Cell Bank Testing Associate

2 days ago

Andover, United States Synectics Full time

Job Description:

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

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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