Manager, Drug Product Manufacturing

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 107,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage

401(k) plan

Job summary

PCI Pharma Services in San Diego, CA, is seeking a senior manager to oversee day-to-day Drug Product Manufacturing operations including fill/finish processes in a cGMP environment. You will coordinate with cross-functional teams to plan, schedule and execute production activities, ensuring regulatory compliance and quality standards.

The role requires a Bachelor's in a scientific field, 7+ years of technical experience, and 3+ years in a leadership position.

Qualifications

• Bachelor’s degree in scientific discipline or equivalent experience.
• 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.

Responsibilities

• Oversees daily operations including formulation, filtration, filling and troubleshooting.
• 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.

Skills

Leadership experience

cGMP knowledge

Regulatory knowledge

Quality systems

Fill/finish chemistry

QA & CAPA

Education

Bachelor’s degree in science

Tools

QAD

Master Control

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.

Summary

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.

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.

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 and 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.

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.

*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.

Salary and Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• Flexible spending account
• 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. 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.

If You Are a Resident of California or Applying for a Job in California

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair-chance

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.