Research Associate

Job Description: POSITION SUMMARY:
This role is part of *** 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.

ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
Cell Bank testing team
*** QA
PharmSci Cell Bank team
*** shipping and logistics teams
*** calibration and validation colleagues

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.

Hard Skills:
1. Knowledge of mammalian cell culture and/or microbial fermentation processes.
2. Operational knowledge of computerized systems.
3. Ability to follow Standard Operating Procedures and work under minimal supervision.

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

Interview Process:
1st Teams Bridge Phone interview
2nd Panel Teams (camera on)
Position Comments visible to Supplier: Please be sure to review the entire JD along with PHYSICAL POSITION REQUIREMENTS