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About the Role

Lead and build the analytical strategy and infrastructure to support the development of JLSa2’s pipeline. Establish and oversee 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.

Responsibilities

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.
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.
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.
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.
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.
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.
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.
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.
Build, mentor, and lead internal analytical team as the organization grows.
Establish best practices, systems, and infrastructure for analytical operations.

Requirements

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).
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.
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.
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.

Skills

Analytical Development
Method Development
Method Qualification
Method Validation
HPLC/UPLC
LC-MS
Peptide Mapping
Amino Acid Analysis
Potency Assays
Impurity Profiling
Stability Programs
ICH Guidelines
GMP Regulations
OOS/OOT Investigations
Root Cause Analysis
CDMO Management
Regulatory Submissions
CMC Strategy

Location

Remote

Work Type

Full-time

Experience Level

Director
Senior Director

Education Level

Ph.D.
M.S.
B.S.

Salary/Compensations

$190,000 to $260,000

About the Company

JLSa2 is a biotech company focused on supporting patients through its pipeline development.