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Analytical Development Cmc Director Jobs (NOW HIRING)

Iambic Therapeutics, Inc

$224K - $310K/yr

JOB SUMMARY Iambic Therapeutics is seeking a Senior or Executive Director to lead the analytical development and QC function within CMC. This leadership role will provide scientific, strategic, and ...

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How much do analytical development cmc director jobs pay per year?

As of Sep 12, 2026, the average yearly pay for analytical development cmc director in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

What is an Analytical Development CMC Director?

An Analytical Development CMC (Chemistry, Manufacturing, and Controls) Director is a senior leader responsible for overseeing the development, validation, and implementation of analytical methods used to support the manufacturing and quality control of pharmaceutical products. They lead teams in designing and executing studies to ensure products meet regulatory standards for safety, efficacy, and quality. The CMC Director collaborates with cross-functional teams, manages analytical labs, and interfaces with regulatory agencies to support product approvals and lifecycle management. Their work is critical in ensuring that drug products are consistently produced and controlled according to quality standards.

What are the main challenges an Analytical Development CMC Director typically faces when leading cross-functional teams in pharmaceutical development?

An Analytical Development CMC Director often navigates challenges such as aligning priorities across R&D, quality control, and regulatory teams while ensuring analytical methods meet stringent compliance standards. Balancing project timelines with evolving regulatory requirements can be complex, especially in fast-paced environments. Effective communication and leadership are critical to harmonize efforts, resolve technical issues swiftly, and ensure data integrity throughout the drug development lifecycle. Building strong collaborative relationships is key to overcoming these obstacles and driving successful product development.

What are the key skills and qualifications needed to thrive as an Analytical Development CMC Director, and why are they important?

To thrive as an Analytical Development CMC Director, you need deep expertise in analytical chemistry, regulatory CMC requirements, and a background in pharmaceutical sciences, often supported by an advanced degree (Ph.D. or M.S.) and substantial industry experience. Familiarity with analytical instrumentation, GMP/GLP compliance, and software for data management and quality control is essential. Strong leadership, project management, and communication skills enable effective team coordination and cross-functional collaboration. These skills ensure the development of robust analytical methods, regulatory compliance, and timely advancement of drug products through the development pipeline.

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Infographic showing various Analytical Development Cmc Director job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $191,412 per year, or $92 per hour.

Senior Director, Analytical Development CMC

Boston, MA • On-site

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company
See more jobs at Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Companyexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 24 days ago

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate - cleminorexton (formerly ORX750) - is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
Description of Role
Centessa's CMC group is seeking a Senior Director of Analytical Development within the CMC group. The successful candidate will have hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development.
Reporting to the Executive Director, this role will drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross-functionally with drug substance and drug product teams across programs. Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount.
This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines. Travel to vendors both domestically and internationally will be required.
Key Responsibilities
  • Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs
  • Collaboratively work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors including method implementation, qualification/validation, and transfer in support of pre-IND through Registrational programs
  • Review method validation protocol and reports, and test data for release, stability, and characterization
  • Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments
  • Lead specification settings based upon batch history and supporting analytical data
  • Act as the CMC team analytical representative member in program development teams
  • Act as role model and subject matter expert for junior analytical scientists
  • Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, discriminatory and quality control dissolution method development, and structural elucidations
  • Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA, etc) as well as responses to Regulatory requests for information
  • Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting
  • Active participation in batch record review

Qualifications
  • Advanced degree in chemistry, pharmaceutical sciences, or related field (PhD strongly preferred)
  • 10+ years of small molecule pharmaceutical industry experience
  • Extensive experience in early phase analytical development of small molecule oral solid dosage forms
  • Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
  • Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities (e.g., genotoxic, nitrosamines), and forced degradation mechanisms
  • Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution
  • Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs
  • Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation)
  • Strong understanding of product quality attributes and control strategies for small molecule synthetic processes
  • Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization
  • Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments
  • Strong analytical planning, resource management, and budget oversight skills across global CDMO networks
  • Effective decision-maker and communicator, able to work independently while collaborating across functions and organizational levels

Compensation
The annual base salary range for the Sr. Director level position is $165,000.00 to $250,000.00.
Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
Work Location
The (Senior) Director, Analytical Development role is a based in the US, with occasional travel.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

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