Biological Scientist II-GMP Lab

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