Manufacturing Associate

Manufacturing Associate at Planet Pharma Manufacturing Associate at Planet Pharma in Pacifica, California Posted in 7 days ago.

Type:

full-time

Job Description:

Manufacturing Associate needed!

Overview:

Support the daily GMP manufacturing operations of allogeneic NK cell therapies while driving facility and equipment qualifications, initiating and assessing deviations, reviewing batch records, and authoring SOPs.

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.