Director/Senior Director, CMC Operations

Position Overview:

Beam is seeking a highly talented and motivated Sr. Director / Director of CMC, to lead our advancing portfolio of in-vivo and ex-vivo programs. Serving as a subject matter expert, this leader will be accountable for all CMC deliverables spanning the lifecycle of the product from IND submission through BLA approval. The candidate will define the strategic direction for both manufacturing processes and analytical methods, partnering closely with key stakeholders across the business. This is a high-impact leadership role requiring a data-driven, collaborative, results-oriented professional to ensure the integrated control strategy is appropriate for the product as the program moves 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 a portfolio of in-vivo CMC programs.
• Accountable for all CMC program deliverables to enable an IND through a BLA.
• Develop and implement strategic direction for analytical methods partnering with Analytical Development and Quality Control.
• Develop and implement strategic directions for manufacturing processes partnering with process development, MS&T, and manufacturing.
• Lead the CMC sub-team(s) and cross-functional sub teams under the direction of the Program team(s).
• Develop and implement comprehensive product lifecycle strategies around process / analytical development, manufacturing, and quality control in conjunction with Quality Assurance, Quality Control, Manufacturing, Process, and Analytical Development.
• Develop comparability strategies and author protocols to support product lifecycle changes for process changes, analytical changes, and secondary suppliers.
• Work directly with regulatory and key stakeholders on the development and implementation of platform processes and analytics across the CMC 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 CMC subject matter expert during regulatory meetings and support information requests from regulatory agencies.
• Serve as a subject matter expert for process and analytical challenges while being accountable for driving to a resolution.
• Drive accountability for cross functional partners to meet CMC program timelines and deliverables such as drug supply planning to meet clinical and commercial needs.
• Actively identify risks across all CMC areas during the product lifecycle. Oversee data-driven risk assessments and drive implementation of risk mitigations.
• Actively participate in the strategic design and execution of Extractables and Leachables (E&L) studies and clinical in-use studies.
• Partner with Quality Assurance to ensure all CMC activities comply with current Good Manufacturing Practices (cGMP), ICH guidelines, and phase-appropriate compliance standards.
• Collaborate closely with process development on the optimization and scale up of the manufacturing process to support program needs from clinical through commercial as well as actively participate in CQA identification, CPP, and KPP classification.

Qualifications:

• BS/MS, Ph.D., in Biology, Chemistry, Chemical Engineering, Biomedical Engineering or equivalent technical field.
• 10+ years of experience in CMC development, including leadership experience.
• Strong experience and/or subject matter expertise in 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 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.