Associate Scientist I - Analytical Development

Job Description

The Associate Scientist will execute in-process analytical testing, assay development, and GMP testing when needed for gene therapy products, collaborating with a multidisciplinary Process Development Team, GMP testing team, Quality Assurance, and Manufacturing team.

Primary Responsibilities:

• Execute testing in the development laboratory.
• Collaborate with a diverse team to execute assays for gene therapy applications.
• Conduct cell-based, molecular, and analytical assays.
• Design, execute, and interpret experiments under supervision to meet objectives.
• Write test methods in accordance with company objectives for SOPs and GMP test methods.
• Conduct development, verification, and qualification studies on various test methods as well as routine sample testing.
• Develop presentations and communicate technical results to internal technical groups.
• Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices and SOPs.
• Generate, analyze, and record high-quality data using documentation and database tools.
• Contribute to laboratory organization, maintenance, and stocking of pertinent assay materials.
• Independently execute analytical methods to characterize viral vector products.
• Perform analytical testing in support of process development, cGMP investigations, and product characterization.
• Characterize process- and product-related impurities in cell products and viral vectors in collaboration with process development teams.

Education, Experience, & Qualification:

• Bachelor’s or Master’s degree in Biology, Biochemistry, Molecular Biology, Immunology, or related discipline.
• 0–4 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or related field with relevant lab experience in pharma/biotech.
• Experience with in-process analytics and characterization methods including plate-based assays, immunoassays/ELISAs, PCR-based assays (qPCR, ddPCR, dPCR), or other common analytics is strongly preferred.
• Experience in mammalian cell culture, cell-based assays, and aseptic techniques strongly preferred.
• Strong problem-solving skills and a data-driven approach to decision-making.
• Ability to thrive in a fast-paced, goal-oriented, multifaceted team environment with independence, self-motivation, and innovative thinking.
• Commitment to maintaining a safe and compliant laboratory environment.

Key Competencies:

• Excellent time management skills with proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Demonstrated ability to conduct experiments to meet technical objectives.
• Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively, both written and verbal.
• Ability to collaborate with team members to complete projects efficiently.
• Ability to function well in a high-paced, and at times stressful, environment.
• Prior lab experience is desirable.

Physical Requirements:

• Prolonged periods of standing or sitting while working in the laboratory.
• Must be able to lift up to 15 pounds at times.