Drug Product Manufacturing Group Lead - 2nd Shift

Drug Product Manufacturing Group Lead – 2nd Shift Perform various manufacturing tasks in accordance with established SOPs and cGMP regulations. Oversee non‑exempt Drug Product Manufacturing staff, establish performance standards, coach and develop employees, assign responsibilities, evaluate performance, and provide recognition. Review GMP documents and participate in process investigations and deviations while ensuring GMP compliance and inspection readiness. Assist middle and upper management with interviewing and retaining talent. 2nd Shift: generally starts at 3:00pm. Eligible for 10% shift differential when working 2nd shift hours. Essential Duties and Responsibilities Perform manufacturing tasks in accordance with SOPs and cGMP regulations. Write deviations, OOS reports, and other investigations pertaining to the group. Work with management to implement process improvements, training, new projects, and facility repairs. Perform troubleshooting of mechanical issues that arise with manufacturing equipment. Schedule manufacturing tasks in accordance with cGMP guidelines under minimal supervision. Direct manufacturing associates to streamline processes and ensure operational oversight. Serve as a subject matter expert for specific pieces of equipment. Communicate issues or deviations in a timely manner to the client. May troubleshoot semi‑complex manufacturing processes under cGMP guidelines with supervision from the manufacturing supervisor. Develop expertise in specific manufacturing areas that add value to the company. Lead the research and implementation of new methods and technologies to enhance operations. Routinely implement production and manufacturing procedures. Accurately document data and write/review batch records in compliance with cGMP guidelines. Perform routine maintenance of production equipment and manufacturing suites; may research and procure equipment for multiple manufacturing processes. Initiate and author revisions to current GMP/SOP guidelines; reliably execute and author well‑defined SOPs and manufacturing batch records. Maintain regular and reliable attendance on a full‑time basis or in accordance with posted schedule. Exhibit 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 Champion PCI Pharma Service’s culture and empower employees to take responsibility for their jobs and goals. Engage employees by creating a climate in which they want to do their best. Set performance standards and encourage employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintain employee work schedules. Provide oversight and direction to the employees in accordance with PCI Pharma Service’s policies and procedures. Special Demands Physical demands include occasional sitting, reaching to use computers and other office equipment, standing for extended periods (up to four hours per time), frequently lifting up to 50 pounds, constantly viewing objects at close and distant ranges with hand and eye coordination, frequently communicating with others, and performing duties while donning aseptic gowning. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. Qualifications High School Diploma required; bachelor’s degree in a science or engineering discipline preferred. Minimum of five (5) years of experience in manufacturing or laboratory environment without a degree, or a minimum of four (4) years of experience in manufacturing or laboratory environment with a degree. Minimum of one (1) year of functional or day‑to‑day leadership experience. Detail oriented with strong written and verbal communication skills. Ability to work independently within prescribed guidelines or as a team member. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Ability to work autonomously and collaborate effectively with team members. Self‑motivated. Compensation & Benefits $36.54 – $41.10 per hour plus eligibility for an annual performance bonus. PCI offers 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. Equal Employment Opportunity 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. #J-18808-Ljbffr PCI TRGR Penn Pharmaceutical Services Ltd