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