Manufacturing Associate
: Job Details :


Manufacturing Associate

Randstad Life Sciences US

Location: Andover,MA, USA

Date: 2024-12-24T02:05:15Z

Job Description:

Cell Bank Testing Associate

Duration: 18 month contract

Location: Onsite in Andover, MA

Max Pay Rate: $25.82 - $29.95/hr max

Shift: Monday - Friday / First shift / Possible off shift hours - 100% ONSITE

Job Description

This role is part of the Bioprocess Research & Development Cell Banking team responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical product.

Job 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.

Education & Qualifications

EDUCATION AND EXPERIENCE

Minimum:

  • High School Diploma or GED with 1-3 years of experience in a biotechnology manufacturing or laboratory environment.

Preferred:

  • 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.
Apply Now!

Similar Jobs (0)