Proclinical is seeking a Lead Manufacturing Associate who will be responsible for the production of M&W Cell Banks. The role also involves supporting the manufacturing of Cell & Gene Therapy products and final product fills in accordance with current Good Manufacturing Practices (cGMPs).
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Oversee and monitor aseptic technique performance, ensuring compliance with standards.
- Train, coach, and mentor others on basic aseptic operational techniques.
- Operate and maintain equipment, coordinating complex corrective maintenance when necessary.
- Support sourcing and purchasing of standard, new, and complex equipment.
- Perform solution and material preparation, analyzing results and resolving issues.
- Participate in facility start-ups and lead subteams when required.
- Perform technical transfer activities and provide feedback for facility fit.
- Execute in-house and offsite validation activities and review validation documentation.
- Schedule, receive, and organize materials, performing material procurement activities.
- Use all support systems with demonstrated proficiency and act as a subject matter expert on multiple systems.
- Oversee and monitor overall performance of manufacturing processes and methods, ensuring compliance with standards.
- Identify, communicate, address, and improve complex cGMP compliance and regulatory gaps and issues.
- Follow, execute, author, and improve the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs).
- Participate, provide information in the development, author, and review technical documents such as non-conforming events and deviations.
- Suggest, participate, lead, and implement continuous improvement ideas.
- Delegate work assignments and prepare schedules for the team.
- Participate, support, assist as an SME, present and represent during regulatory inspections and client audits.
- Cross-train in other areas and perform job functions across the entire site.
- Lead and oversee the manufacturing process.
Key Skills and Requirements:
- Understanding of aseptic technique concepts.
- Ability to operate and maintain equipment.
- Technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.
- Basic and fundamental engineering and mechanical knowledge.
- Basic and fundamental facility start-up experience.
- Proficiency in using support systems.
- Understanding of manufacturing processes and methods.
- Ability to follow compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs).
- Basic computer skills and efficient use of basic Microsoft applications.
- High School diploma and significant relevant experience or Associates'/Bachelor's degree (science preferred) with relevant or equivalent experience.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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