Biological Scientist II

Manufacturing & Processing

• Execute cell processing procedures in accordance with approved SOPs, batch records, and GMP
  requirements
• Perform aseptic processing, cell culture, expansion, cryopreservation, thawing, and formulation
  activities.
• Prepare reagents, materials, and equipment required for manufacturing runs.
• Maintain clean-room standards, gowning compliance, and contamination control practices.

Documentation & Compliance

• Accurately complete batch records, logbooks, and GMP documentation contemporaneously.
  Participate in deviation reporting, CAPA support, and change control implementation. Maintain
  compliance with cGMP, institutional, and regulatory requirements.
• Participate in deviation reporting, CAPA support and change control implementation.
• Record and maintain detailed research procedures and results.
• Maintain compliance with cGMP, institutional, and regulatory requirements.
• Follow Good Documentation Practices (GDP) and maintain audit-ready records.

Training

• Participate in training activities for co-workers and junior staff.
• Perform scheduled tasks requiring strict adherence to SOPs with meticulous reporting and data
  entry.

Quality Control & Analytical Testing

• Perform analytical testing for cell therapy product release including flow cytometry, ELISA,
  endotoxin, Gram Stains and related assays.
• Assist with in-process monitoring and sample preparation.
• Analyze resulting data using statistical models to ensure product quality and process consistency.
• Document test results and ensure traceability in compliance with GMP requirements.

Salary commensurate with experience and education

• Prior experience in small- to intermediate-scale cell therapy manufacturing under GMP conditions strongly
  preferred.- Familiarity with autologous cell therapy manufacturing workflows is highly desirable.
• Experience with aseptic technique in ISO-classified cleanroom environments.
• Working knowledge of cGMP regulations and documentation practices.
• Understanding of Quality Control processes and basic analytical testing methods.
• Experience with flow cytometry, cell counting systems, or other cell-based analytical assays is a plus
  prior hands-on experience in clinical-stage cell therapy manufacturing under GMP conditions.
• A working understanding of quality control principles, and basic analytical testing skills to support
  in-process monitoring and product release activities.

SKILLS:

• Strong aseptic technique.
• High attention to detail and documentation accuracy.
• Ability to follow complex written procedures precisely.
• Understanding of chain-of-identity and chain-of-custody principles-Team-oriented with strong communication skills.
• Ability to work in a fast-paced clinical manufacturing environment.
• Proficient in Office Suite software.

PHYSICAL QUALIFICATIONS:

• Must be able to lift heavy boxes (approximately 50 lbs)
• Must be in good physical condition to clean the GMP facilities on a regular basis
  
  

Application must be submitted by 11:55 p.m. (ET) of the posting end date.