Scientist, Analytical Development

About the role

The position reports to the Sr. QC Manager and is ideally suited for a professional with extensive technical knowledge and a proven track record of developing and carrying out processes suitable for use in GMP manufacturing of a wide range of clinical trial materials and participating in the technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

Responsibilities

• Apply knowledge of bio separation techniques to support method development, troubleshooting, and process characterization
• Support the establishment, development and optimization of Analytical Development (AD) and Quality Control (QC) laboratories to enable both Non-GMP and GMP testing
• Design, develop, and execute analytical methods, including method development, method qualification/validation, technology transfer, and product testing
• Own method lifecycle management activities, including authoring and reviewing protocols, reports, and technical documentation
• Support procedure lifecycle activities, including authoring and reviewing Standard Operating Procedures (SOPs) and associated forms. Perform and interpret a broad range of analytical assays, including but not limited to UPLC/HPLC, CE-SDS, and analytical ultracentrifugation (AUC)
• Drive continuous improvement initiatives across AD and QC, identifying opportunities to enhance assay robustness, efficiency, and data quality
• Analyze complex datasets and effectively communicate results, observations, and recommendations to internal and external stakeholders
• Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams to support product and process advancement
• Perform other duties as assigned based on business needs
• Up to 15% traveling to support CDMO projects or business development activities

Qualifications

• Master’s degree with 2+ years of relevant industry experience, or Bachelor’s degree with 5+ years, or Ph.D. with relevant experience
• Degree in Chemistry, Biochemistry, Molecular Biology, or related scientific field; experience in gene and cell therapy is a plus
• Hands-on experience with analytical techniques such as UPLC/HPLC, CE-SDS and/or AUC; experience working with MALS and/or CAD detectors is a plus
• Experience executing assays in accordance with Standard Operating Procedures and protocols in a regulated or controlled environment
• Strong problem-solving skills with the ability to work independently and collaboratively in a fast-paced environment
• Familiar with principles of Good Documentation Practices, Data Integrity, and ALCOA+
• Strong interpersonal, verbal, and written communication skills
• Experience with Next-Generation Sequencing (NGS) is a plus
• Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus

Pay and Benefits

Pay range is estimated between $80k - $110k based on skill set and experience.
Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.