Associate Director, Analytical Research & Development

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

Beam is looking for a highly energetic and highly talented Associate Director/Director to join our growing Analytical Research and Development team.  The incumbent will be primarily responsible for supporting the process and formulation teams developing and optimizing manufacturing processes for plasmids, oligonucleotides (gRNA and mRNA), and lipid nanoparticles (LNP). The incumbent will also have extensive experience in developing and validating in-process analytical assays. This individual will work closely with process and formulation scientists to optimize and troubleshoot process/formulation related issues as needed. Extensive knowledge and/or background in IP-RPLC, CE, SEC immunological, PCR, UV for late-stage applications is necessary. The lead candidate should also have demonstrated leadership in a similar role at a Biotechnology or large Pharma company. The ideal candidate should have deep understanding of ICH guidelines, Quality by Design (QbD), and Critical Quality Attributes (CQA) assessment. Extensive understanding of cGMP regulations and developing risk-based analytical control strategies around Cell and Gene therapy products is necessary.

Responsibilities:

• Oversee a team dedicated to providing routine in-process testing support including application of automation.
• Develop and qualify key assays that maybe suitable for improved process and formulation understanding
• Provide technical oversight and guidance to process, formulation, and analytical teams
• Collaborate with Analytical, CMC, and Functional leads to prioritize the work to ensure process/formulations teams receive the right level of support on a timely basis
• Capable of applying elements of QbD and ICH Q14 to assist with developing an enhanced process and analytical control strategy  
• Analyze, interpret, and present data to internal and external audience using various formats
• A thought leader in Analytical Research and Development

Qualifications:

• PhD degree with 12 + years’ experience or MS degree with 15+ years analytical development experience in a Pharmaceutical or CDMO organization
• Previous experience with assay qualifications and validation is necessary
• Good understanding of cGMP manufacturing guidelines
• Prior experience with tech transfer of assays
• Knowledge of key analytical testing of mRNA and LNPs
• Proven Leadership
• Effective communication skills
• Strong work ethic
• Clear and effective written and verbal communication skills, with excellent technical and scientific writing skills
• Able to deliver across multiple projects, prioritize demands, and thrive under tight timelines
• Strong interpersonal skills, ability to influence, and ability to work in a fast-paced and collaborative environment
• This position is an onsite role, but some level of virtual off-site work is feasible