Proclinical is currently recruiting for a Manufacturing Supervisor with a global pharmaceutical company located in Philadelphia, PA. As the Manufacturing Supervisor, you 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 and Gene Therapy products.
- Understand, oversee, train, coach, mentor and manage performance of others on basic aseptic operational techniques as well as, perform solution, material preparation, 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 is able to perform complex troubleshooting.
- Drive sourcing and purchasing of standard, new and complex equipment.
- Review and approve solution and material preparation results and resolves issues.
- Review protocols and other technical transfer documents.
- Identify and drive application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer.
- Execute in-house and offsite validation activities.
- Forecast and performs material procurement activities.
- 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.
- Interpret data and draws conclusions.
- Identify process and method gaps and opportunities and implements improvements across assigned programs and site specific.
- 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.
- Follow compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understand 'why' behind the regulations.
- Identify, suggest, participate, lead, implement, and champion continuous improvement ideas.
- Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across assigned and site-specific programs.
- Regularly interact with and support cross-functional teams.
- Accomplish staff results by communicating updated organizational information, job expectations & supporting their work.
Skills and Requirements:
- 5+ years relevant technical experience and 2+ years in a Lead/Leadership/Supervisory Role.
- BS/BA in Science related field preferred; or combination of relevant experience and education.
- Demonstrated Lean / Six Sigma knowledge, desired.
- Ability to perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations accurately and reproducibly.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- Has basic financial knowledge and acumen.
- Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding.
- Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.
- Proficient in Oral & Written communication skills.
- Need to be able to read, write and understand English.
- Proficient in Microsoft (Excel, Word, Outlook).
If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at (+1) 215-531-5280 or firstname.lastname@example.org.
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.