Associate Director/Director of Vector Process Development and MS&T
PRIMARY OBJECTIVE: The candidate will bring to the role a strong understanding and demonstrated expertise with the latest vector bioprocessing technologies, process development/qualification/validation, and technical transfers. His/her functions will include but are not limited to: process definition, GMP adaptation, and process characterization of clinical vector manufacturing processes; technology transfer to CMOs; process ownership and management of process technical documents; and resolution of process-related technical issues in development and manufacturing. The successful candidate will be responsible for working across functional areas such as research, development, clinical, regulatory, and manufacturing to enable critical decisions across the Arcellx portfolio.
ABOUT ARCELLX: 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 is located in Gaithersburg, Maryland and has assembled 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.
The main responsibilities will include but are not limited to:
- Provide management and accountability for the development of GMP processes to enable clinical cell manufacturing.
- Manage and develop the vector process development team with a focus on scientific excellence and quality of technical decision making.
- Lead team in producing empirical data to enable process improvements, and to characterize the process, define process parameter criticality, and develop the process control strategy.
- Provide senior scientific leadership and set strategic direction of technology advancement.
- Conduct Technical Transfers to CMOs and provide manufacturing science and technology support to ensure robust production in GMP environment.
- Review and finalize batch records, SOPs, raw material specifications, development reports and GMP protocols at Arcellx and CMOs.
- Oversee the change management of different process versions and comparability assessments for process changes.
- Contribute to relevant CMC sections of IND/BLA and other regulatory documents.
- Collaborate with analytical, cell process development, and protein science teams to identify relevant assays for cell quality attributes.
- PhD in Chemical Eng, Biological Engineering, Chemistry, or Biological Science with 8 or more years of relevant experience and demonstrated technical leadership in process development, or MS/BS with 12+ years of relevant experience.
- Experience working in a GMP regulated environment.
- Strong scientific and operational background in implementation of vector bioprocessing unit operations and manufacturing.
- Strong understanding of process development, technical transfer, and GMP requirements.
- Experience with IND and/or BLA submissions.
- Experience managing individual contributors.
- Detail oriented, exceptional documentation practices, technical writing and verbal communication skills.
- Demonstrated effective interpersonal, communication and negotiation skills for a wide variety of audiences, including senior leaders.
- Courage to lead and make tough decisions/strong influencing skills.
- Maintaining a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.
- Excellent contingency planning and time management skills and demonstrated ability to manage several projects simultaneously.
- Possess strong 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.
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