Associate Director, Analytical Development & CMC

Jobtailor; Boston (MA); On-site; USD 180,000 - 235,000; Full time

Job summary

Jobtailor in Boston is seeking a senior Analytical Development leader to design phase-appropriate strategies and oversee method development, qualification, and validation for drug substances and products from preclinical through Phase 3.

You will guide internal and external teams to ensure GLP and cGMP compliance, prepare regulatory submissions (IND/IMPD/CTA/NDA/MAA), and oversee CRO/CDMO activities while driving timely GMP release. Travel up to 25%.

Qualifications

• Ph.D. or M.Sc. in analytical chemistry or closely-related field.
• 10+ years of directly-related industry experience.
• Experience with analytical development of small molecules and solid oral dosage forms from preclinical through Phase 3.
• Extensive analytical method development, troubleshooting, and validation experience.
• In-depth experience with HPLC, GC, dissolution, compendial methods, impurity and degradation-product identification, and reference standard qualification.
• Knowledge of drug development, CDMO management, manufacturing, and regulatory CMC.
• Extensive knowledge of cGMP-related regulations, guidance, principles, and best practices for drug substances and drug products.
• Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices.
• Experience preparing and updating IND, IMPD, CTA, NDA, and MAA regulatory filings.
• Experience managing projects and FTEs at GMP testing CROs.
• Ability to organize and prioritize tasks to meet deadlines.
• Ability to multitask and adapt to changing business requirements.
• Proven problem-solving skills.
• Excellent oral and written communication, leadership, and interpersonal skills.
• Ability to travel up to 25% domestically and internationally.
• Ability to work onsite at the Boston office a minimum of two days per week.

Responsibilities

• Develop analytical methodologies and characterization activities for drug substances and products.
• Provide regulatory and corporate guidance to ensure GLP/cGMP compliance.
• Support analytical aspects for preclinical, clinical, registrational, validation, and commercial batches.
• Design and execute phase-appropriate analytical strategies with cross-functional teams.
• Manage method development, optimization, qualification, and validation for starting materials, intermediates, and products.
• Identify and recommend analytical methodologies for development, QC, and stability testing.
• Oversee CRO/CDMO analytical activities including transfer and validation.
• Review raw data packages to ensure GLP/cGMP compliance.
• Resolve technical issues; review deviations, OOS, and OOT investigations.
• Collaborate with QC/QA for timely GMP release of lots.
• Author/review analytical sections of CMC regulatory submissions.
• Represent Analytical Development in CMC teams and meetings.
• Maintain knowledge of drug-development issues and regulatory guidance.
• Ensure adherence to company policies by direct reports.
• Travel domestically and internationally up to 25%.
• Perform other duties as assigned

Skills

Analytical Method Development

HPLC

GC

Dissolution Testing

Impurity Identification

Degradation-Product Identification

Reference Standard Qualification

Regulatory CMC Knowledge

Project Management

Leadership

Communication Skills

GLP/cGMP Knowledge

Education

Ph.D. in Analytical Chemistry

Job description

Jobtailor in Boston is seeking a senior Analytical Development leader to design phase-appropriate strategies and oversee method development, qualification, and validation for drug substances and products from preclinical through Phase 3.

You will guide internal and external teams to ensure GLP and cGMP compliance, prepare regulatory submissions (IND/IMPD/CTA/NDA/MAA), and oversee CRO/CDMO activities while driving timely GMP release. Travel up to 25%.