Job Title: Clinical-Scientific - Research Associate
Location : Onsite
Duration : 19+ months
Position summary:
- This role is part of client's Bioprocess Research & Development Cell Banking team responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical product.
Position 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 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.
Schedule: Monday - Friday / First shift / Possible off shift hours (not OT)