Lead, Drug Product Manufacturing Operations

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

Benefits offered by this job

Paid time off

Health insurance including dental and

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services is seeking a senior manufacturing leader to manage day-to-day fill & finish operations in a validated cGMP environment. The role drives schedules, coordinates with DP manufacturing, and ensures quality through investigations and audits.

You will lead client communications, batch reviews, and cross-functional collaborations while maintaining professional standards and schedule adherence.

Qualifications

• Bachelor's degree in scientific discipline or equivalent experience.
• Minimum of seven years of related technical experience and three years of leadership.
• Understanding of cGMP's and regulatory requirements.
• Solid command of chemistry including fillers and processes.

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 and coordinating preparation.
• Client calls, interactions and meetings, and handling operational issues.
• Internal investigations (Deviations, CAPA, Product Quality reviews).
• Audit responses (Client, QP, regulatory inspections) and SOP revisions.

Skills

Leadership

Regulatory knowledge

Quality systems

Education

Bachelor's degree in scientific discipline

Tools

QAD

Master Control

LIMS

RAM

Job description

PCI Pharma Services is seeking a senior manufacturing leader to manage day-to-day fill & finish operations in a validated cGMP environment. The role drives schedules, coordinates with DP manufacturing, and ensures quality through investigations and audits.

You will lead client communications, batch reviews, and cross-functional collaborations while maintaining professional standards and schedule adherence.