Manager, Drug Product Manufacturing

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

Job summary

PCI Pharma Services in San Diego, CA is seeking a Manufacturing Manager to oversee day-to-day fill & finish operations in a validated cGMP environment. You will coordinate with DP manufacturing to plan, schedule, and execute production while ensuring quality and compliance.

Qualifications include a Bachelor’s degree in a scientific discipline, 7+ years of related experience with 3+ years of leadership, and strong knowledge of cGMPs and QAD/LIMS systems.

Qualifications

• Bachelor’s degree in scientific discipline or equivalent experience.
• 7+ years of related technical experience. Minimum of 3 years 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.

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.

Skills

Leadership

cGMP knowledge

Regulatory knowledge

Chemistry knowledge

Quality systems

Education

Bachelor’s degree in scientific discipline

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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• 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, engageand 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

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required

• 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. 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.

Join us and be part of building the bridge between life changing therapies and patients.

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.

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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