Director / Senior Director, Analytical Development
The Director / Senior Director of Analytical Development will lead and build the analytical strategy and infrastructure to support the development of JLSa2’s pipeline. This individual will be responsible for establishing and overseeing analytical development, qualification, and validation activities across peptide intermediates, drug substance (DS), and drug product (DP), while working closely with CDMOs and cross-functional teams. This role requires a hands-on leader with deep expertise in peptide/biologics analytical development, strong experience managing external partners, and the ability to operate effectively in a fast-paced biotech environment allowing you to have a major impact on our mission to support our patients.
Key Responsibilities
Analytical Strategy & Program Leadership
- Develop and execute the overall analytical development strategy for peptide intermediates, DS, and DP across all stages of development.
- Design and implement phase-appropriate analytical methods to support process development, characterization, release, and stability.
- Establish control strategies aligned with global regulatory expectations, including ICH guidelines (e.g., ICH Q2, Q5C, Q6B).
Peptide Intermediate Analytical Development
- Define and oversee analytical strategies for peptide intermediates, including in-process controls, impurity profiling, and release testing.
- Develop and qualify methods to monitor critical quality attributes (CQAs) such as sequence integrity, truncations, deletions, oxidation, deamidation, and aggregation.
- Support process development and manufacturing by providing analytical insight into intermediate quality and yield optimization.
- Ensure appropriate management of specifications and control strategies are established for intermediates to enable consistent DS quality.
Method Development, Qualification & Validation
- Oversee development, qualification, transfer, and validation of analytical methods (e.g., HPLC/UPLC, LC-MS, peptide mapping, amino acid analysis, potency assays).
- Ensure analytical methods are robust, stability-indicating, and suitable for regulatory submissions.
- Lead lifecycle management of analytical methods from early development through commercialization readiness.
Stability Program Management
- Design and oversee stability programs for peptide intermediates (as appropriate), DS, and DP, including protocol development and data trending.
- Ensure stability strategies support shelf-life assignments, hold-time studies, comparability, and regulatory filings.
- Interpret stability data to inform development decisions and control strategies.
CDMO & External Partner Management
- Serve as the primary analytical lead interfacing with CDMOs, CROs, and testing laboratories.
- Oversee method transfers, troubleshooting, and performance monitoring at external sites, including peptide synthesis vendors.
- Review and approve analytical data, protocols, reports, and technical documents generated by partners.
Deviation, OOS/OOT & Investigations
- Lead and support investigations related to OOS (Out of Specification), OOT (Out of Trend), and deviations across intermediates, DS, and DP.
- Ensure scientifically sound root cause analysis and implementation of corrective and preventive actions (CAPAs).
- Partner with Quality to ensure compliance with GMP standards.
Regulatory Support
- Author and review analytical sections of regulatory submissions (INDs, IMPDs, BLAs/MAAs), including justification of intermediate controls where applicable.
- Support interactions with regulatory agencies, including responses to information requests.
- Ensure all analytical activities align with current regulatory expectations and guidance.
Cross-Functional Collaboration
- Collaborate closely with Process Development, Manufacturing, Quality, Regulatory, and Clinical teams.
- Provide analytical expertise to support process characterization, comparability, and tech transfer activities, including scale-up of peptide synthesis.
- Contribute to overall CMC strategy and development planning.
Team Leadership (if applicable)
- Build, mentor, and lead internal analytical team as the organization grows.
- Establish best practices, systems, and infrastructure for analytical operations.
Qualifications
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 10+ years of experience; or
- M.S. with 12+ years; or B.S. with 15+ years of relevant experience.
- Significant experience in peptide and/or biologics therapeutics (GLP-1 or metabolic disease experience strongly preferred).
- Demonstrated progression in leadership roles (5+ years for Director / and 10+ years Sr. Director level).
Technical Expertise
- Deep knowledge of analytical techniques for peptides and biologics (e.g., HPLC/UPLC, LC-MS, peptide mapping, impurity profiling).
- Strong experience with intermediate control strategies and in-process testing for peptide synthesis.
- Proven experience with method development, validation, and lifecycle management in alignment with ICH Q2 and related guidelines.
- Proven experience designing and managing stability programs in accordance with ICH guidance.
- Strong understanding of GMP regulations and global regulatory frameworks.
Leadership & Operational Skills
- Extensive experience managing CDMOs, including peptide synthesis vendors and analytical testing labs.
- Strong track record in OOS/OOT investigations and root cause analysis.
- Ability to operate both strategically and tactically in a lean biotech environment.
- Excellent communication and cross-functional collaboration skills.
Preferred Qualifications
- Experience supporting programs from early development through Phase 2/3.
- Prior experience in metabolic disease or peptide therapeutics (e.g., GLP-1 analogs).
- Experience building or scaling analytical capabilities in a small biotech or virtual model.
- Prior experience with pre-approval inspection (PAI) readiness.
Salary Range: $190,000 to $260,000 (Compensation commensurate with experience/expertise/level and could fall outside of the stated range)
