Director, CMC External Operations Biologics

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

                                                                                

Day One Bio is seeking a strategic and technical leader to further build upon our expertise ADC pipeline development from early stage clinical studies to late stage clinical and product commercialization. The Director of CMC External Operation – Biologics is responsible for the leadership of external CDMO network to develop a robust monoclonal antibody process in support of advancing Day One Bio’s ADC clinical-stage asset.  The role requires direct oversight and engagement with CDMO Manufacturing, MS&T, and project management resources to ensure the successful development, scale-up, and GMP manufacturing of product in support of clinical supply requirements.   The incumbent will be accountable to define MS&T data packages and assessment of CDMO capabilities to support technology transfer and path to BLA submission through their expertise in monoclonal antibody production and process development.  This position will report to the VP, CMC.

 

This position has the potential to be fully remote. Occasional travel will be required for Corporate, CMC and CDMO meetings.

·       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.

 

 Regulatory:

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

·       Participate in Project and CMC development teams as 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.

 

 Experience:

·       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.

·       Language Skills: Mandarin Chinese is desired but not a requirement to collaborate with China CDMO partners.

 

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

The salary range for this position is $200,000 - $230,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

 

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.

 

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

 

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.