Production Manager
Not Disclosed•Full-TimeOn-site
location_onSTAR Arts Education, 7393, Monterey Street, Gilroy, Santa Clara County, California, 95020, United States
About the Role
The Production Manager for Radiopharmaceutical Contract Manufacturing serves as the operational leader for our site's aseptic and GMP production activities. This role is critical to ensuring the timely manufacture and delivery of diagnostic and therapeutic radiopharmaceuticals that meet rigorous customer expectations and regulatory standards.
In this position, you will oversee the full lifecycle of production, from the transfer of established manufacturing processes and new product development to clinical and commercial manufacturing campaigns. You will lead the RCM production and cleaning teams, managing resources, materials, and schedules to drive efficiency while maintaining the highest standards of quality and safety.
Team Context & Mission
Operating within SOFIE's framework, this role ensures that all radiopharmaceuticals are produced in full compliance with cGMP guidelines, including 21 CFR 211/212 and EudraLex Volume 4. The Production Manager acts as a bridge between the production floor and cross-functional teams, including Quality Assurance, Regulatory Affairs, and Environmental Health & Safety. The mission is to deliver safe, effective, and compliant drug products while fostering a culture of continuous improvement, safety, and operational excellence.
Day in the Life
Your day will involve a dynamic mix of leadership, technical oversight, and hands-on participation. You will lead by example, participating in manufacturing activities as needed, while also managing the performance and development of direct and indirect reports through regular 1:1s and staff meetings. A significant portion of your time will be dedicated to ensuring aseptic operations comply with internal procedures and industry practices, reviewing clinical dose manufacturing plans, and approving batch records and labels.
You will collaborate closely with Microbiologists and QA to investigate deviations, initiate CAPA plans, and manage change controls. Additionally, you will oversee radiation safety protocols, ensuring ALARA principles are maintained and that personnel training and qualification requirements for ISO classified areas are met. The role requires flexibility to work various shifts and weekends to support production needs.
Hiring Process
Candidates selected for this role will engage in a structured interview process designed to assess technical expertise in radiopharmaceutical manufacturing, leadership capabilities, and cultural fit. The process typically includes an initial screening, followed by in-depth technical and behavioral interviews with the hiring team and cross-functional partners.
Equal Opportunity Employer
SOFIE is an equal opportunity employer committed to building a diverse and inclusive workforce. We consider qualified applicants regardless of background, race, color, religion, gender, sexual orientation, age, disability, or veteran status.
Similar Job Opportunities
Skills, education and keywords
Skills: CGMP, Aseptic Process, Lean Six Sigma, MS Office Suite, Radiation Safety, Equipment Qualification, Cleanroom Environment, Capa, Change Control, Lean Tools.
Education: Bachelor's degree in a scientific field required; Master's degree preferred.
Frequently asked questions about Production Manager at SOFIE
What does a Production Manager at SOFIE do?expand_more
Day-to-day, the Production Manager at SOFIE will lead and implement the transfer of manufacturing processes and procedures for new radiopharmaceuticals; schedule and supervise clinical and commercial manufacturing activities to ensure full compliance; manage and supervise the rcm production and cleaning team including shift leads and supervisors; and review and approve clinical dose manufacturing plans, labels, batch records, and associated em data.
What are the requirements for this Production Manager role?expand_more
To qualify for the Production Manager at SOFIE position, applicants should have: Bachelor's degree in a scientific field; 10+ years of experience in radiopharmaceutical/pharmaceutical drug product manufacturing and production equipment management; 3-5 years of people management experience; Familiarity with radiation protection and safe handling of radioactive materials; Knowledge of cGMP requirements, aseptic process, and equipment qualification; and Efficient in the use of MS Office Suite.
Where is the Production Manager role at SOFIE located?expand_more
Production Manager at SOFIE is based in STAR Arts Education, 7393, Monterey Street, Gilroy, Santa Clara County, California, 95020, United States. This is a on-site role.