Associate Director, Analytical Development

2 weeks ago


Boston, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

Associate Director, Analytical Development

Our client is seeking an accomplished leader to join our team as Associate Director, Analytical Development (Small Molecules). This role will drive analytical strategy and execution for late-phase development programs, ensuring robust data packages to support NDA submissions and eventual commercialization. The ideal candidate brings deep expertise in small molecule analytical methods, regulatory expectations, and cross-functional collaboration to deliver high-quality CMC data.

Key Responsibilities

  • Analytical strategy for late-phase programs
    : Develop and implement analytical plans aligned with NDA submission timelines and regulatory requirements.
  • Method validation & transfer
    : Lead validation of chromatographic, spectroscopic, and dissolution methods per ICH/FDA guidelines; oversee method transfers to QC/manufacturing sites.
  • Stability & release testing
    : Ensure comprehensive stability studies and product release testing packages are generated and interpreted.
  • Regulatory documentation
    : Author and review analytical sections of IND amendments, NDA filings, and responses to regulatory queries.
  • Cross-functional leadership
    : Partner with Formulation, Process Development, Quality, and Regulatory Affairs to ensure analytical deliverables meet program milestones.
  • Team management
    : Mentor scientists, set priorities, and foster technical excellence in method development and validation.
  • Inspection readiness
    : Prepare analytical teams and documentation for pre-approval inspections (PAI).
  • Innovation & compliance
    : Evaluate new technologies (e.g., LC-MS, UPLC) while ensuring strict adherence to GMP and data integrity standards.

Qualifications

  • Ph.D. or M.S. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
  • 10+ years in small molecule analytical development, with significant late-phase/NDA submission experience.
  • Strong background in HPLC/UPLC, LC-MS, dissolution, impurity profiling, and stability testing.
  • Proven track record authoring CMC sections of NDAs; deep familiarity with ICH Q2(R2), FDA guidance, and global regulatory expectations.
  • Demonstrated ability to lead teams, manage timelines, and influence cross-functional stakeholders in a matrixed environment.


  • Boston, Massachusetts, United States Olema Oncology Full time $215,000 - $230,000

    Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product...


  • Boston, Massachusetts, United States Temple Israel of Boston Full time

    Temple Israel of Boston is widely recognized as the largest Reform temple in New England, and it is one of the most prominent synagogues in the greater Boston area. At Temple Israel, our mission of "Living Judaism Together" means that we acknowledge, welcome, and honor each individual in our community for who they are. Temple Israel is known for offering an...


  • Boston, Massachusetts, United States Fidelity Investments Full time $161,803 - $194,000

    Job Description:Position Description:Transforms data into business insights, using structured and unstructured data sources (including digital interactions, customer feedback, chat/call transcripts, customer profile attributes, platform logs, operational metrics, and financial transactions). Drives improvements to the digital experience for customers and...


  • Boston, Massachusetts, United States Planet Fitness Full time

    About UsFounded in 1992 in Dover, NH, Planet Fitness is one of the largest and fastest-growing franchisors and operators of fitness centers in the United States by number of members and locations. We have over 2,700+ stores in 50 states, the District of Columbia, Puerto Rico, Canada, Panama, Mexico, Spain, and Australia. 90% of Planet Fitness stores are...


  • Boston, Massachusetts, United States Vertex Inc. Full time $192,000 - $288,000

    Job DescriptionGeneral Summary:Vertex is seeking to hire an experienced individual to lead the Cell & Gene Therapy (CGT) Disease Area (DA) pillar within the North America Forecasting, Analytics & Insights team, in the North America Commercial Organization. The Director, Forecasting, Analytics & Insights (CGT) will serve as a member of the hemoglobinopathies...


  • Boston, Massachusetts, United States Marketbridge Full time

    This is a remote role, required to work in EST hours.Who We AreMarketbridge is a leading integrated growth consulting and marketing services firm that accelerates performance from strategy through execution. We combine management consultancy with marketing agency expertise, all backed by marketing science, creative problem-solving, and technological...


  • Boston, Massachusetts, United States AstraZeneca Full time

    The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across multiple product portfolios...


  • Boston, Massachusetts, United States Inside Higher Ed Full time

    ASSOCIATE DIRECTOR, STEWARDSHIP PROJECT MANAGEMENT, Development & Alumni Relations, Donor*Job DescriptionASSOCIATE DIRECTOR, STEWARDSHIP PROJECT MANAGEMENT, Development & Alumni Relations, DonorCategory*Charles River Campus --> ProfessionalJob LocationBOSTON, MA, United StatesTracking Code Posted Date11/12/2025Salary GradeGrade 49Expected Hiring Range...


  • Boston, Massachusetts, United States AstraZeneca Full time $126,000 - $190,000

    The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across multiple product portfolios...


  • Boston, Massachusetts, United States GYK Full time

    Hey, we're GYK — an independent, integrated creative agency. Our Creative Growth Engine is made up of 65 creative entrepreneurs, modern storytellers, Emmy-award-winning makers, and data-driven problem solvers who believe creativity is a strategic lever for growth. To us, autopilot is the enemy — the enemy of growth, the enemy of standing out, the enemy...