Proclinical is recruiting for a Manufacturing Supervisor for a global pharmaceutical company located in Philadelphia, PA. Successful candidate will be responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
- Understand, oversee, train, coach, mentor and manage performance of others on basic aseptic operational techniques as well as, perform solutions, prepare materials, analyze results and facility start-up engineering and mechanical knowledge.
- Understand, teach and coach others on all operations, functions, capability of equipment and ancillary support to equipment and able to perform complex troubleshooting.
- Review protocols and other technical transfer documents.
- Identify and drive application of GMP concepts and able to recommend and identify improvements as the process develops during phases of technical transfer
- Execute in-house and offsite validation activities.
- Forecast and perform material procurement activities
- Use all support systems (e.g. LIMS) with demonstrated proficiency and act as a subject matter expert (SME) and/or Super user on a system.
- Act as lead, member or Champion to help design the new system or of a systems improvement team.
- Train, coach mentors and manage performance of others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems across assigned programs, in the manufacturing process.
- Collect, record, review, perform analysis, interpret, identify trends of scientific and process data per good document practices.
- Communicate with internal and external stakeholders scientific and process data and recommend path for forward processing.
- Identify, communicate, address and improve complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific.
- Ensure employees are trained on Batch record, SOPs, equipment, all unit operations and non-manufacturing SOPs and systems.
- Author, review and approve technical documents such as non-conforming events and deviations.
- Accountable for schedule preparation, forecasts, adjustments and performances of work assignments for team to ensure adequate staffing across assigned and site-specific program.
- Plan, monitor, and appraise direct reports including performance competencies, goals & job results.
Skills and Requirements:
- HS Diploma or equivalent required. BS/BA in Science related field preferred; or combination of relevant Experience & Education.
- 5+ years' relevant technical experience and 2+ years in a Lead/Leadership/Supervisory Role.
- Excellent oral and written communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mike Raletz at (+1) 267-428-7770 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.