Scientist II/Sr. Scientist I, Analytical Research and Development
Beam Therapeutics
2 months ago
On-site
Cambridge, MA
$130,000 - $180,000 USD yearly
Clinical Research and Development
Position Overview:
- Scientist II / Senior Scientist I with hands-on experience in analytical method development, optimization, qualification, and transfer to support release, stability, and characterization of cell and gene therapy products. Primarily supports in vivo lipid nanoparticle (LNP) programs; laboratory-based.
Primary Responsibilities:
- Lead early through late phase analytical method development, optimization, and transfer for lot release, stability, and characterization of drug substances, critical materials, and drug products.
- Serve as subject matter expert in multiple analytical techniques; provide technical troubleshooting support.
- Collaborate with Research & Development, Quality Control, and Process Development on method development, transfer, characterization, comparability, and investigations.
- Coordinate routine sample testing (including requests from R&D and Process Development teams).
- Author and review SOPs and technical reports; support preparation of CMC regulatory submissions.
- Analyze, track, and trend analytical assay data to ensure consistent assay performance.
- Maintain detailed experimental documentation in ELN systems.
- Adapt to a fast-paced, dynamic research environment.
- Mentor and train junior scientists.
Qualifications:
- Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related). Minimum PhD with 2+ years industry experience OR BS/MS with 10–15 years industry experience (title based on experience) in biotech/biopharma/CRO/CMO.
- Hands-on experience developing, optimizing, qualifying, and testing analytical methods in GMP or non-GMP settings supporting clinical phase programs.
- Experience analyzing RNAs, proteins, protein conjugates, lipids, and lipid nanoparticles (LNPs) (highly desirable).
- Extensive experience with one or more techniques: HPLC (RP, IPRP, SEC, IEX), capillary gel electrophoresis, ELISA (required). Plus: qPCR, DNA/RNA extraction, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, compendial testing.
- Experience with analytical CMC development, method transfer, and QC technical support (highly desirable).
- Working knowledge of analytical Quality by Design; understanding of ICH Q2 and Q14.
- CMC project management and people management experience (plus).
- Familiarity with Openlab, Chromeleon, and JMP (statistical software).
- Excellent oral and written communication; independently motivated, detail-oriented, strong critical thinking/problem-solving.
- Excellent organizational skills for multitasking in a fast-paced environment with changing priorities.
- Must be able to work onsite daily.
- Scientist II / Senior Scientist I with hands-on experience in analytical method development, optimization, qualification, and transfer to support release, stability, and characterization of cell and gene therapy products. Primarily supports in vivo lipid nanoparticle (LNP) programs; laboratory-based.
Primary Responsibilities:
- Lead early through late phase analytical method development, optimization, and transfer for lot release, stability, and characterization of drug substances, critical materials, and drug products.
- Serve as subject matter expert in multiple analytical techniques; provide technical troubleshooting support.
- Collaborate with Research & Development, Quality Control, and Process Development on method development, transfer, characterization, comparability, and investigations.
- Coordinate routine sample testing (including requests from R&D and Process Development teams).
- Author and review SOPs and technical reports; support preparation of CMC regulatory submissions.
- Analyze, track, and trend analytical assay data to ensure consistent assay performance.
- Maintain detailed experimental documentation in ELN systems.
- Adapt to a fast-paced, dynamic research environment.
- Mentor and train junior scientists.
Qualifications:
- Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related). Minimum PhD with 2+ years industry experience OR BS/MS with 10–15 years industry experience (title based on experience) in biotech/biopharma/CRO/CMO.
- Hands-on experience developing, optimizing, qualifying, and testing analytical methods in GMP or non-GMP settings supporting clinical phase programs.
- Experience analyzing RNAs, proteins, protein conjugates, lipids, and lipid nanoparticles (LNPs) (highly desirable).
- Extensive experience with one or more techniques: HPLC (RP, IPRP, SEC, IEX), capillary gel electrophoresis, ELISA (required). Plus: qPCR, DNA/RNA extraction, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, compendial testing.
- Experience with analytical CMC development, method transfer, and QC technical support (highly desirable).
- Working knowledge of analytical Quality by Design; understanding of ICH Q2 and Q14.
- CMC project management and people management experience (plus).
- Familiarity with Openlab, Chromeleon, and JMP (statistical software).
- Excellent oral and written communication; independently motivated, detail-oriented, strong critical thinking/problem-solving.
- Excellent organizational skills for multitasking in a fast-paced environment with changing priorities.
- Must be able to work onsite daily.