Director, Analytical Development, CMC

Neomorph•San Diego, CA

6h•Onsite

About The Position

We are seeking an experienced and highly motivated Director, Analytical Development, CMC to lead analytical development and quality control strategy across our small-molecule degrader portfolio. The Director, Analytical Development, CMC, will serve as the analytical development subject-matter expert and functional lead for our pre-clinical and clinical programs. This individual will be responsible for analytical strategy, method development, qualification, validation, specifications, release testing, stability, reference standards, impurity control, and regulatory CMC documentation for drug substance and drug product candidates. The successful candidate will work closely with internal CMC, discovery chemistry, quality assurance, regulatory, clinical supply, and program leadership teams, as well as external CDMOs, CROs, and contract testing laboratories. This role is well suited for a hands-on strategic leader who can operate effectively in a lean, platform-driven biotech environment and manage outsourced analytical development activities with strong technical judgment.

Requirements

PhD, MS, or BS in analytical chemistry, organic chemistry, pharmaceutical sciences, chemistry, or a related scientific discipline.
10+ years of relevant industry experience with a PhD, 12+ years with an MS, or 15+ years with a BS in small-molecule analytical development, QC, or CMC technical operations.
Demonstrated experience supporting small-molecule drug substance and drug product development.
Strong technical knowledge of HPLC/UPLC, GC, LC-MS, GC-MS, dissolution, KF, ICP-MS, NMR, XRPD, DSC/TGA, particle size, residual solvents, genotoxic impurities, nitrosamines, forced degradation, and stability-indicating methods.
Experience with method development, qualification, validation, transfer, release testing, and stability testing in a GMP environment.
Strong understanding of ICH guidance and global regulatory expectations for small-molecule CMC development, including method validation, impurities, specifications, stability, starting material justification, and CTD Module 3 documentation.
Experience managing CDMOs, CROs, and contract analytical laboratories in an outsourced or virtual biotech model.
Track record of contributing to IND, IMPD, NDA, MAA, or other regulatory submissions.
Ability to critically review analytical data, identify technical risks, troubleshoot investigations, and drive practical solutions.
Excellent written and verbal communication skills, with the ability to influence cross-functional teams and external partners.

Responsibilities

Lead analytical development strategy for small-molecule molecular glue degrader drug substance and drug product programs from preclinical development through clinical manufacturing and later-stage readiness.
Develop, qualify, validate, transfer, and troubleshoot phase-appropriate analytical methods for raw materials, starting materials, intermediates, in-process controls, drug substance, drug product, impurities, degradants, residual solvents, dissolution, assay, content uniformity, polymorphs, particle size, and related quality attributes.
Establish analytical control strategies and specifications for starting materials, intermediates, drug substance, and drug product, including justification of acceptance criteria appropriate to the program stage and molecular glue degrader modality.
Partner with process chemistry and medicinal chemistry teams to understand compound-specific analytical challenges, including physicochemical properties, degradation pathways, impurity profiles, stereochemical considerations, salt and solid-form selection, and stability risks.
Oversee analytical development, QC testing, method transfer, GMP release testing, and stability studies performed by CDMOs, CROs, and contract analytical laboratories.
Review and approve analytical protocols, methods, validation reports, release and stability data, certificates of analysis, technical reports, deviations, OOS/OOT investigations, CAPAs, and change controls.
Partner with process chemistry and drug product teams to support route development, process optimization, formulation development, impurity identification, forced degradation studies, comparability assessments, and overall CMC control strategy development.
Design and manage stability programs, including forced degradation, photostability, accelerated and long-term stability, shelf-life assignment, clinical retest period, and expiry strategy for clinical materials.
Support reference standard strategy, impurity standards, metabolite standards where applicable, qualification, characterization, inventory, and lifecycle management.
Author and review analytical and quality-related sections of regulatory submissions, including INDs, IMPDs, briefing packages, annual reports, amendments, CTD Module 3 sections, and responses to health authority questions.
Ensure analytical activities are conducted in compliance with applicable cGMP, ICH, FDA, EMA, and global regulatory expectations for small-molecule development.
Represent analytical development on cross-functional CMC, program, and targeted protein degradation platform teams, communicate risks and recommendations clearly, and drive timely execution of CMC deliverables.
Monitor emerging regulatory and technical expectations relevant to small-molecule targeted protein degradation programs, including impurity control, nitrosamine risk assessment, genotoxic impurity assessment, elemental impurities, residual solvents, and stability-indicating method strategy.
Build scalable analytical development practices, documentation standards, vendor oversight processes, and quality systems appropriate for a growing molecular glue degrader biotech organization.

Benefits

Industry-competitive compensation
Annual target bonus
Stock options
401K plan
Career advancement opportunities
Monthly town halls to share business and scientific updates
Comprehensive medical, dental, and vision plans for employees and their dependents
Health and Dependent Care FSA and HSA Plan with monthly Neomorph contribution
Employee Assistance Program
10 holidays + Winter Shutdown + 3 weeks of vacation time with additional accruals after 2nd year of employment, separate sick leave.
Supplemental pay for Pregnancy Disability Leave
Paid Parental Leave for employees with a newborn child or a child placed with them for adoption or foster care
Volunteer days off each year to spend time contributing to causes you care about
Flexible work schedule
Access to onsite gym
Onsite space to store your bicycle (or surfboard)