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Associate Director, Analytical Development, Quality Control
Uniquity Bio. Lead analytical development and quality control activities supporting development, characterization, manufacturing, and regulatory approval of biopharmaceutical products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical development and quality control for biopharmaceutical products, including method qualification, validation, and regulatory submissions. Proficient in managing analytical activities and collaborating with internal teams and external partners to ensure compliance with GMP and regulatory standards.
Highest-signal resume keywords
Analytical Method DevelopmentBiologics Analytical Method QualificationGMP ComplianceRegulatory SubmissionsProtein Chemistry
ATS Keywords
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Hard Skills
Analytical ChemistryBiochemistryBiological AssaysDrug Substance Release TestingStability TestingComparability AssessmentsLate-Stage Monoclonal Antibody DevelopmentAnalytical Documentation ReviewLifecycle ManagementTechnical Report Authoring
Soft Skills
Excellent Communication SkillsProblem-Solving SkillsCritical-Thinking SkillsNegotiation SkillsCollaboration
Industry Keywords
Biopharmaceutical IndustryGMPRegulatory GuidanceCMC SectionsPPQBLADrug-Device Combination ProductsContract LaboratoriesReference Standard LifecycleQuality Control
About the role
Key responsibilities & impact- Lead analytical development and quality control activities supporting development, characterization, manufacturing, and regulatory approval of biopharmaceutical products
- Develop and implement robust analytical methods across the product development lifecycle
- Lead analytical method qualification, validation, and transfer for drug substance and drug product release and stability testing
- Oversee GMP and non-GMP stability studies
- Manage the reference standard lifecycle and two-tier reference standard system
- Review and approve QC raw data and analytical documentation packages
- Lead late-stage product characterization studies supporting CQA identification and product control strategy development
- Oversee drug substance and drug product comparability assessments
- Collaborate with internal teams, CMOs, and contract laboratories
- Maintain knowledge of GMP requirements, regulatory guidance, and industry best practices
- Author and review technical reports, analytical documentation, and CMC sections of global regulatory submissions
- Proactively identify and resolve technical and quality challenges
- Support analytical readiness for product commercialization
- Report to the Sr. Director, Analytical Development and Quality Control
Requirements
What you’ll need- Bachelor's degree or higher in analytical chemistry, biochemistry, or a related scientific discipline
- At least 10 years of experience in the biopharmaceutical industry
- Strong scientific foundation in protein chemistry, analytical methods, and biological assays
- Significant experience in analytical development and/or quality control within the biopharmaceutical industry
- Expertise in biologics analytical method development, qualification, transfer, validation, and lifecycle management
- Understanding of pharmaceutical and biopharmaceutical manufacturing processes
- Experience in late-stage monoclonal antibody (mAb) drug product development preferred
- Experience preparing and supporting analytical deliverables for PPQ and BLA submissions preferred
- Experience with drug-device combination products preferred
- Experience managing analytical activities and deliverables with CMOs and contract laboratories preferred
- Ability and willingness to travel domestically and internationally
- Ability to influence stakeholders, build effective working relationships, and drive alignment across internal teams and external partners
- Excellent written and verbal communication skills
- Strong problem-solving, critical-thinking, and negotiation skills
- Ability to work independently and collaboratively
- Self-motivated in a complex, collaborative, fast-paced environment
Benefits
Comp & perks- Equal Opportunity Employer committed to diversity and an inclusive environment
- Opportunity to make a meaningful impact while working alongside a talented, agile team
- Collaborative and transparent work environment
- Ability to work remotely for eligible employees, with office access and regular office travel expectations
- Business travel opportunities/requirements depending on position needs