The Head 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 Dose and parenteral Drug Product programs. The incumbent will have deep experience in analytical activities required to support early-stage to late-stage drug substance as well as 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 will 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, this leader will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, , Regulatory Affairs, Quality Assurance, and external CDMOs/CROs/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
- Build and lead a small team of analytical development and quality control chemists capable of developing and executing phase-appropriate analytical method development and testing strategies and activities supporting Chemical and Drug Product development and eventual commercialization of the Treeline portfolio, including:
- Phase-appropriate small molecule drug substance method development and testing
- Phase-appropriate small molecule oral dose drug product method development and testing (tablets, capsules, gelcaps, pediatric formulations, etc.)
- Phase-appropriate small molecule oral dose drug product intermediate method development and testing (e.g. amporphous solid dispersions)
- 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.
Quality Control Oversight
- Establish and lead QC strategies across clinical manufacturing operations
- 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.
- 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 Small molecule Drug Substance and Drug Product development and manufacturing with emphases on oral solid dose, parenteral, and pediatric formulations.
- Demonstrated success in developing and validating discriminating dissolution methods for 1+ OSD tablets.
- 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 desirable.
Technical Expertise
Strong working knowledge of:
- Analytical method development and validation
- Stability programs and specification setting
- Quality control laboratory operations
- GMP analytical testing
- Small molecule drug substance characterization and phase-appropriate method development.
- Oral solid dose characterization and phase-appropriate method development, including discriminatory dissolution method development
- ADC analytical characterization
- Experience with Biologics testing methodologies desirable
- Strong command of and facility working with relevant ICH quidances
- 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 the role is $234,500 to $286,338. 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.
Recruitment fraud statement
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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.