Director Analytical Development

Position Summary:

The Director, Analytical Development will provide technical and strategic leadership for analytical development, characterization, method lifecycle management, and testing strategies supporting the Company's biologics programs, with primary responsibility for supporting late-stage clinical development and advancing programs toward commercial readiness. This individual will serve as the Company's analytical development subject matter expert and primary technical representative with external laboratories, Contract Development and Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs), supporting all phases of clinical development with a focus on Phase 3 clinical supply, process characterization and validation, comparability, specifications, stability, method qualification/validation and transfer, regulatory submissions, PPQ, and preparation for commercial manufacturing.

The Director will partner closely with Upstream and Downstream Manufacturing, Quality, Regulatory Affairs, Supply Chain, Program Management, and external analytical and QC partners to ensure analytical methods and control strategies are scientifically sound, phase-appropriate, compliant, robust, and suitable for commercialization. The role requires strong scientific judgment, ownership, and the ability to influence and drive results in a lean, highly outsourced operating model.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Late-Stage Analytical Development and Commercial Readiness

• Provide technical and strategic leadership for analytical development activities supporting all phases of clinical development and progression toward commercial manufacturing.
• Develop and execute analytical strategies generating and implementing new specifications, supporting clinical supply, process characterization, PPQ/process validation, regulatory submissions, and commercial launch.
• Lead development and implementation of phase-appropriate analytical control strategies for biologic drug substance and drug product.
• Drive analytical method development, optimization, qualification, validation, transfer, and lifecycle management.
• Ensure analytical methods are appropriate for their intended use and capable of supporting product release, stability, characterization, comparability, and process validation activities.
• Partner with Quality and Regulatory CMC to establish and justify appropriate specifications for drug substance, drug product, intermediates, and other relevant materials.
• Provide analytical leadership supporting PPQ and commercial readiness activities.

Analytical Characterization and Product Understanding

• Lead analytical characterization strategies to establish and maintain comprehensive understanding of product quality attributes.
• Develop and oversee analytical approaches for evaluating identity, purity, contamination, potency, strength, charge variants, size variants/aggregates, glycosylation, post-translational modifications, and process- and product-related impurities, as applicable.
• Partner with Process Development and Manufacturing to establish relationships between process parameters and critical quality attributes (CQAs).
• Lead analytical strategies supporting comparability assessments associated with manufacturing process, scale, site, formulation, raw material, or other changes.
• Ensure appropriate use of orthogonal analytical methods to characterize product structure, function, purity, and biological activity.
• Evaluate analytical data and product quality trends to identify potential risks or changes in product performance.

External Laboratory, CRO, and CDMO Leadership

• Serve as the Company's analytical technical lead and subject matter expert with external testing laboratories, CROs, and CDMOs.
• Lead technical evaluation, selection, qualification, governance, and ongoing performance management of analytical partners.
• Oversee outsourced analytical development, method validation, method transfer, characterization, Quality control release, and stability testing activities.
• Review analytical protocols, methods, specifications, validation plans and reports, stability protocols, investigations, and technical reports.
• Establish strong technical relationships with external analytical development, QC, manufacturing, quality, and project management teams; appropriately challenge and escalate analytical, quality, timeline, or execution risks.
• Provide technical input to scopes of work, agreements, change orders, and vendor discussions related to analytical requirements and capabilities.

Analytical Method Development, Validation, Transfer, and Lifecycle Management

• Lead development, optimization, qualification, and validation of analytical methods supporting biologic drug substance and drug product.
• Establish analytical method validation strategies consistent with applicable ICH, FDA, EMA, and compendial expectations.
• Lead analytical method transfers between development laboratories, CROs, CDMOs, QC laboratories, and commercial testing sites.
• Ensure effective transfer of analytical knowledge, methods, acceptance criteria, reference standards, system suitability requirements, and technical procedures.
• Monitor method performance following transfer and validation and identify opportunities for appropriate method improvements.
• Develop and maintain analytical method lifecycle strategies supporting late-stage development through commercialization.

Stability and Specification Strategy

• Provide technical leadership for stability strategies supporting clinical development, regulatory submissions, and commercialization.
• Partner with Quality and Regulatory CMC to develop scientifically justified specifications and acceptance criteria.
• Review and interpret stability data, generate trends, support excursions, and out-of-specification or out-of-trend results.
• Support establishment and justification of shelf life, storage conditions, and relevant stability commitments.
• Ensure stability programs appropriately support regulatory filing and commercial requirements.

Analytical Troubleshooting and Investigations

• Provide technical leadership for analytical investigations, including OOS, OOT, atypical results, method performance issues, and laboratory deviations.
• Lead or support root-cause investigations and development of scientifically sound corrective and preventive actions.
• Evaluate analytical trends and method performance to proactively identify potential risks.
• Partner with Quality, Manufacturing, and external laboratories to ensure timely investigation and resolution of analytical issues that could impact clinical supply or program timelines.
• Assess analytical changes for potential comparability, validation, product quality, and regulatory impact.

Quality and Regulatory Leadership

• Ensure analytical development activities comply with applicable cGMP, ICH, FDA, EMA, pharmacopeial, and internal quality requirements.
• Provide technical review and approval, as appropriate, of analytical methods, validation protocols and reports, specifications, stability protocols, investigations, change controls, CAPAs, risk assessments, and technical reports.
• Serve as the analytical development SME for regulatory submissions and health authority interactions.
• Lead or contribute to preparation and review of relevant IND/IMPD/BLA/MAA CMC analytical sections, including analytical procedures, method validation, specifications, characterization, stability, and comparability content.
• Support responses to health authority questions related to analytical methods, specifications, stability, product characterization, and control strategy.
• Support regulatory inspections, partner audits, and pre-approval inspection readiness for analytical activities.

Cross-Functional CMC Leadership and Risk Management

• Partner closely with Upstream and Downstream Manufacturing to ensure analytical strategies appropriately support process development, process characterization, technology transfer, manufacturing investigations, and PPQ.
• Collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Process Development, Supply Chain, and CMC leadership to advance program objectives.
• Proactively identify analytical, testing capacity, method, reference standard, stability, vendor, and regulatory risks that could impact Phase 3 clinical supply or commercial readiness; develop and drive mitigation and contingency strategies.
• Provide clear scientific assessments, risk evaluations, recommendations, and decision options to CMC and senior management.
• Track key analytical deliverables, timelines, risks, and external partner performance and ensure timely escalation and resolution of issues.

REQUIRED EDUCATION AND EXPERIENCE:

• Ph.D., M.S., or B.S. in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, Biology, or a related scientific discipline.
• 10+ years of progressive biopharmaceutical industry experience in analytical development, characterization, Quality Control, and/or CMC development; equivalent combinations of education and experience will be considered.
• Demonstrated experience supporting late-stage biologics development, including Phase 3 programs and progression toward regulatory filing and commercial readiness.
• Significant experience developing and implementing analytical strategies for biologic drug substance and/or drug product.
• Experience with monoclonal antibodies, recombinant proteins, or other biologic products.
• Demonstrated experience with analytical method development, qualification, validation, transfer, and lifecycle management.
• Experience supporting product characterization, specifications, stability, comparability, and process validation/PPQ.
• Demonstrated experience managing analytical activities at external CROs, CDMOs, and/or testing laboratories.
• Experience supporting analytical investigations, troubleshooting, OOS/OOT assessments, and change management in a regulated environment.
• Working knowledge of ICH, FDA, EMA, cGMP, and biologics analytical regulatory requirements.

Technical Expertise

• Analytical method development, qualification, validation, transfer, and lifecycle management.
• Biologic drug substance and drug product characterization.
• Chromatographic methods including HPLC/UPLC, SEC, ion-exchange chromatography, and reversed-phase chromatography.
• Electrophoretic methods including CE-SDS, capillary isoelectric focusing/imaged CIEF, and related technologies.
• Mass spectrometry and other structural characterization methodologies.
• Protein concentration, identity, purity, and impurity testing.
• Aggregate and size-variant analysis; charge-variant analysis; glycan and post-translational modification characterization.
• Potency and biological activity assays, including appropriate cell-based and/or binding assays.
• Process- and product-related impurity testing, including host cell protein and residual DNA, as applicable.
• Stability-indicating methods and stability data interpretation.
• Analytical comparability strategies; reference standard qualification and lifecycle management; specification development and justification.

ADDITIONAL SKILLS, KNOWLEDGE, AND/OR ABILITIES:

• Strong scientific and technical leadership with sound analytical judgment.
• Ability to integrate complex analytical data into clear conclusions and development recommendations.
• Strategic thinking with the ability to anticipate analytical and regulatory risks.
• Demonstrated external partner management and ability to influence CROs/CDMOs without direct authority.
• Strong ownership, accountability, and action orientation in a lean, highly outsourced biotech environment.
• Excellent problem-solving, root-cause analysis, and decision-making skills.
• Strong cross-functional collaboration and project leadership.
• Ability to communicate complex scientific issues, risks, options, and recommendations clearly to technical and executive audiences.
• Strong regulatory, quality, and inspection-readiness mindset.

Preferred Qualifications

• Direct experience supporting a BLA and/or MAA for a biologic product, including preparation or review of analytical CMC sections and responses to health authority questions.
• Experience supporting successful PPQ campaigns, pre-approval inspection readiness, and transition to commercial manufacturing.
• Experience establishing late-stage and commercial specifications for biologic drug substance and drug product.
• Experience developing analytical comparability strategies supporting manufacturing process, scale, or site changes.
• Experience with potency assay development, qualification, validation, and lifecycle management for biologics.
• Experience supporting analytical activities across multiple global CRO/CDMO/testing sites.
• Experience with electronic laboratory systems, LIMS, digital data management, and analytical data platforms.

Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office. 

Travel: This position requires up to 30% domestic and international travel.