Job Details

Looking for multiple levels of I/II/Sr.

Responsibilities:

• Supports technical transfer of new products/processes by collaborating with other members of the CMC team (PD, MSAT, Quality, Supply Chain, etc.).
• Supports in setting up manufacturing areas and equipment/fixtures. Performs facility and equipment/environmental monitoring activities.
• Performs manufacturing processes on the floor, following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.
• Ensures right-the-first-time performance of all process steps specific to the phase or stage of operation.
• Completes training assignments to ensure the necessary technical skills and knowledge.
• Works as part of a team to execute GMP runs in close collaboration with other areas of CMC.
• Performs Aseptic Filling unit operations for the manufacture of products in a cGMP environment using proper aseptic technique, good documentation practices, and sound scientific methods.
• Operates automated filling equipment and the execution of the manufacturing processes from filling to cryopreservation of product using batch records.
• Rigorously adheres to SOPs and cGMP regulations and accurately completes documentation associated with clinical manufacturing.
• Supports development of SOPs, MBRs, and other process documents, as well as deviations and change controls.
• Escalates processing and equipment issues as needed.
• Reviews daily in-process cGMP documentation for completeness and accuracy
• Participates in any operational excellence initiatives such as 5S, Kaizen, lean manufacturing and continuous improvement
• Embodies the company culture of empowerment, diversity, and inclusion.

Qualifications:

• Knowledge of the current Good Manufacturing Practices (cGMP's).
• Knowledgeable in Microsoft Word, Excel and data analysis.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills.
• Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment.
• Able to work off shift hours and weekends.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Preferred Excellent aseptic/sterile techniques and prior experience with biopharmaceutical manufacturing; previous experience with cell or gene therapy manufacturing.

Education/Background

• Accepting all experience levels. Position level will be adjusted to match. 2 years or more years of experience in cGMP biologics cell culture manufacturing, experience in biotech or cell therapy manufacturing with a bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education preferred