Director/Sr. Director, GMP Quality Operations

Location
Gaithersburg, MD
Posted
Aug 04, 2021
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Arcellx 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 platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices.

Primary Objective:

  • Arcellx is looking for a Director/Sr. Director of GMP Quality Operations responsible for managing quality assurance and quality control programs, reporting to the VP of Quality. The Director/Sr. Director of GMP Quality Operations will manage all GMP quality programs and continuous improvement as it relates to internal operations and collaborations with external vendors.
  • While being in compliance with current Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP), the Director/Sr. Director of GMP Quality Operations will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.

Main Accountabilities:

  • Develop and implement programs that support Arcellx's GMP-regulated activities to ensure compliance with applicable regulatory requirements and internal procedures.
  • Lead the GMP Vendor Management and Oversight Program including: developing audit schedule, performing vendor audits, and creation of quality agreements.
  • Represent Quality on project teams and act as the GMP Quality lead for the oversight of all Quality aspects performed at manufacturing and testing partners.
  • Lead Management and Product Reviews.
  • Review and approve GMP related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols.
  • Prepare Key Performance and Quality Metrics
  • Support validation activities related to facility, equipment, processes and computerized systems at contract facilities.
  • Partner with the VP of Quality in creation 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 15 years of experience in a GxP in biotechnology or pharmaceutical environment is required.
  • Leadership experience in building high performing teams.
  • Experience in 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.
  • Strong leadership and management skills.
  • Ability to manage multiple priorities and aggressive timelines

Competencies:

  • Commitment to ethical scientific investigations and rigorous experimental methods.
  • Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
  • Sense of urgency in performance of duties.
  • Interpersonal skills that promote a collaborative and productive lab environment.
  • Effective and efficient written and oral communication skills.

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.