Drug Product Manufacturing Group Lead - 2nd Shift

PCI Pharma Services•San Diego, CA

11h•Onsite

About The Position

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

Requirements

High School Diploma required
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.

Nice To Haves

bachelors in a science or engineering discipline preferred.

Responsibilities

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
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.