Associate Director, Analytical Development & QC Lab

PepGen, Inc.; Boston (MA); On-site; USD 170,000 - 220,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision Insurance

401(k) plan

Paid time off

Parental leave

Cell phone reimbursement

Equity

Lifestyle spending account

Job summary

PepGen, Inc. seeks an Associate Director of Analytical Development to lead the internal lab and support PD/CMC efforts.

You will guide method development for peptides, oligos, and conjugates using UHPLC-UV and LC-MS, and coordinate with discovery and CMO partners to ensure robust analytics for regulatory submissions. The role demands leadership of a cross-functional team, strategic planning, and strong knowledge of cGMPs, IND/IMPD processes, and regulatory science to advance PepGen’s

Qualifications

• Ph.D. in Chemistry or related field with 5+ years leading analytical development teams, or a Masters with 8+ years in similar roles.
• Experience with peptides, oligonucleotides, or peptide-oligo conjugates.
• Proven track record in CQA assessment and NDA-enabling characterization.
• Experience leading method development, transfer, and regulatory filing sections.

Responsibilities

• Manage the internal analytical development lab and implement new technologies.
• Lead analytical method development for purity/impurity analysis of small molecules and biomolecules.
• Provide analytical support to discovery and development activities, including COT issuance.
• Oversee maintenance of analytical equipment and instrument performance.
• Lead method development and validation, including external lab collaboration (CTLs/CMOs).
• Review protocols and reports from external labs; review release and stability data.
• Write protocols and source documents for regulatory filings; lead characterization activities.
• Mentor and manage the AD/QC team and coordinate cross-functional work.

Skills

leadership

project management

analytical development

cross-functional collaboration

communication

Education

Ph.D. in Chemistry or related area

Masters degree

Tools

UHPLC-TOF

UHPLC-MS/MS

HPLC

LC-MS

GC

Job description

PepGen, Inc. seeks an Associate Director of Analytical Development to lead the internal lab and support PD/CMC efforts.

You will guide method development for peptides, oligos, and conjugates using UHPLC-UV and LC-MS, and coordinate with discovery and CMO partners to ensure robust analytics for regulatory submissions. The role demands leadership of a cross-functional team, strategic planning, and strong knowledge of cGMPs, IND/IMPD processes, and regulatory science to advance PepGen’s