Director – Analytical Development & Quality Control

Position Summary

The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule Oral Solid Dose (OSD) and parenteral Drug Product programs.  The incumbent will have deep experience in analytical activities required to support early-stage to late-stage oral solid dose and parenteral drug products. Additional experience in antibody/ADC manufacturing-focused analytical activities is desirable. This individual will be responsible for operating in a 100% outsourced environment to establish and manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs.

As a key member of the Technical Operations team, the Director will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CRO/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.

Key Responsibilities

Analytical Development Leadership

• Lead, develop and execute phase-appropriate analytical method development and testing strategies and activities supporting Drug Product development, with an emphasis on small-molecule OSD and large-molecule parenteral Drug Product analytical method development and testing for assigned programs, including:
• Phase-appropriate small molecule oral solid dose drug product method development and testing (tablets, capsules, gelcaps)
• Phase-appropriate method development supporting antibody manufacture, ADC conjugation, and parenteral drug product manufacture.
• Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.
• Ensure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions.
• Depending on experience, incumbent may serve as the company's analytical subject matter expert for ADC development.
• Support characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities.
• Guide implementation and interpretation of advanced analytical techniques such as:  HPLC, UPLC, LC-MS, HRMS, SEC, CE-SDS, icIEF, HIC, ELISA, and bioassays.
• Collaborate with external CDMOs and internal process development teams to define CQAs and control strategies for ADC products.

Quality Control Oversight

• Establish and lead QC strategies across clinical manufacturing operations for assigned programs.
• Oversee external GMP testing activities including raw materials, IPCs, release testing and stability programs.
• Ensure timely release and disposition support for clinical materials.
• Manage investigations involving OOS, OOT, deviations, and laboratory events.

Regulatory and Quality Support

• Author and review analytical sections of regulatory submissions including: INDs, IMPDs, BLAs, NDAs, and CTAs for assigned programs.
• Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations.
• Support establishment of specifications and analytical control strategies throughout the product lifecycle.
• May participate in regulatory agency interactions and inspections.
• Ensure compliance with cGMP, GLP, GCP, and data integrity requirements.
• Partner closely with Quality Assurance to maintain inspection readiness.
• Support audits of contract testing laboratories and manufacturing partners.

External Partner Management

• Manage relationships with contract laboratories and CDMOs.
• Oversee method transfers, validation activities, and technical governance of external laboratories.
• Establish performance metrics and ensure delivery against development and manufacturing timelines.
• Evaluate/implement new technologies/outsourced capabilities as needed.

Required Qualifications

Education

• Ph.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.

Experience

• 12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience.
•  Demonstrated deep experience in analytical development activities supporting Drug Product development and manufacturing with emphases on oral solid dose, parenteral, and pediatric formulations.
• Proven track record advancing products from early development through late-stage clinical development and/or commercialization.
• Demonstrated success working with CDMOs and global development partners.
• Additional experience in development and implementation of analytical methods to support antibody/ADC manufacturing is preferred.

Technical Expertise

Strong working knowledge of:

• Analytical method development and validation
• Stability programs and specification setting
• Quality control laboratory operations
• GMP analytical testing
• Oral solid dose characterization and phase-appropriate method development, including discriminatory dissolution method development
• ADC analytical characterization
• Experience with Biologics testing methodologies preferred
• ICH Q1, Q2, Q3, Q6, Q7, Q8, Q9, Q10, and Q14 guidance
• Regulatory submissions and health authority interactions

Leadership Competencies

• Strategic thinker with strong business and scientific acumen.
• Excellent project management and organizational skills.
• Strong communication and influence skills across scientific, quality, regulatory, and program teams
• Ability to travel (20%) to CDMO domestic and international sites.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project), iStability, and JMP (or similar statistical tools).
• High level of personal integrity, commitment to excellence and to our patients.
• Experience in developing and commercializing drugs for oncology is preferred.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $193,877 to $232,875. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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