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: Responsible for ensuring the manufacturing department (ex. equipment preparation, formulation, filtration, aseptic, non-aseptic compounding, preparation, packaging and filling activities) executes the production plan across multiple shifts 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. Assists in coordinating of manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work Ensure efficient operation of process floor activities by developing processes, materials, GMP and safety controls Guide and train employees to ensure QSR and ISO requirements have been properly implemented and are continually met. Partner with Quality to ensure a cGMP operation Assist team in planning and execution of manufacturing instructions in order to perform equipment preparation, compounding, filtration, formulation and fill activities for aseptic and terminally non-aseptic products in accordance with Good Manufacturing Practices (GMP) standard operating procedure, applicable Quality System and Regulatory requirements Become a highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams Collaborate with the Operations, Material Management, Engineering, MTS, finance, and R&D teams to optimize processes, specifically applying Lean principles if applicable Drive efforts to address regulatory compliance issues related to production. Responsible for maintaining the highest level of regulatory compliance Work with Manufacturing Supervisors to provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards Partner with the Manufacturing Scheduler to ensure accuracy of and adherence to production schedules Ensure that appropriate levels of trained resources are available to meet production schedules 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 Ensure staff has appropriate knowledge of processes and procedures to perform responsibilities Ensure manufacturing instruction set and production records reflect practice, are aligned to cGMPs/ISO and corporate standards 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 and 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 regulators, as required Identifies continuous improvement opportunities to improve processes and practices Partner with cross-functional groups to evaluate and drive resolution of operational issues and proactively drive continuous improvement projects to completion Act as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs Assist in operations to provide training and guidance as necessary Act as SME and primary trainer to potential operations trainers Other duties as assigned 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. PROFESSIONAL SKILLS - Intermediate/advanced PC skills, MS Office and Microsoft project applications is required Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs Excellent communication skills both verbal and written QUALITIES – Assertive, self-directed, and a good team player with previous operations and experience in Six Sigma is a plus Results driven: Collaboratively set realistic, challenging, measurable goals and timetable Keep self and others focused on key performance indicators Adaptability: Maintain effectiveness in continually changing work environment Proven leadership, persuasiveness, initiative, project management, lean knowledge and problem-solving skills are necessary for success in this position Adjust quickly to work within new work structures, processes, requirements or cultures PHYSICAL REQUIREMENTS - Ability to lift 25 pounds Ability to stand, sit or remain in the same position for long periods of time May be required to travel between sites 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. COMMUNICATIONS & CONTACTS - Interacts with cross functional support teams such as Operations, Materials Management, Engineering, MTS, R&D, Validation, etc. MANAGERIAL & SUPERVISORY RESPONSIBILITIES – Not Applicable TRAVEL – 20% 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. EDUCATION – Bachelor’s Degree in a Science related field EXPERIENCE – 7-10 years of experience in a cGMPs/ISO environment. Strong understanding of cGMPs/ISO Experience with GMP, ISO and/or an FDA regulated environment is required Experienced in making tactical decisions on safety, process, and scheduling issues Experience working with cross-functional teams, including Quality, Manufacturing Technical Support Experienced in troubleshooting, investigation, root cause and risk analysis in a CGMP environment 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, Diversity, Equity, and Inclusion (DEI) 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. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.