Supervisor, Drug Product Manufacturing - 2nd Shift

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.

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

This position would be for 2nd Shift*: 3:00PM - 11:30PM

*Eligible for 2nd shift 10% pay differential

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• Oversee daily operations (formulation, filtration, filling and troubleshooting of any issues with complex fill finish equipment systems.

• Batch Record authoring and reviewing applicable GMP processes.

• Strategic planning with drug product manufacturing and other internal teams including defining schedule, coordinating preparation, and troubleshooting any issues that may arise.

• Participate in client calls, interactions and meetings including kick-off meetings, tours, and resolving operational or quality issues.

• Participate in internal investigations including deviations, corrective actions, preventative actions, and product quality reviews.

• Facility planning for shutdowns, maintenance, HEPA certifications, qualifications and media fill planning.

• Provide audit responses related to Client, QP, and Regulatory Inspections, SOP and Batch record revisions.

• Interact 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 Services cultural values and aligns daily actions with department goals and company culture

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, engagesand 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

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• 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.

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

While performing the duties the employee is:

• constantly 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

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.

Work Environment:

Employee will work with moderate noise levels. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required.

This job description may not list all activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or be assigned at any time with or without notice.

*The hiring rate for this position is $85,120.00 -$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 2nd Shift 10% pay differential

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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.