System One

Job Title: Cell Bank Testing Associate

Location: Andover, MA

Hours/Schedule: Monday - Friday; First shift 

Type: Contract

Responsibilities

• Conduct cell bank manufacturing operations as required. Follow and adhere to cGMP documentation practices, operational procedures, and compliance procedures.
• Perform cell bank distribution and shipping activities, as required.
• Adhere to safety procedures and guidelines by practicing and promoting safe work habits.
• Review and Archive GMP documents [SOPs, master batch records and campaign summary reports].
• Maintain cell banking facility and equipment in a constant state of operational and audit readiness.
• Collaborate with partners from diverse cross-functional lines to effectively resolve events and issues.
• Understand scientific principles in order to identify and solve moderately complex problems.
• Make sound and compliant decisions with minimal input that may require choosing from limited options.
• Think critically and facilitate the drive towards continuous improvement.
• Effectively manage own time and balance workload priorities.

Requirements

• High School Diploma or GED with 1-3 years of experience in a biotechnology manufacturing or laboratory environment.
• Bachelor's degree in biology or related scientific discipline with 1-3 years of relevant experience

TECHNICAL SKILLS REQUIREMENTS

Must-Have

• Knowledge of mammalian cell culture and/or microbial fermentation processes.
• Operational knowledge of computerized systems.
• Ability to follow Standard Operating Procedures and work under minimal supervision.
• Understanding of scientific principles, ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Strong interpersonal, teamwork, and collaboration skills with the ability to work in a complex, multi-discipline organization under minimal supervision.
• Excellent oral and written communication skills.
• Strong computer skills in Microsoft Office required, especially MS Word, MS Excel.

Nice-to-Have

• Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting.
• Familiarity with business systems (e.g. Document Management Systems, LIMS, SAP, electronic Notebook, etc.)
• Experience in mammalian and microbial cell culture in a GMP setting with strong aseptic technique.
• Experience in cGMP compliance and regulatory compliance requirements as related to manufacture of biologics

PHYSICAL POSITION REQUIREMENTS

• Must be able to gown into cleanroom environment and be standing for ~1-2 hours at a time.
• Must be able to manipulate screw-cap vials inside a BSC and aseptically fill at least 200 vials in a single setting.
• Must have practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site.
• Must be able to gracefully manage non-ideal situations under stress.
• Must have a change-agile growth mindset for navigating changing needs and priorities.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.