Bioprocessing Associate I

Overview

Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need. Working at Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. Our benefits include:

• 401K matching
• PTO
• Employee discount programs
• Medical, dental and vision insurance
• and much more

The Bioprocessing Associate I is responsible for providing support in performance of activities within production facilities to support manufacture of Master and Working Cell Banks Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). 

Responsibilities

• Participates on and performs technical transfer activities
• Assists with 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
• Supports design of aseptic operational techniques such as media preparation, thaw, passage, harvesting and overall systems and operations
• Understands aseptic technique concepts and has performed aseptic technique
• Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practices.
• Able to identify unacceptable practices, make spot corrections to performance and implement improvements.
• A point of escalation for technical problems, equipment issues, and solution and material preparation issues
• Identifies and prioritizes escalations
• Able to operate and maintain equipment, and coordinate corrective maintenance
• Understands maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues.
• Understands and teaches others on operations, functions, capability of equipment and ancillary support to equipment and is able to perform troubleshooting.
• Trains others on SOPs, equipment, unit operations and non-manufacturing SOPs and systems and makes suggestions to the training program
• Drives and assists with sourcing and purchasing of standard and new equipment
• Participates and possesses basic fundamental facility start-up experience
• Provides input into facility design and feedback for facility fit
• Has working knowledge of validation requirements.
• Provides input and executes validation documents and supports validation activities
• Identifies validation gaps and needs across assigned programs
• Identifies, participates, suggests solutions, and leads basic technical problem solving
• Teaches, coaches and mentors others to solve basic technical problems
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
• Authors, revises, and assists others on technical documents
• Owns and supports basic change controls and action items
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Policies and Standard Operating Procedures.
• Uses all support systems (e.g. LIMS) with demonstrated proficiency
• Trains others on the use of support systems
• Revises, authors, standardizes and aligns simple and complex SOPs and BRs to improve efficiency in execution
• Improves the efficiency and right-first-time (RFT) of BR executions
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.
• Collaborates with Quality Assurance to support overall performance and drive improvements of manufacturing processes and methods ensuring compliance with
• Identifies, communicates, addresses and improves simple cGxP compliance and regulatory gaps and issues across site specific assigned programs
• Delivers performance efficiencies to impact assigned program and site specific departmental gross margin
• Supports performance of scheduling, receipt and organization of materials.
• Support and prepare metrics/KPIs as a means to drive improvement of performance
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Understands engineering and mechanical knowledge and how to apply to manufacturing area for unit operations
• Reviews solution and material preparation results and resolves issues
• Participates, supports, assists, and resolves conflict during regulatory inspections and client audits
• Performs basic collection, analysis, interpretation, draws conclusions and identifies trends of scientific and process data per good document practices
• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific programs
• Understands the concept of and has performed or experience with manufacturing processes and methods
• Performs well under minimal supervision and ability to work independently on basic tasks and processes
• Supports the manufacturing process and projects.
• Identifies, suggests, participates and implements continuous improvement ideas
• Acts as a member of a team that helps to design a new system or a systems improvement
• Interacts and coordinates frequently with support groups
• Has basic financial knowledge and acumen.
• Possess basic computer skills and able to efficiently use Microsoft applications.
• Possesses lean/six sigma knowledge and experience
• May be required to work outside normal business hours, overtime, holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals
• Thorough understanding of Good Laboratory Practices, Good Manufacturing Practices, and Good Documentation Practices
• Other duties as assigned
• Supports GMP operations directly as needed.
• May be required to assist in other departments

Qualifications

Experience / Education:

• HS Diploma or equivalent required and 1-2 years technical experience, or AS/BS

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.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
• 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).

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with exposure to Animals / Biohazards / 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, push/pull 40 lbs. routinely/ often / occasionally.
• Ability to crouch, bend, twist, and reach.
• Clarity of Vision.
• 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.

Advanced Therapies provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.