, facility tours, and resolving operational or quality issues.
• Participate in internal investigations, including deviations, corrective actions, preventative actions, and product quality reviews.
• Support facility planning for shutdowns, maintenance, HEPA certifications, qualifications, and media fill planning.
• Provide audit responses related to client, QP, and regulatory inspections, as well as SOP and Batch record revisions.
• Collaborate with the Quality team regarding EM investigations, OOS investigations, and deviation investigations
• 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 Service's cultural values and aligns daily actions with department goals and company culture.
• Foster a safe and environmentally sustainable workplace by ensuring compliance with all PCI EHS policies and procedures

Leadership Responsibilities:

• Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing.
• Identifies, recruits, and retains top-notch talent.
• Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
• Coaches, mentors, engages and develops 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 Services policies and procedures.

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 of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• occasionally required to sit, and to reach to use computers and other office equipment
• constantly stand for extended periods of time, up to four (4) hours/time.
• frequently required to lift up to 50 pounds
• constantly required to view objects at close and distant ranges with hand and eye coordination
• frequently required to communicate with others
• constantly performs duties while donning aseptic gowning.

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Qualifications:

• Bachelor's degree in life sciences discipline or equivalent required
• Minimum of five (5) years of experience in relevant technical experience
• Minimum of 1 year leadership experience.
• Understanding of cGMP's.
• Understanding of regulatory requirements.
• Solid command of chemistry.
• Understanding of fillers and processes regarding filling.
• Understanding of QAD, ACE, LIMS, and RAM.

*The hiring rate for this position is $85,120 -$95,760 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), a flexible spending account, and a 401(k) plan.

Eligible for 10% differential when working 2nd shift hours.
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