Manager, Drug Product Manufacturing - 2nd Shift

PCI San Diego, Inc.; San Diego (CA); On-site; USD 107,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a Manager, Drug Product Manufacturing - 2nd Shift to lead day-to-day DP manufacturing operations, including fill & finish, in a validated cGMP environment. The role collaborates across departments to plan, schedule, and execute production with a focus on quality and regulatory adherence.

Qualified candidates have a bachelor’s in a scientific field, 7+ years in manufacturing, and 3+ years of supervisory experience, plus strong knowledge of cGMPs and related systems.

Qualifications

• Bachelor’s degree in scientific discipline or equivalent experience.
• 7+ years of related technical experience.
• 3+ years of leadership/supervisory experience.
• Understanding of cGMPs and regulatory requirements.
• Solid command of chemistry including fillers and filling processes.
• Knowledge of QAD, MasterControl, LIMS, and RAM.

Responsibilities

• Oversees daily operations including formulation, filtration, filling and troubleshooting any issues.
• Batch record review and generation (Client calls and Project Management interactions).
• Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting.
• Client calls, interactions and meetings (kick off meeting, tours, and operational issues).
• Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).
• Facility planning (Shutdowns, maintenance, HEPA certifications, and media fill planning).
• Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions).
• Quality interactions (EM investigations, OOS investigations, Deviation Investigations).
• Full-time attendance and professional behavior aligned with PCI policies.
• Builds sound working relationships with internal departments and external clients.

Skills

Leadership

cGMP knowledge

Regulatory knowledge

Chemistry basics

Cross-functional

Problem solving

Education

Bachelor’s degree in science

Tools

QAD

MasterControl

LIMS

RAM

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.

Location: Lusk

Position

We are currently looking for Manager, Drug Product Manufacturing - 2nd Shift. This position is responsible for managing the day-to-day activities of fill & finish manufacturing. This position is responsible for implementation of all production and manufacturing equipment and procedures to optimize processes and regulatory requirements. The Manager coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment. 2nd Shift starts generally at 2:00PM Eligible for 10% pay differential when working 2nd shift hours.

Essential Duties and Responsibilities

• Oversees daily operations including formulation, filtration, filling and troubleshooting any issues.
• Batch record review and generation (Client calls and Project Management interactions)
• Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting.
• Client calls, interactions and meetings (kick off meeting, tours, and operational issues).
• Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).
• Facility planning (Shutdowns, maintenance, HEPA certifications, and media fill planning).
• Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions)
• Quality interactions (EM investigations, OOS investigations, Deviation Investigations)
• 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.
• Proactively assumes responsibility that assignments are executed properly, attaining desired outcomes on schedule and meets quality standards.
• Builds and establishes sound working relationships with internal departments and external clients in support of company goals.
• Supports, encourages, and collaborates with others, especially in difficult and high-pressure situations.
• Embodies PCI Pharma Services 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

• Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing.
• Identifies, recruits, and retains top-notch talent.
• Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
• Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains transparent communication.
• Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
• Provides oversight and direction to the employees in accordance with PCI Pharma Services 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: constantly 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.
• 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

• Bachelor’s degree in scientific discipline or equivalent experience required.
• Minimum of seven (7) years of related technical experience.
• Minimum of three (3) year of leadership/supervisory experience.
• Understanding of cGMP's.
• Understanding of regulatory requirements.
• Solid command of chemistry including understanding of fillers and processes regarding filling.
• Understanding of QAD, Master Control, LIMS, and RAM.

Compensation and Benefits

*The hiring rate for this position is $106,800 -$120,150 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.

Eligible for 10% pay differential when working 2nd shift hours.

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

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.

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.

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.