Director, CMC Analytical

NewAmsterdam Pharma Corporation

Director, CMC Analytical overseeing analytical development and quality control at NewAmsterdam Pharma. Leading efforts in regulatory support, manufacturing readiness, and innovative technologies.

Posted 7/22/2026full-timeMassachusetts • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in analytical method development and validation for APIs and DPs, with a strong focus on regulatory compliance and quality control. Proven ability to lead analytical teams and manage relationships with contract manufacturing organizations while driving innovative technologies and quality-by-design approaches.

Highest-signal resume keywords

PhD In Analytical ChemistryAnalytical Method Development And ValidationRegulatory Documentation And ComplianceProject ManagementInterpersonal And Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical DevelopmentQuality ControlTesting MethodologyStability ProgramsRelease And Stability TestingData AnalysisSpecification EstablishmentTechnical Document AuthoringAnalytical Lifecycle ManagementQuality-By-Design (QbD)

Soft Skills

LeadershipNegotiationProblem-Solving

Industry Keywords

BiotechnologyPharmaceutical IndustryICH GuidelinesFDA RegulationsEMA GuidanceGMP RequirementsContract Manufacturing OrganizationsCommercializationLife Cycle ManagementSolid Oral Dose

About the role

Key responsibilities & impact

Spearhead the strategic direction and execution of analytical development, quality control, and analytical lifecycle activities for API and DP
Provide technical leadership and guidance to analytical development work, methods, and testing activities at CDMO
Oversee the establishment of testing methodology, specifications, and stability programs for raw materials, intermediates, excipients, APIs and DPs
Provide analytical leadership to support regulatory approval, commercial launch preparation, process validation, and continued process verification
Oversee API and DP release and stability testing as well as analytical regulatory documentation
Author and review technical documents, staying abreast of industry trends, regulations, and best practices
Drive the adoption of innovative technologies and quality-by-design (QbD) approaches
Work closely with other members of the CMC team to prioritize analytical activities across clinical-phase and commercial assets

Requirements

What you’ll need

PhD in analytical chemistry or a related field
at least 12 years of analytical team leadership in the biotechnology or pharmaceutical industry
Experience managing and building strong relationships with contract manufacturing organizations
Experience in early and late-stage programs, commercialization, commercial product support, launch transition, post-approval commitments, and life cycle management
Extensive technical expertise in analytical method development and validation for API and DP, characterization, and stability of solid oral dose
Proficiency in reviewing and analyzing release and stability data for trending, shelf-life, and specification establishment
Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
Proficient in writing RFPs, protocols, reports, and regulatory documents
Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills
Strong project management skills.

Benefits

Comp & perks

competitive base salary
annual bonus
long-term incentives
comprehensive benefits package
health insurance
dental and vision coverage
term life and disability coverage
retirement plans