Proclinical is currently recruiting for a Manufacturing Manager with a pharmaceutical company located in Philadelphia, PA.
- Understands, oversees, trains, coaches, mentors and manages performance of others on basic aseptic operational techniques as well as, performing solution, material preparation, analyzing results and facility start-up engineering and mechanical knowledge.
- Understands, teaches and coaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting
- Drives sourcing and purchasing of standard, new and complex equipment
- Reviews and approves solution and material preparation results and resolves issues
- Reviews protocols and other technical transfer documents
- Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
- Forecast and performs material procurement activities
- Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) and/or Super user on a system
- Acts a lead, member or Champion that helps to design the new system or of a systems improvement team
- Trains, coaches mentors and manages 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
- Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific
- Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
- Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
- Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands 'why' behind the regulations
- Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific
- Responsible for ensuring employees are trained on Batch record, SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
- Authors, reviews and approves technical documents such as non-conforming events and deviations
- Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across assigned and site specific programs.
- Plans, monitors, and appraises direct reports including performance competencies, goals & job results
- Coaches, counsels, and conducts disciplinary actions
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
Skills and Requirements:
- HS Diploma or equivalent required and 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
- BS/BA in Science related field preferred; or combination of relevant Experience & Education
- Demonstrated Lean / Six Sigma knowledge, desired.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- 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 Microsoft (Excel, Word, Outlook).
- Must be able to work in Lab setting with Biohazards /various Chemicals.
- Ability to Lift 40 lbs routinely.
- Ability to crouch, bend, twist, and reach.
- Ability to push/pull 40 lbs routinely/ often / occasionally.
- Clarity of Vision and have the ability to identify and distinguish colors.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
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.