Job Description

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 Group Lead -2nd Shift performs various manufacturing tasks in accordance with established SOPs and cGMP regulations. The Drug Product Group Lead oversees non-exempt Drug Product Manufacturing staff and is responsible for establishing performance standards, coaching and developing employees, assigning responsibilities, evaluating performance, and providing appropriate recognition. In addition, the Group Lead reviews GMP documents and participates in process investigations and deviations while ensuring GMP compliance and inspection readiness. The Group Lead also assists 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: 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.

• Perform various manufacturing tasks in accordance with established 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 from manufacturing management.

• Direct manufacturing associates to help 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.

• 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:

• Champions PCI Pharma Service’s culture and empowers employees to take responsibility for their jobs and goals.

• Engages employees by creating a climate in which they want to do their best.

• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.

• Maintains employee work schedules.

• Provides oversight and direction to the employees in accordance with PCI Pharma Service’s 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. 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: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• High School Diploma required; bachelors 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 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.
  
  *The hiring rate for this position is $36.54 -$41.10 per hour 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.
  
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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.