Classification Title:
Biological Scientist II
Classification Minimum Requirements: Bachelor''''s degree in biology or a related field and three years of experience or Master''''s degree in biology or a related field with one year of relevant experience. Job Description: 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 cleanroom 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.
Expected Salary:
$61,350-$69,700
Required Qualifications: Bachelor''''s degree in biology or a related field and three years of experience or Master''''s degree in biology or a related field with one year of relevant experience. Preferred:
- 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
Special Instructions to Applicants:
For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes