Beam Therapeutics

Director/Senior Director, CMC Operations

Cambridge, MA · Director · Full-time

Sponsorship not specified$210k-$320kDetected 6 days ago

C++Product ManagementGMPPCRCRISPRNGSMass SpectrometryProtein AnalysisAnimal StudiesLeadershipCommunicationProblem Solving

About the role

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 with integrated gene editing, delivery and internal manufacturing capabilities.
This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.

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.
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.
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.

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.
Experience with analytical techniques such as HPLC, NGS, PCR, ELISA, MS, RNA quantitation, cell-based assays.
BS/MS, Ph.D., in Biology, Chemistry, Chemical Engineering, Biomedical Engineering or equivalent technical field.
Demonstrated experience advancing programs from preclinical through IND acceptance and preferably through Biological License Application (BLA) submission.
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.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Beam Pay Range
$210,000 - $320,000 USD

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.

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.

This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.