Vice President, Pharmaceutical Sciences
Beam Therapeutics
August 10, 2026
Remote friendly (Cambridge, MA)
United States
$310,000 - $400,000 USD yearly
Clinical Research and Development
Primary Responsibilities:
- Provide strategic, technical, and tactical leadership for all potency assays.
- Lead, mentor, and develop the team responsible for potency assay development.
- Own in vitro assay strategy to enable an IND through BLA.
- Develop and implement strategic direction for analytical assays in partnership with Analytical Development and Quality Control.
- Develop and implement strategic direction for drug product development for key binders/ligands (resolving manufacturing challenges).
- Partner with CMC and cross-functional sub-teams under Program team direction.
- Develop and implement product lifecycle strategies covering assay development, manufacturing, and quality control with QA, QC, Manufacturing, Process, and Analytical Development.
- Support lifecycle changes for potency assays.
- Work with regulatory stakeholders on platform process/analytics across the product lifecycle for in-vivo programs.
- Prepare source documentation and perform technical review of CMC sections for global regulatory submissions (Module 3).
- Serve as subject matter expert during regulatory meetings and respond to regulatory information requests.
- Identify and assess risks across drug product areas; drive risk mitigations.
- Partner with Quality Assurance to ensure potency assays comply with cGMP, ICH guidelines, and phase-appropriate standards.
Qualifications:
- MS or PhD in Pharmaceutical Sciences, Biology, Biochemistry/Chemistry, Chemical Engineering, Biomedical Engineering, or equivalent.
- 15+ years of CMC development experience, including leadership.
- Strong assay development expertise; nucleic acid and/or LNP manufacturing and analytics.
- Experience advancing programs from preclinical through IND acceptance, preferably to BLA.
- Cell-based and analytical techniques (e.g., HPLC, NGS, PCR, ELISA, MS, RNA quantitation, cell-based assays).
- External CDMO alliance management experience preferred.
- Background in regulatory submissions and interactions.
- Knowledge of critical quality attributes and quality by design for nucleic acids and/or lipid nanoparticles.
- Strong cGMP manufacturing knowledge.
- Strong risk identification/management and problem-solving skills.
- Ability to communicate effectively upward and outward; strong presentation skills.
- Provide strategic, technical, and tactical leadership for all potency assays.
- Lead, mentor, and develop the team responsible for potency assay development.
- Own in vitro assay strategy to enable an IND through BLA.
- Develop and implement strategic direction for analytical assays in partnership with Analytical Development and Quality Control.
- Develop and implement strategic direction for drug product development for key binders/ligands (resolving manufacturing challenges).
- Partner with CMC and cross-functional sub-teams under Program team direction.
- Develop and implement product lifecycle strategies covering assay development, manufacturing, and quality control with QA, QC, Manufacturing, Process, and Analytical Development.
- Support lifecycle changes for potency assays.
- Work with regulatory stakeholders on platform process/analytics across the product lifecycle for in-vivo programs.
- Prepare source documentation and perform technical review of CMC sections for global regulatory submissions (Module 3).
- Serve as subject matter expert during regulatory meetings and respond to regulatory information requests.
- Identify and assess risks across drug product areas; drive risk mitigations.
- Partner with Quality Assurance to ensure potency assays comply with cGMP, ICH guidelines, and phase-appropriate standards.
Qualifications:
- MS or PhD in Pharmaceutical Sciences, Biology, Biochemistry/Chemistry, Chemical Engineering, Biomedical Engineering, or equivalent.
- 15+ years of CMC development experience, including leadership.
- Strong assay development expertise; nucleic acid and/or LNP manufacturing and analytics.
- Experience advancing programs from preclinical through IND acceptance, preferably to BLA.
- Cell-based and analytical techniques (e.g., HPLC, NGS, PCR, ELISA, MS, RNA quantitation, cell-based assays).
- External CDMO alliance management experience preferred.
- Background in regulatory submissions and interactions.
- Knowledge of critical quality attributes and quality by design for nucleic acids and/or lipid nanoparticles.
- Strong cGMP manufacturing knowledge.
- Strong risk identification/management and problem-solving skills.
- Ability to communicate effectively upward and outward; strong presentation skills.