Drug Product Development & Manufacturing Manager

$140,000 - $164,000/Yr

Cerus - Concord, CA

Full-time - Mid Level

Concord, CA

Professional, Scientific, and Technical Services

About the position

The Drug Product Development & Manufacturing Manager at Cerus will be a key member of the Chemistry, Manufacturing, and Controls (CMC) team, responsible for supporting projects that ensure the safety and accessibility of blood and plasma supplies for patients globally. This role involves strategic planning, coordination, and execution of drug product process development and commercialization activities in a cross-functional environment, working closely with internal teams and contract manufacturing organizations.

Responsibilities

• Support projects aimed at securing the blood and plasma supply to patients globally.
• Coordinate and execute drug product process development and commercialization activities.
• Work in a cross-functional environment to ensure manufacturing timelines are met.
• Manage multiple projects simultaneously while adhering to defined budgets and timelines.
• Communicate complex technical data and principles through presentations and written summaries.
• Write technical reports and CMC sections for regulatory submissions.

Requirements

• M.S. or Ph.D. in a scientific discipline (chemical engineering, pharmaceutical science, or closely related discipline).
• Minimum of 10 years' experience in the Pharmaceutical, Biotech, or Medical Device industries.
• Familiarity with lyophilization technology for pharmaceutical applications.
• Knowledge of polymeric materials for medical devices and familiarity with extractables and leachables studies.
• Thorough understanding of drug product process development and characterization principles.
• Experience in cGMP manufacture of parenteral drug products using aseptic techniques and/or terminal sterilization.
• Experience in selecting and managing CMOs and executing necessary agreements.
• Up-to-date knowledge of FDA, EMA, USP, Ph.Eur., ISO, and WHO requirements related to medical device, biologics, and pharmaceutical manufacturing processes.
• Excellent verbal and written communication skills.

Nice-to-haves

• Experience with sterilization techniques, especially terminal sterilization.
• Experience with AI, statistical design of experiments (DoE), and multivariate data analysis.

Benefits

• Medical, dental, and vision insurance.
• Domestic partner benefits.
• Paid maternity and paternity leaves.
• Healthcare and dependent care flexible spending accounts.
• Life and accidental death insurance.
• Long-term and short-term disability insurance.
• Matching 401(k) plan.
• Employee Stock Purchase Plan (ESPP).
• Restricted Stock Units (RSUs).
• Employee Assistance Program (EAP).
• Legal and financial services.
• Health club membership discounts.
• Tuition reimbursement.