Careers

Scientist or Senior Scientist-Protein Sciences

Posted 3 weeks ago

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 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.

Position Profile:

We are seeking a Scientist or Senior Scientist to join the Protein Sciences Department (Purification Process Development team) in Gaithersburg, Maryland to support CMC development of therapeutic proteins. Under the direction of the Director of Purification Process Development, the scientist is responsible for the development, optimization, characterization, scale-up, technical transfer and validation of GMP-compliant manufacturing processes for protein targets. This position requires broad scientific understanding and hands-on execution of a variety of downstream unit operations, with a focus on chromatography, depth and membrane filtration, and TFF. The successful candidate is expected to work independently on assigned tasks/projects and communicate results to their supervisor and management.

Key Responsibilities:

  • Experimental design, planning, organization, execution and analysis.
  • Executing a variety of downstream unit operations, including but not limited to:
  • Harvest/clarification by filtration: normal flow (NF) filtration using depth and membrane filter units, tangential flow filtration (TFF) using flat sheet cassettes and hollow fiber cartridges
  • Chromatography (ion exchange, hydrophobic interaction, mixed mode, affinity, etc.)
  • Process scale-up and technical transfer of bench scale processes into GMP Manufacturing facility
  • Active participation in daily maintenance of laboratory equipment
  • Record keeping in laboratory notebooks; versatile knowledge of MS Excel for data analysis and MS Word / PowerPoint / Visio for and authoring of procedures, protocols, technical reports and presentations.
  • Some travel expected to support technical transfer to an external GMP facility

Required Qualifications:

  • S., M.S. or Ph.D. in biochemistry, chemistry, chemical engineering or biological sciences
  • Minimum 8+ years (for B.S.), 5+ years (for M.S.) or 3+ years (for Ph.D.) in downstream process development
  • Scientific understanding of and hands-on experience with a variety of downstream unit operations, including but not limited to:
  • Harvest/clarification by filtration: normal flow (NF) filtration using depth and membrane filter units, tangential flow filtration (TFF) using flat sheet cassettes and hollow fiber cartridges
  • Chromatography (ion exchange, hydrophobic interaction, mixed mode, affinity, etc.) using AKTA
  • Knowledge of Manufacturing scale equipment and understanding the principles of scale-up and technical transfer of bench scale processes into GMP Manufacturing facility
  • Versatile knowledge of MS Excel for data analysis, MS Word / PowerPoint / Visio for authoring of procedures, protocols, technical reports and presentations. Strong verbal and written communication
  • Ability to travel to support technical transfer activities

Preferred Qualifications:

  • Microbial cell lysis/ inclusion body processing, refolding techniques
  • Centrifugation: continuous flow, lab batch, ultra
  • Scientific understanding and hands-on experience with various supporting analytical techniques, such as HPLC, spectrophotometry, SDS-PAGE, BCA, etc.
  • Process characterization, familiarity with QbD principles, use of DOEs
  • Equipment qualification, maintenance and calibration
  • Familiarity with viral clearance studies
  • Exposure to Change controls, CAPAs, deviation investigations
  • Exposure to regulatory submissions (e.g. IND, BLA) CMC sections
  • External publications and presentations

Competencies:

  • 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: hr@nullarcellx.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.

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