Overview

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).

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 practice
• Trains, coaches, mentors front line management and manages performance of 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 across site specific programs
• Able to operate and maintain equipment
• Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues
• 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
• First line decision maker for equipment issues
• Trains, coaches, mentors front line management and manages performance of others performing solution and material preparation, analyzing results and resolving issues
• Reviews and approves solution and material preparation results and resolves issues
• First line decision maker for solution and material preparation issues
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically 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 engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and endto-end understanding
• Trains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding
• Possesses basic and fundamental facility start-up experience
• Trains, coaches, mentors others on facility start-up
• Has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across site specific programs
• Provides input into facility design and works with team to make decisions on design
• Participates on and performs technical transfer activities
• Trains, coaches, mentors and manages performance of technical transfer activities
• Provides feedback for facility fit
• Reviews and approves 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 across the site during phases of technical transfer
• Executes in-house and offsite validation activities
• Trains, coaches, mentors and manages performance of validation activities
• Provides input, reviews and approves validation documents
• Has working knowledge of validation requirement
• Identifies validation gaps and needs across site specific programs
• Trains, coaches and manages performance of scheduling, receipt and organization of materials
• Forecast and performs material procurement activities
• Reviews and finalizes material documents
• Approves CS forms
• Approves change controls for new material implementation
• Identifies, communicates and resolves material discrepancies
• Possess awareness for all support systems (e.g. LIMS)
• Trains, coaches, mentors and manages performance of others use of support systems
• Acts a lead, member, Champion or Sponsor 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
• Trains, coaches, mentors front line management and manages performance of manufacturing processes and methods ensuring compliance with standards
• Trains, coaches, mentors front line management and manages performance of others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems across site specific programs
• Interprets data and draws conclusions
• Identifies, understands, trains, coaches, mentors front line management, manages performance 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 across site
• 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 train, coach, mentor, mentors front line management and manage performance of others
  to do the same
• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across site
• Follows and executes Standard Operating Procedures (SOPs)
• Trains, coaches, mentors front line management and manages performance of others who execute SOPs
• Revises, authors and reviews simple and complex SOPs
• Standardizes and aligns SOPs
• Improves the efficiency and execution of SOPs
• Reviews and approves SOPs
• Trains, coaches, mentors front line management and manages performance of others who execute BRs
• Improves the efficiency and right-first-time (RFT) of BR execution
• Standardizes and aligns BRs
• Reviews and approves BRs
• Accountable for ensuring front line management ensure associates are trained on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
• Communicates training needs
• Makes suggestions to the training program
• Authors, reviews and approves technical documents such as non-conforming events and deviations
• Teaches, coaches, mentors front line management and manages performance of others participating, providing information and authoring technical documents
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates, leads, implements and sponsors continuous improvement ideas
• Teaches, coaches and mentors front line management of others to identify, suggest, participate and lead continuous improvement ideas
• Identifies, participates, suggests solutions and leads complex technical problem solving
• Teaches, coaches and mentors others to solve technical problems
• First line decision maker for technical problems
• Identifies, suggests with options, recommends path forward and leads complex decision making sessions
• Teaches, coaches and mentors front line management on how to make decisions
• First line decision maker for issues that require decisions
• Delegates work assignments
• Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across site specific programs and site
• Teaches, coaches and mentors front line management to delegate, prepare the schedule and how to make adjustments to assign and perform work
• Participates, supports, assists as an SME, leads, resolves conflict, presents and represents during regulatory inspections and client audits
• Regularly interacts with groups that support manufacturing
• Identifies and works to resolve issues and relations with groups that support manufacturing
• Coordinates, deals with problems and is the first line manufacturing decision maker with groups that support manufacturing in a cross functional manner
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Has basic financial knowledge and acumen
• Delivers performance efficiencies to impact assigned program and site specific programs, department and site gross margin
• Performs well under direct supervision and works independently on complex tasks and processes
• Manages the manufacturing process, projects and people
• Train, coaches and mentors front line management on how to lead and oversee manufacturing processes
• Accountable for departmental and performance management
• Regularly holds 1:1s with direct reports and skip level meetings
• Regularly holds staff meetings
• Identifies and prioritizes escalations
• Evaluates, recommends and makes decisions on hires, transfers, promotions and discharges
• Demonstrated Lean / Six Sigma knowledge desired
• 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

Qualifications

Education:

• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years Managing people
• BS/BA in Science related field preferred; or combination of relevant Experience &
  Education

Knowledge / Skills / Abilities:

• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.
• Holiday and shift work often required based on manufacturing schedule as determined by Management.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)