Scientist II - Bioprocess Development
Logistics
Inventory Management
Procurement
Laboratory
Antibodies
Cell Biology
Microbiology
Virology
Analytical Testing
Analytical Instrumentation
Experimental Design
Description:
Purpose of the Role
This position supports the development of biological products, including vaccines, proteins, antibodies, and other therapeutic candidates, from research and development through transition into manufacturing operations. The role requires knowledge of upstream and/or downstream bioprocessing, formulation, and in-process analytical methodologies and is expected to operate with minimal supervision. Key responsibilities include:
- Provide support for in-process analytical testing activities for biological and therapeutic processes.
- Support process development, optimization, and scale-up of biological and therapeutic products.
- Support experimental formulation development and testing activities for therapeutic and vaccine production.
- Generate timely and actionable analytical data to improve process understanding.
- Support data-driven decision-making during development and manufacturing transition activities.
- Contribute to successful advancement of biological products from development into manufacturing operations.
Duties and Responsibilities
- Conduct experiments related to raw material selection, process optimization, robustness evaluation, and process confirmation.
- Assist in executing high-throughput experimental design studies for bioprocess and formulation teams.
- Develop proficiency with analytical instrumentation such as HPLC systems, nutrient and metabolite analyzers, and cell counters.
- Perform buffer preparation
- Accurately analyze data and results and interpret experimental outcomes under supervision.
- Follow protocols, conduct studies, and provide data compilation to generate reports.
- Maintain accurate, complete, and ethical documentation practices.
- Set up, operate, and maintain bioprocess and in-process analytical instrumentation.
- Support qualification of new equipment and ensure operational readiness.
- Support day-to-day laboratory operations through effective organization, logistics coordination, procurement and receipt of laboratory supplies and materials, inventory management, and accurate tracking, storage, and management of samples.
Compliance Responsibilities
- Ensure adherence to regulatory, GMP, and EHS requirements.
- Comply with applicable regulations, perform all work in a safe manner, and maintain proper records in accordance with Standard Operating Procedures (SOPs) and policies.
- Ensure compliance with Good Documentation Practices (GDP) by confirming that all data are accurately recorded and that documentation and files are reviewed, secured, and approved as required.
- Operate within a regulated environment and maintain a basic understanding of GxP-regulated activities and compliance expectations.
Skills
- Ability to work cross-functionally and effectively within a team environment.
- Demonstrated willingness to advance knowledge of bioprocess and in-process analytical development.
- Ability to apply basic scientific theory and principles.
- Ability to learn new technologies and concepts and apply them appropriately with minimal supervision.
- Ability to report technical data and information accurately and concisely.
- Ability to troubleshoot technical and operational issues.
- Strong written and verbal communication skills.
- Appropriate understanding of applicable regulatory expectations.
Education
- Bachelor's degree in chemical or biological engineering, or a related scientific field from an accredited institution, with a minimum of two (2) years of experience in a related scientific discipline preferred.
- Background in microbiology, cell biology, and/or virology.
- General knowledge of bioprocessing, including bioreactor operation, downstream processing, and in-process analytical techniques.
QUALIFICATION/ LICENSURE :
- Work Authorization : Green Card, US Citizen
- Travel Required : No travel required
- Shift timings: Not specified