Cell and Gene Therapy Associate I

Minaris•Philadelphia, PA

About The Position

Position Summary 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). Essential Functions and Responsibilities Understands aseptic technique concepts Able to operate and maintain equipment Performs solution and material preparation Possesses basic technical knowledge and background Participates on and performs technical transfer activities Assists with the execution of validation activities Receives and organizes materials Identifies and communicates material discrepancies Uses some support systems (e.g. LIMS) Understands the concept of manufacturing processes and methods Collects and records scientific and process data per good document practices Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) Follows and executes Standard Operating Procedures (SOPs). Trains other on basic SOPs, equipment and unit operations Follows and executes Batch Records (BRs). Revises and authorizes simple BRs Participates in the development of technical documents such as non-conforming events and deviations Possess basic computer skills and able to efficiently use basic Microsoft applications Suggests continuous improvement ideas and identifies technical problems Participates on regulatory inspections and client audits Interacts on a minimal basis with groups that support manufacturing Cross trains in other areas and may be utilized to perform above job functions across the entire site Performs well under direct supervision Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Contributes to the overall operations and to the achievement of departmental goals Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures. Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices Other duties as assigned and may be required to assist in other departments Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.

Requirements

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)
High School diploma and over 4 years of relevant experience or Associates’/Bachelor’s (science preferred) degree with over 2 years of relevant or equivalent experience
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence
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
Ability to stand /Sit/walk for long periods of time
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
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

Responsibilities

Responsible for manufacture of Master and Working Cell Banks
Performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs)
Understands aseptic technique concepts
Able to operate and maintain equipment
Performs solution and material preparation
Possesses basic technical knowledge and background
Participates on and performs technical transfer activities
Assists with the execution of validation activities
Receives and organizes materials
Identifies and communicates material discrepancies
Uses some support systems (e.g. LIMS)
Understands the concept of manufacturing processes and methods
Collects and records scientific and process data per good document practices
Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
Follows and executes Standard Operating Procedures (SOPs)
Trains other on basic SOPs, equipment and unit operations
Follows and executes Batch Records (BRs)
Revises and authorizes simple BRs
Participates in the development of technical documents such as non-conforming events and deviations
Possess basic computer skills and able to efficiently use basic Microsoft applications
Suggests continuous improvement ideas and identifies technical problems
Participates on regulatory inspections and client audits
Interacts on a minimal basis with groups that support manufacturing
Cross trains in other areas and may be utilized to perform above job functions across the entire site
Performs well under direct supervision
Regular and reliable attendance on a full-time basis
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned and may be required to assist in other departments
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture