Responsible for building and supervising a team of manufacturing trainers and training coordinator(s) who coordinate, schedule, design, provide, document, maintain and improve training for all manufacturing personnel on matters including but not limited to: new hire orientation, department and facility specific training.

• Understands aseptic technique concepts
• Oversees and monitors overall performance of aseptic technique ensuring compliance with standards
• Able to identify unacceptable aseptic practices and make spot corrections to performance
• Trains, coaches, mentors and manages performance of others on basic aseptic operational techniques of overall systems and operations
• Ideally, trains, coaches, mentors and manages performance of others on basic aseptic operational techniques of process specific unit operations
• Understands, teaches and coaches others on basic operations, functions, capability of equipment and ancillary support to equipment and is able to perform basic troubleshooting
• Understands and manages such that operator level maintenance requirements (preventative and calibration) of equipment and may work with vendor to resolve issues
• First point of escalation for equipment issues
• Trains, coaches, mentors and manages performance of others performing solution and material preparation, analyzing results and resolving issues
• First point of escalation for solution and material preparation issues
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, ideally in cell and gene therapy
• Trains, coaches and mentors others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
• Possesses basic and fundamental understanding of technical transfer
• Has working knowledge of validation requirements
• Identifies validation gaps and needs
• Trains, coaches, mentors and manages performance of validation activities
• Schedules, forecasts receives and organizes materials
• Identifies, communicates and resolves material discrepancies
• Performs material procurement activities
• Reviews and finalizes material documents
• Able to train, mentor, mentor and manage trainees on performance of material related activities
• First line decision maker on items of escalation for material related activities
• Trains, coaches, mentors and manages performance of others use of support systems
• Uses all support systems (e.g. LIMS) with some proficiency
• Understands the concept of manufacturing processes and methods
• Trains, coaches, mentors and manages performance of others on basic operations such as media preparation, thaw, passage and harvesting
• 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.  Able to train, coach, mentor and manage performance of others to do the same
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.  Able to train, coach, mentor and manage performance of others to do the same
• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across site

• Accomplishes staff results by communicating updated organizational information,  job expectations & supporting their work
• 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

• Ability to work in a team environment and independently as required
• Must be able to work cross functionally
• May be required to work Holidays and weekends
• May be required to work Overtime

• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Advanced Therapies and Standard Operating Procedures.

• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Works on special projects as needed
• Other duties as assigned

Education/Experience:

• 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

Knowledge, Skills and Abilities:

• Experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required
• Experience with laboratory and/or manufacturing instruments/equipment
• Experience building a training program and curriculum
• Experience in developing, conducting and evaluating training
• Strong leadership skills including project management skills
• Experience with the end-to-end learning process
• Must be flexible and able to manage multiple priorities while working within a matrixed stakeholder environment.
• Effective verbal and written communication skills
• Ability to work under limited supervision and to handle problems of a more difficult nature.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
• Holiday and shift work may be required based on manufacturing schedule as determined by Area Management.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions. Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 20 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 20 lbs routinely/ often / occasionallyClarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.