- Perform and/or verify all tasks associated with the manufacture of cell therapy products following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.
- Work as part of a team to execute GMP production runs in close collaboration with Materials Management, Quality Control and Quality Assurance.
- Perform set-up, operation, cleaning, basic maintenance, and breakdown of simple/routine equipment as per applicable SOPs.
- Draft new and revise existing manufacturing batch records/SOPs/work instructions to support process improvements and maintain cGMP compliance.
- Work in a cleanroom environment that will require a gowning process.
- Raise processing and equipment issues in timely manner to manufacturing management and actively participate in troubleshooting.
- Participate in technology transfers with CBMG internal groups.
- Complete required training assignments to maintain necessary technical skills, and knowledge and to ensure compliance with cGMP requirements.
- Assist in the development of SOPs and batch records.
- Maintain appropriate inventories of materials and supplies within the cleanroom areas to support manufacturing activities.
- Weekend work required.
- Other duties as assigned.
- Bachelor's degree, preferably in biology or other related disciplines. Or Associate Degree with 1+ years of related working experience. Or High School Diploma or GED with 3+ years of related experience
- More than 1+ years of GMP experience is preferred; pharmaceutical, biotechnology or other similar manufacturing environments are preferred.
- Previous training and experience in cell culture, aseptic technique or operations in a biology lab is preferred.
- Experience handling and culturing live cells, including T cells is preferred.
- Rigorous adherence to SOPs and cGMP regulations with the ability to accurately complete documentation associated with the manufacturing process in a timely fashion is required.
- Skilled with Microsoft Office suite of products.
- Ambitious and willing to accept temporary responsibilities outside of initial job description.
- Comfortable in a fast-paced small company environment, able to adjust workload based on changing priorities.
- Join a high-growth and fast-paced organization.
- Defined career path and annual performance review and feedback process.
- Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more
- Competitive company 401k match.
- Paid holidays, sick leave, and annual leave.
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Sr Associate/Associate, Cell Therapy Manufacturing - Rockville, United States - AbelZeta Inc
Description
Job Description
Job DescriptionAbelZeta is a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients. We are seeking a Manufacturing Associate to join the Technology & Manufacture team.Responsibilities and Duties:
Qualifications and Requirements:
Why You Should Join AbelZeta
AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta's total compensation package for employees.
