Associate Director, CMC, Analytical Development

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

• Develop analytical methodologies and perform characterization activities for new drug substance and drug product development and manufacturing
• Provide guidance and support to internal and external groups to ensure regulatory and corporate-policy compliance, including GLP and cGMP
• Provide analytical support for preclinical, clinical, registrational, validation, and commercial batches
• Design and execute phase-appropriate analytical strategies with cross-functional project teams
• Manage analytical method development, optimization, troubleshooting, qualification, and validation for starting materials, process intermediates, drug substances, and drug products
• Identify and recommend analytical methodologies for chemical development, formulation development, QC, and stability testing
• Manage CRO/CDMO analytical activities, including method development, qualification/validation, transfer, and characterization testing
• Review analytical raw data packages and ensure GLP/cGMP compliance
• Resolve technical issues and review deviations, failure investigations, OOS, and OOT investigations
• Collaborate with Quality Control and Quality Assurance for timely GMP release of drug substance and drug product lots
• Author and review technical documents covering validation, transfer, reference standards, impurity characterization, and stability
• Author and review analytical sections of CMC regulatory submissions
• Represent Analytical Development in CMC teams and interdepartmental meetings
• Maintain current knowledge of drug-development issues, Competent Authority regulations, guidance, and industry trends
• Follow company policies and ensure direct reports follow them, if applicable
• Travel domestically and internationally up to 25%
• Perform other duties as assigned

Requirements

• Ph.D. or M. Sc. in analytical chemistry or a 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

Core Competencies

Demonstrates extensive expertise in analytical method development, validation, and troubleshooting for drug substances and products, with a strong focus on compliance with cGMP and GLP regulations. Proven ability to manage cross-functional teams and projects while ensuring timely regulatory submissions and adherence to industry standards.

Highest-signal resume keywords

• Analytical Method Development
• HPLC and GC Expertise
• Regulatory CMC Knowledge
• Project Management in GMP Environments
• Leadership and Communication Skills

Hard Skills

• Analytical Method Development
• Validation and Qualification
• HPLC
• GC
• Dissolution Testing
• Compendial Methods
• Impurity Identification
• Degradation-Product Identification
• Reference Standard Qualification
• Regulatory Filing Preparation

Soft Skills

• Problem-Solving Skills
• Organizational Skills
• Interpersonal Skills
• Leadership Skills
• Adaptability

Industry Keywords

• CGMP
• GLP
• Drug Development
• CDMO Management
• IND
• IMPD
• CTA
• NDA
• MAA
• Quality Control