Drug Product Development & Manufacturing Manager (hybrid)
Company: Cerus Corporation
Location: Concord
Posted on: November 15, 2024
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Job 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 Concord,
CA 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.
Keywords: Cerus Corporation, Castro Valley , Drug Product Development & Manufacturing Manager (hybrid), Executive , Concord, California
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