Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. Arcellx’s vision is to bring ARC-SparX cell therapies to millions of patients who can self-administer prescribed SparX proteins to treat their cancer under the care of academic and community practices.
Arcellx is looking for an Associate Director of GMP Quality Operations to be responsible for supporting the quality assurance and quality control programs.
Reporting to the Sr. Director of GMP Quality Operations, the Associate Director of GMP Quality Operations will provide day to day quality support to the various Arcellx functions and will be responsible for the administration of quality standards, internal practices and continuous improvement as it relates to internal operations and collaborations with external vendors.
- Represent GMP Quality on project teams and act as a GMP Quality lead for the oversight of all quality aspects performed at manufacturing and testing partners.
- Support Management Quality Reviews and Product Reviews.
- Create, review and approve GMP related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols.
- Co- Lead and co-ordinate investigations, including development and implementation of corrective actions.
- Support internal and external audits.
- Collaborate with cross functional team member to resolve quality issues.
- Prepare Key Performance and Quality Metrics
- Support validation activities related to facilities, equipment, processes, and computerized systems at contract sites.
- Partner with the Sr. Director of GMP Quality Operations in execution of department goals and metrics.
- Communicate and promote a culture of quality and operational excellence at Arcellx
Requirements and Qualifications:
- A Bachelor’s degree in a scientific or technical discipline is required. An advanced degree is preferred.
- A minimum of 10 years of experience in a GxP biotechnology or pharmaceutical environment is required.
- Knowledge and experience in quality assurance and in a highly regulated manufacturing environment.
- Experience working with Contract Manufacturing Organizations.
- Experience developing and implementing Inspection Readiness and PAI Plans.
- Extensive knowledge of US cGMP and GDP compliance regulations and industry practices, as well as EU GMP requirements.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
- Ability to manage multiple priorities and aggressive timelines
- Must have strong organizational skills and an ability to handle track and execute multiple priorities.
- Highly motivated, with willingness to acquire new skills and ability to learn quickly.
- Detail oriented, good documentation practices, technical writing and verbal communication skills
- Possess problem solving and analytical skills and be an independent and creative thinker.
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Interpersonal and leadership skills to work with teams in different functions and organizations.
Submit cover letter and resume to: email@example.com
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.