Job Description
About the Role - The Lead Manufacturing Associate is responsible for 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).
Responsibilities
- Understands aseptic technique concepts
- Oversees and monitors overall performance of aseptic technique ensuring compliance with standards
- Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
- Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practices
- Trains, coaches and mentors others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting and overall systems and operations
- Identifies aseptic technique gaps and opportunities and implements improvements
- Able to operate and maintain equipment
- Understands and determines maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues
- Coordinates complex corrective maintenance
- Understands all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting
- Supports sourcing and purchasing of standard, new and complex equipment
- Performs solution and material preparation, analyzing results and resolving issues
- Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
- Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end expertise
- Possesses basic and fundamental facility start-up experience
- Has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate and overseeing
- Participates on and performs technical transfer activities
- Provides feedback for facility fit
- Helps with application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
- Executes in-house and offsite validation activities
- Provides input and reviews validation documentation
- Schedules, receives and organizes materials
- Performs material procurement activities
- Creates and revises material documents
- Creates CS forms
- Identifies, communicates and resolves material discrepancies
- 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 multiple systems
- Acts a member or Champion that helps to design the new system or of a systems improvement team
- Understands the concept of and has performed or experience with manufacturing processes and methods
- Oversees and monitors overall performance of manufacturing processes and methods ensuring compliance with standards
- Trains, coaches and mentors others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems
- Identifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make on the spot corrections to performance
- Identifies process and method gaps and opportunities and implements improvements
- 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. Able to coach and mentor others to do the same
- Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues
- Follows, executes, authors, and improves the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
- Trains others on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
- Participates, provides information in the development, authors and reviews technical documents such as non-conforming events and deviations
- Possess basic computer skills and able to efficiently use basic Microsoft applications
- Suggests, participates, leads and implements continuous improvement ideas
- Identifies, participates, suggests solutions and leads complex technical problem solving
- Identifies, suggests with options, recommends path forward and leads complex decision making sessions
- Delegates work assignments
- Accountable for schedule preparation, adjustments and performance of work assignments for team
- Participates, supports, assists as an SME, presents and represents during regulatory inspections and client audits
- Cross trains in other areas and may be utilized to perform above job functions across the entire site
- Performs well under direct supervision and works independently on complex tasks and processes
- Leads and oversees the manufacturing process
Requirements:
High School diploma and over 8 years of relevant experience OR
Associates’/Bachelor’s (science preferred) degree with over 5 years of relevant or equivalent experience
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