This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Analytical Sciences and Attribute Characterization in the United States.
This is an exciting opportunity for an experienced analytical sciences leader to play a critical role in advancing innovative biologic therapies through clinical development and regulatory approval. The position focuses on driving analytical characterization and comparability strategies for complex monoclonal antibody and combination biologics programs within a fast-paced biotechnology environment. Working cross-functionally with analytical, process development, regulatory, and external manufacturing partners, you will help ensure robust product understanding and regulatory readiness across multiple development stages. This role combines strategic oversight with hands-on scientific leadership, offering strong visibility and impact across the organization. The ideal candidate will thrive in a collaborative, science-driven culture focused on innovation, operational excellence, and accelerating meaningful therapies for patients. It is an excellent opportunity for someone who enjoys solving complex analytical challenges while contributing to the growth of a dynamic clinical-stage pipeline.
Accountabilities:
- Lead and oversee analytical characterization and comparability strategies for biologics programs, ensuring alignment with clinical development and regulatory objectives.
- Provide technical expertise in molecular characterization of monoclonal antibodies and combination biologics using advanced analytical techniques, including mass spectrometry, chromatographic methods, biophysical characterization, and functional assays.
- Collaborate closely with internal analytical development, process development, quality, and regulatory teams to support formulation, manufacturing, and submission activities.
- Manage characterization and comparability activities conducted through global CDMO partners, including review and approval of protocols, reports, analytical data packages, and study outcomes.
- Support development of analytical control strategies and contribute scientific content for regulatory filings such as INDs, CTAs, BLAs, and MAAs.
- Ensure analytical activities comply with FDA, EMA, ICH, and industry standards while maintaining scientific rigor and data integrity.
- Establish and implement best practices related to structure-function analysis, critical quality attribute assessment, post-translational modification analysis, and product comparability.
- Contribute to broader analytical development and quality control initiatives, including method development support, investigations, and stability or release data review.
Requirements:
- Advanced degree in Mass Spectrometry, Analytical Chemistry, Biophysical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
- Minimum of 8 years of biopharmaceutical industry experience within biologics analytical development, formulation development, or process development environments.
- Strong expertise in analytical characterization and comparability studies for protein biologics and monoclonal antibodies.
- Proven experience supporting global regulatory submissions, including IND, CTA, BLA, or related filings.
- Deep understanding of advanced analytical methodologies such as LC-MS/MS, SPR, capillary electrophoresis, chromatography, particle analysis, and cell-based functional assays.
- Demonstrated ability to lead cross-functional scientific initiatives and manage deliverables in a fast-paced development environment.
- Experience working with CDMOs and external partners to execute analytical and comparability programs effectively.
- Familiarity with AI and machine learning applications that enhance analytical workflows, data analysis, or attribute trending is highly valued.
- Excellent communication, leadership, organizational, and problem-solving skills with the ability to influence across multidisciplinary teams.
- Previous experience with mAb combination products and device-related testing is considered an advantage.
Benefits:
- Competitive salary range of $175,000 to $190,000, depending on experience, qualifications, and geographic location.
- Performance-based bonus opportunities and equity participation.
- Comprehensive healthcare, welfare, and retirement benefits package.
- Unlimited paid time off policy.
- Two company-wide one-week shutdowns annually.
- Flexible remote work environment with opportunities for in-person collaboration and team engagement.
- Professional development and career growth opportunities within an innovative biotechnology setting.
- Opportunity to contribute directly to the advancement of impactful therapies in a collaborative and mission-driven environment.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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