SUPERVISOR, MANUFACTURING

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 of Objective:

The Manufacturing Supervisor leads a manufacturing team in a variety of complex tasks in accordance with the FDA and other regulatory agencies while following all safety guidelines of PCI. They will be responsible for supervising an aseptic and medical device manufacturing team (ex. equipment preparation, filling and Lyophilization activities). Ensure execution of production plans across multiple shifts and manage staff performance against department's operational goals.

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

• Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program.
• Be highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams while managing for high performance and developing others
• Coordinate and supervise Manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work
• Partner with Planning to ensure effective prioritization and schedule adherence and to meet all required capacity demands
• Guide and train employees to ensure FDA and other regulatory agency requirements have been properly implemented and are continually met.
• Plan and execute manufacturing instructions in order to perform equipment preparation, and fill activities for aseptic and non-aseptic products in accordance with Good Manufacturing Practices (GMP)
• Collaborate with the other supervisors and enabling groups to optimize processes
• Recruit and supervise staff to execute department functions; ensure effective utilization of resources through consistent performance management
• Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards
• Proactively identifies, assesses, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
• Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics
• Collaborate with training to design department training plan and training plan execution. Ensure Training materials are accurate and sufficiently detailed
• Ensure Timely completion of investigations, deviations and CAPAs. Utilize quality metrics to measure, analyze, and improve team performance. Ensure Real time batch review and "Right First Time"
• Ensure Inspection readiness of assigned manufacturing areas. Participates in inspections conducted by external clients and regulators
• Identifies continuous improvement opportunities to improve processes and practices

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

QUALITIES -

• Attention to detail
• Team oriented
• Results driven
• Collaboration
• Comfortable with communication skills to all levels of the organization

PHYSICAL REQUIREMENTS & MENTAL DEMANDS -

• undefined
• Lifting/Pushing/Pulling up to 40lbs - <25%
• Walking - <25%
• Standing - <25%
• Sitting - <25%
• Bending - <25%
• Stooping - <25%
• Kneeling - <25%
• Able to travel between PCI facilities
• Successfully prioritize and manage multiple tasks/projects

COMMUNICATIONS & CONTACTS -

• The supervisor will be responsible for communicating the status of all projects to their Manufacturing Manager
• Interacts with cross functional support teams such as Operations, Materials Management, Engineering, MTS, R&D, Validation, QA, etc.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -

• Responsible for directing activities of staff members
• Prepare employee performance evaluations
• Recommend merit increases based on performance
• Must be able to observe and identify potential employees' issues and recommend/carryout disciplinary action as necessary
• There are multiple direct reports including various levels of Manufacturing Technicians
• Collaborate with other Manufacturing Supervisors as necessary to carryout responsibilities

TRAVEL - <10%

• undefined

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

Ø Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.

Ø Work is also performed in ISO-rated cleanroom environments, requiring special factors such as sterile gowning.

Ø The noise level in the work environment is typically, moderate.

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.

• Minimum High School Diploma
• 5-7 years of experience in a GMPs environment required
• 3-5 years of experience leading direct reports or teams is preferred
• Experience with GMPs, FDA and other regulated agency environments is required
• Experienced in making real time decisions on safety, process, scheduling and personnel-related issues.
• Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs
• Proven leadership, persuasiveness, initiative, and problem solving skills

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.