Position Overview:

We are seeking an energetic scientist with broad experience in the development of analytical methods for mRNA, gRNA, pDNA, and mAb platforms. The successful candidate will have deep understanding of analytical control strategy, CMC, product lifecycles, analytical regulatory guidances for mRNA, gRNA, pDNA, and/or mAb platforms. This position will primarily focus on analytical method development for one or more of the above molecule types. Some CMC and outsourcing management may also be involved. 

The ideal candidate will have experience in development and execution of analytical methods for mRNA, gRNA, pDNA, and mAb platforms under quality-by-design concepts, experience working collaboratively with cross-functional internal research and CMC teams (process development, regulatory, quality control, quality assurance), and management of external testing/manufacturing labs. This position will require a strong working knowledge of analytical ICH/USP guidelines.

Primary Responsibilities:

• Analytical representative to support Beam’s internal and external development on lead selection, optimization, production, and final DS/API/Critical component release and characterization.
• Work with cross-functional groups including process development and CMC team in various aspects of method development, assay and process transfer, characterization, comparability, and investigations.
• Reviewing and some authoring of development reports, qualification protocols, qualification reports, comparability protocols and reports, SOPs, COTs, and various regulatory filings.
• SME support for CMOs and CTOs as needed for method transfer, troubleshooting, etc.
• Training junior team members.

Qualifications:

• PhD, MS, BS in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related field.
• PhD (2-5 yrs), MS (3-8 yrs), BS (6-12 yrs) of experience in a pharmaceutical organization or a CRO.
• Ideal experience as an APL or assistant program lead.
• Analytical method development experience is a must focused on one or more of the following: mRNA, gRNA, pDNA, and mAbs.
• Excellent communication skills required for internal presentation and interactions with external collaborators.
• Creative problem solving and a team player with strong work ethic.
• Adaptability to a fast-paced environment.