Pioneer Data Systems
Bioprocess Technician / Cell Culture
Pioneer Data Systems, Andover, MA, United States
Position Details:
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Bioprocess Technician to join their expanding team.
Job Title: Bioprocess Technician / Cell Culture
Duration: 18 months contract, extendable up to 36 months
Location: Andover, MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Cell Bank Technician
Summary:
This role is part of Clients Bioprocess Research & Development Cell Banking team responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical product.
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
Minimum Qualifications:
High School Diploma or GED with a minimum of 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 preferred
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.
Preferred Qualifications:
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
Workplace 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.
Location/Schedule:
This is a fully onsite role in Andover, MA
Monday - Friday; first shit (possibility for off shift hours)