200+ applicants

Company

Day One Biopharmaceuticals · 1 day ago

Director, CMC External Operations Biologics

United States

Full-time

Remote

Director/Executive

$200K/yr - $230K/yr

15+ years exp

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Responsibilities

Provide expert leadership in the process development of antibodies and ADCs, overseeing both strategic and executional activities at CDMO partners.

Provide operational and technical oversight for the Upstream cell culture and Downstream purification and formulation activities. Coordinate with the Analytical development teams to support ongoing GMP operations.

Lead and guide process characterization, validation studies, and technology transfer initiatives for antibody and protein-based therapeutics from early clinical phases through a successful global BLA filing and commercial manufacturing.

Work closely with the CDMO manufacturing facilities to ensure alignment in process development, scale-up, and manufacturing activities to meet project deliverables. Ownership of product campaign readiness, execution, and operational performance measures for CDMO partners.

Technical assessment and definition of site selection scale-up strategy for ADC manufacturing network.

Facilitate technology transfer and ensure consistency and scalability between sites, maintaining high-quality standards and regulatory compliance.

Coordination of complex investigations and process improvement opportunities, working closely with site MS&T organization on detailed data trend analysis and associated characterization work to be completed in support of process understanding and improvements.

Engage with Day One Bio ADC Product Team and associated R&D and Commercial functions to establish line of sight to program commercialization. Integrating CMC strategy for antibody/ADC development to achieve Target Product Profile (TPP).

Communication with partners to align on manufacturing feasibility, critical quality attributes (CQAs), and specifications throughout development.

Ensure the integrity, organization, and integration of CMC process development and scale-up datasets in support of regulatory submissions.

Compile and review CMC sections for IND, BLA, and other regulatory submissions.

Participate in Project and CMC development teams as required.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Monoclonal antibody productionCMC strategyProcess developmentGMP manufacturingTech transferUpstream cell cultureDownstream purificationRegulatory submissionsData analysisMandarin ChineseStakeholder managementTechnical writingCollaboration skills

Required

Ph.D. in biochemistry, immunology, pharmaceutical sciences, or a related field with at least 10+ years of manufacturing and MS&T experience in an industrial setting.

B.S or M.S. in a relevant field with at least 15+ years of manufacturing and MS&T experience in an industrial setting.

Direct site-focused monoclonal anti-body manufacturing experience and MS&T Upstream & Downstream experience strongly preferred.

Extensive expertise in CMC strategy and antibody or ADC drug development.

Expertise in developing, optimizing, troubleshooting, and tech transferring processes for antibodies or ADCs.

Significant experience interfacing with and providing effective oversight of GMP operations at CDMOs.

Deep understanding of the design, development, optimization, and tech transfer of antibody or ADC manufacturing processes.

Proficient in analyzing and interpreting complex datasets from multiple methodologies.

Demonstrated effectiveness in cross-functional and functional leadership roles with strong collaboration and stakeholder relationship management skills.

Proficient in drafting, reviewing, approving, and supporting regulatory filings and responses.

Comprehensive knowledge of ICH and FDA regulations and guidance for biologics and ADCs.

Flexible and 'hands-on' to navigate between strategic and technical roles.

Able to work in a fast-paced bio-tech environment while managing multiple projects.

Ability to create collaborative and trusting relationships internally and with external partners.

Excellent verbal and technical writing communication skills with the ability to communicate with vendors, internal teams (including management), and regulators.