Position Overview:

Beam is seeking a highly talented and motivated VP of Pharmaceutical Sciences, to support our advancing portfolio of in-vivo and ex-vivo programs. Serving as a subject matter expert, this leader will be accountable for supporting all our cell-based potency assays. Their role will also drive our drug product development of our targeting moieties for our LNP platform and other macromolecules. They will support the lifecycle of the targeted drug product from IND submission through BLA approval. The candidate will define the strategic direction for our potency assays and key analytical methods, partnering closely with key stakeholders across the Pharmaceutical Sciences team. This is a high-impact leadership role requiring a data-driven, collaborative, results-oriented professional to ensure rapid progression of our key drug products through clinical development into commercial. This person will be responsible for comprehensive communication across all levels of the business, status reporting, risk management, escalation and resolution of issues.

Primary Responsibilities:

• Provides strategic, technical, and tactical leadership for all potency assays.
• Leads, mentors and develops the team responsible for the development of potency assays.
• Accountable for in vitro assay strategy to enable an IND through a BLA.
• Develop and implement strategic direction for analytical assays partnering with Analytical Development and Quality Control.
• Develop and implement strategic direction for drug product development for key binders and ligands including resolving manufacturing challenges.
• Work closely with CMC and cross-functional sub teams under the direction of the Program team(s).
• Develop and implement comprehensive product lifecycle strategies around assay development, manufacturing, and quality control in conjunction with Quality Assurance, Quality Control, Manufacturing, Process, and Analytical Development.
• Support lifecycle changes for potency assays.
• Work directly with regulatory and key stakeholders on the development and implementation of platform processes and analytics across the product lifecycle for in-vivo programs.
• Lead the preparation of source documentation and technical review of CMC sections for global regulatory submissions specifically focusing on Module 3.
• Act as the subject matter expert during regulatory meetings and support information requests from regulatory agencies.
• Actively identify risks across drug product areas during the product lifecycle. Oversee data-driven risk assessments and drive implementation of risk mitigations.
• Partner with Quality Assurance to ensure our potency assays comply with current Good Manufacturing Practices (cGMP), ICH guidelines, and phase-appropriate compliance standards.

Qualifications:

• MS, Ph.D., in Pharmaceutical Sciences, Biology, Biochemistry Chemistry, Chemical Engineering, Biomedical Engineering or equivalent technical field.
• 15+ years of experience in CMC development, including leadership experience.
• Strong experience and/or subject matter expertise in assay development, nucleic acid and/or Lipid Nanoparticle (LNP) manufacturing and analytics.
• Demonstrated experience advancing programs from preclinical through IND acceptance and preferably through Biological License Application (BLA) submission.
• Experience with cell based and analytical techniques such as HPLC, NGS, PCR, ELISA, MS, RNA quantitation, cell-based assays.
• External CDMO alliance management experience and oversight preferred.
• Strong background in participating in regulatory submissions and interactions.
• Strong knowledge of critical quality attributes and quality by design principles for nucleic acids and/or lipid nanoparticles.
• Strong cGMP manufacturing knowledge.
• High attention to detail with strong risk identification, management, and problem-solving skills.
• Able to effectively communicate upward (leadership) and outward (cross-functional teams) with strong presentation skills.