Translational Research & cGMP Manufacturing Associate

Our client is making a significant impact in the Cell Therapy realm. They are a clinical-stage biotech company whose cell products show early success with multiple myeloma, ALS, and solid tumors. As part of the team, you’ll discover meaningful work that positively impacts people’s lives. Join us in our endeavor to combat severe ailments such as ALS, Multiple Myeloma, and Solid Tumors, as we strive to achieve our mission.

Summary:

The main objective of the role as a Translational Research & cGMP Manufacturing Associate is to acquire practical knowledge by participating in the production/manufacturing of clinical cell therapy treatments and research and development (R&D) projects, which includes contributing to intricate, specialized, and time-critical testing procedures.

Responsibilities:

• Utilize all accessible resources to attain the department's objectives.

• Hold oneself accountable for outcomes and take charge of decisions rendered.

• Demonstrate the ability to consistently adhere to manufacturing batch records, work instructions, and/or standard operating procedures (SOPs) on a daily basis, emphasizing proactive and accurate initial executions.

• Aid in the completion of batch records and associated documentation.

• Carry out all manufacturing tasks within a controlled environment (ISO 7 clean room and biological safety cabinet) while adhering to specialized sterile gowning protocols. This may require extended periods of work in a cleanroom environment based on production demands.

• Conduct cell therapy manufacturing and cell processing tasks using closed systems, maintaining aseptic techniques throughout the processing to guarantee the utmost quality, viability, and sterility of the cellular product until release.

• Collaborate as a team member to fulfill all essential Good Manufacturing Practice (GMP) responsibilities for cell manufacturing with precision and promptness.

• Accurately perform calculations of cell concentrations, cell and media dilutions, and cell viability throughout the entire cell manufacturing/R&D process workflow without errors.

• Competently manage all departmental functions, including upkeep of cGMP-designated areas/laboratories, inventory, supplies, equipment, logbooks, and data, aligning with site-specific SOPs and policies.

• Manage inventory receiving and ordering reagents.

• Exhibit proficiency in analyzing and interpreting test findings.

• Adhere to cGMP cleanroom requirements and FDA regulations.

• Thoroughly document all activities to fulfill cGMP requisites.

• Participate in the creation and assessment of documentation such as writing protocols, SOPs, and creating technical reports.

• Promptly record material consumption and ensure completion of quality documentation in designated systems.

• Dismantling, reassembling, and cleansing manufacturing equipment within the designated area for compounding readiness.

• Participate in routine lab operations (lab maintenance, safety inspections, equipment prevention/maintenance, and other related duties.

• Ensure data integrity and maintain compliance with general laboratory operations, all appropriate protocols and/or SOPs for laboratory work, data recording, and laboratory instrumentation.

Qualifications:

• Bachelor’s degree in a technical STEM field is preferred, however, will consider the candidates with an associate's degree or High School diploma with equivalent experience and an ability to learn.

Additional Qualifications and Relevant Experiences:

• Preferably 0-2 years of experience in cGMP manufacturing/production, with a valuable addition being experienced in cell therapy.

• Combinations of equivalent education, training, and pertinent work history will be taken into consideration.

• Highly desirable to have familiarity with cell culture procedures under a biological safety cabinet.

• Highly desirable, but not required, to have experience with flow cytometry, Sepax, and Luminex, understanding/background in immunology and cellular biology including mammalian cell culture, and performing the experiments.

• Possesses a strong quality-focused mindset with meticulous attention to detail, particularly concerning documentation review and completion.

• Capable of identifying issues with machinery or processes with excellent critical thinking and problem-solving abilities.

• Proficient in multitasking, adept at following intricate instructions for conducting compounding tasks.

• Familiarity with appropriate training plans and departmental protocols, including those related to equipment, processes, equipment setups, and changeovers.

• Demonstrates consistent achievement through proactive initiation, organizational adaptability, effective planning, and strategic prioritization.

• Tackles complex challenges by comprehending and troubleshooting problems, establishing explicit priorities and guidance, and engaging and aligning internal as well as external resources.

• Self-motivated, enthusiastic, and driven, exhibits a collaborative work ethic to uphold productivity and efficiency.

• Displays punctuality and a strong sense of duty by adhering to departmental attendance guidelines.

• Effective communication skills both within and between teams.

• Exhibiting proficiency in offering constructive feedback and being receptive to receiving and effectively acting upon input.

• Ability to work independently and within a team-oriented fast-paced collaborative environment with a positive mindset and approach.