Cogent Biosciences

Cogent Biosciences

Associate Director, Analytical Development

Remote, United States · Director

Sponsorship not specified$180k-$210kDetected 1 day ago
Project ManagementFDA RegulatoryScientific WritingResearchMass SpectrometryLeadershipCommunicationProblem SolvingWritingOrganizational Skills

> stay_score

odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

Personalize to your clock →

> community_outcomes

No reports yet — be the first to help the next applicant.

About the role

  • The Associate Director, Analytical Development, is responsible for leading analytical activities across Cogent's development portfolio and commercial product.

Responsibilities

  • Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation.
  • Partner closely with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of analytical documentation and reports.
  • Support analytical method development, validation, qualification, transfer, and lifecycle management activities across development and commercial programs.
  • Author, review, and manage technical documents including analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation.
  • Collaborate with external laboratories and CDMOs to ensure analytical deliverables are scientifically sound, compliant, and aligned with program timelines.
  • Drive continuous improvement initiatives focused on analytical reporting processes, data integrity, document quality, and operational efficiency.
  • Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection.

Requirements

  • Experience in analytical development, analytical reporting, CMC technical writing, or related pharmaceutical development functions.
  • Strong understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies.
  • Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories.
  • Working knowledge of analytical techniques such as HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and related pharmaceutical characterization methods.
  • Familiarity with ICH, FDA, EMA, and other global regulatory requirements related to analytical development and CMC documentation.
  • Excellent verbal and written communication skills with the ability to effectively communicate complex technical information to diverse audiences.
  • PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant industry experience, OR Master's degree with 10+ years of experience, OR Bachelor's degree with 12+ years of experience.
  • Demonstrated experience authoring, reviewing, and approving technical documents including analytical methods, protocols, reports, and regulatory-supporting documentation.
  • Strong scientific writing, data interpretation, problem-solving, and project management skills.
  • Proven ability to work effectively within a cross-functional matrix organization and build strong relationships with internal stakeholders and external partners.
  • Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment.

Nice to have

  • Experience supporting late-stage development or commercial programs.
  • Experience contributing to IND, NDA, MAA, or other global regulatory submissions.

Compensation

  • $180,000 - 210,000 USD
  • Exact compensation will vary based on skills, experience, and location.
  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s us apart.

Benefits

  • Support the preparation and review of CMC sections for regulatory submissions, responses to health authorities, and other regulatory filings.
  • Target Bonus: 20%
  • We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles.
  • A dditional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
  • Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.

Company info

  • Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
  • The Role:
  • The Associate Director, Analytical Development, is responsible for leading analytical activities across Cogent's development portfolio and commercial product. This role within CMC will partner closely with Regulatory CMC, Quality, and external CDMOs to ensure analytical data, reports, methods, specifications, and regulatory-supporting documentation are accurate, phase-appropriate, and aligned with program objectives. The successful candidate will provide technical leadership in the review, interpretation, and communication of analytical results while ensuring high-quality documentation supports development, commercialization, and global regulatory submissions.
  • Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs.
  • Cogent's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V.
  • KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling.
  • Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
  • This role within CMC will partner closely with Regulatory CMC, Quality, and external CDMOs to ensure analytical data, reports, methods, specifications, and regulatory-supporting documentation are accurate, phase-appropriate, and aligned with program objectives.
  • The successful candidate will provide technical leadership in the review, interpretation, and communication of analytical results while ensuring high-quality documentation supports development, commercialization, and global regulatory submissions.
  • Bezuclastinib has exhibited promising initial data across all three trials:
  • APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.

Equal opportunity

  • We are proud to be an Equal Opportunity Employer.
  • Our goal is to have a diverse workforce.
Apply directly at Cogent Biosciences →Create a free account for alerts like thisView Cogent Biosciences immigration profile

This listing is sourced directly from Cogent Biosciences's careers page and normalized into a canonical job model.