Drug Product Development & Manufacturing Manager

$140,000 - $164,000/Yr

Cerus - Concord, CA

Full-time - Senior

Concord, CA

Professional, Scientific, and Technical Services

About the position

The Drug Product Development & Manufacturing Manager at Cerus Corporation will be a key member of the Chemistry, Manufacturing, and Controls (CMC) team, responsible for overseeing drug product process development and commercialization activities. This role involves strategic planning, coordination, and execution of projects aimed at securing the blood and plasma supply for patients globally. The manager will work in a cross-functional environment, ensuring that manufacturing timelines are met while collaborating with internal teams and contract manufacturing organizations.

Responsibilities

• Support projects intended to secure 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 and ensure adherence to defined budgets and timelines.
• Communicate complex technical data and principles through oral 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.
• Experience in cGMP manufacture of parenteral drug products using aseptic techniques and/or terminal sterilization.
• 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

• Employee stock purchase plan
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• RSU
• Tuition reimbursement
• Parental leave
• Employee assistance program
• Vision insurance
• 401(k) matching