Drug Product Development & Manufacturing Manager
Apply NowCompany: Cerus
Location: Concord, CA 94521
Description:
About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
This role requires the Manager to be onsite at least 3 days a week.
Summary and Scope:
The highly motivated Drug Product Development & Manufacturing Manager will be a member of our Chemistry, Manufacturing, and Controls (CMC) team. You'll have the opportunity to support projects intended to secure the blood and plasma supply to patients globally. You will work on medical systems at the exciting interface of medical devices, drugs, and biologics and apply their skills in a creative and fast-paced environment. The Drug Product Development & Manufacturing Manager will play an integral part in strategic planning, coordination, and execution of drug product process development and commercialization activities as part of a multi-disciplinary team incorporating internal Cerus functions and contract manufacturing organizations. The Manager will work in a cross functional environment to ensure manufacturing timelines are met.
Qualifications:
We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the selected city is $140,000-$164,000 annually. Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
This role requires the Manager to be onsite at least 3 days a week.
Summary and Scope:
The highly motivated Drug Product Development & Manufacturing Manager will be a member of our Chemistry, Manufacturing, and Controls (CMC) team. You'll have the opportunity to support projects intended to secure the blood and plasma supply to patients globally. You will work on medical systems at the exciting interface of medical devices, drugs, and biologics and apply their skills in a creative and fast-paced environment. The Drug Product Development & Manufacturing Manager will play an integral part in strategic planning, coordination, and execution of drug product process development and commercialization activities as part of a multi-disciplinary team incorporating internal Cerus functions and contract manufacturing organizations. The Manager will work in a cross functional environment to ensure manufacturing timelines are met.
Qualifications:
- M.S. or Ph.D. in a scientific discipline (chemical engineering, pharmaceutical science, or closely related discipline) and a minimum of 10 years' experience in the Pharmaceutical, Biotech or Medical Device industries
- Familiarity with lyophilization technology for pharmaceutical applications
- Materials science knowledge of polymeric materials for medical devices and familiarity with extractables and leachables studies is desirable
- Experience in managing multiple projects simultaneously
- 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 to carry out projects within defined budget and timelines
- Up to date knowledge of FDA, EMA, USP, Ph.Eur., ISO and WHO requirements as they related to medical device, biologics, and pharmaceutical manufacturing processes
- Excellent verbal and written communication skills including the ability to write technical reports and CMC sections for regulatory submissions
- Ability to clearly communicate complex technical data and principles through oral presentations and written summaries and execute other duties as assigned.
- Experience with sterilization techniques, especially terminal sterilization is a plus.
- Experience with AI, statistical design of experiments (DoE) and multivariate data analysis is a plus
- Up to 25% travel domestically and internationally
We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the selected city is $140,000-$164,000 annually. Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.