Production Specialist

Job Description

• Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion,

Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will work

seamlessly across all areas and will be an SME for multiple areas.

• Leads new products introductions (NPIs) into CCTC with support from biological

development (BD) and tech transfer teams (MSAT). Ensures all activities are tracked and

performed to schedule.

• Actively collaborates with BD and MSAT to ensure cross functional alignment with platform

process, equipment, raw materials and/or automation.

• Manufactures products in various phases of product life cycles from clinical thru launch.

Clearly understands, communicates, and manages complexity in terms of documentation,

sample handling, automation and cGMPs etc. for different phases of product life cycle.

• Manages, handles and troubleshoots single use technology (SUT) from end to end in

manufacturing process.

• Monitors and controls all aspects of manufacturing processes using data trending and /or

statistical process control. Works cross functionally to ensure process is controlled and issues

are escalated and investigated.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Manufacturing Experience: Hands-on experience working on a manufacturing floor ideally with exposure to downstream development processes.

• GMP and GDP: Experience with GMP processes, familiarity with SAP, and capability to handle 12-hour shifts

• Experience with Cell Therapy

• Documentation: Experience with Batch Production Records (BPRs), SOPs, and log books, including:

• Experience with Batch Production Records (BPRs), SOPs, and log books.

• Ensure candidates know that if procedures aren’t followed, they are required to initiate and document deviations according to GDP standards.

• Experience preparing labels, filling out documentation, and reviewing logbooks accurately in a GDP-compliant manner.