Vice President, CMC Technical Operations

VICE PRESIDENT CMC TECHNICAL OPERATIONS    

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically 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.

POSITION SUMMARY:                

Day One Bio is seeking a strategic technical operations leader to define and execute on a supply strategy encompassing commercial small molecule and clinical ADC portfolio. The VP of CMC Technical Operations will lead a team to ensure reliable supply of OJEMDATM to all patients and expand access through the support of global launch activities.  In addition, this position is accountable for leading process development and MS&T scale-up plans to enable advancement of Antibody Drug Conjugate (ADC) pipeline assets  from early stage clinical studies to late stage clinical and product commercialization.  The ideal candidate will have extensive experience in oral small molecules and Biologics/ADCs, an in-depth understanding of CMC regulatory requirements, and a proven track record of leading manufacturing site operations and/or effectively working with global CDMOs to deliver right-first-time performance. This is a hands-on leadership role, requiring a candidate who is willing to roll up their sleeves and actively drive projects forward, build operational business processes, expand the CMC technical operations team, and establish global performance measures and oversight model for our network of CDMOs. This position will report to the Chief Technology Officer.

This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future opportunities and challenges.  The core areas for strategic leadership include:

Technical and Operational Leadership:

·       Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectives.

·       Provide expert leadership and strategic direction for CMC-related activities including process development and manufacturing of small molecules and ADCs (Biologics/mAb, conjugation, formulation/sterile filling & lyophilization), overseeing both strategic and executional activities at CDMO partners.

·       Oversight of CDMO operational execution and technical support.  Technical support may include campaign readiness, process changes, complex investigations, and batch release activities.

·       Define multi-year, continuous improvement plan that drives a continuous improvement culture, outlining initiatives to optimize manufacturing processes, cost-effectiveness, and scalability for commercial production.

·       Lead and guide next generation process designs and technology transfers for portfolio of products in support of defined lifecycle opportunities (i.e from early clinical phases through global NDA/BLA/MAA filing approvals and post-launch commercial supply network).

·       Lead CMC technical due diligence on Business Development opportunities.

·       Build and develop staff for future roles and career progression.

·       Ensure a culture of safety and right-first-time Quality.

Collaboration with CDMOs:

·       Establish operational performance measures in partnership with CDMO network for all phases of product lifecycle (i.e. clinical and commercial) and ensure adherence to contractual requirements.

·       Work closely with the CDMO manufacturing facilities to ensure alignment in process development, scale-up, and manufacturing activities to meet program deliverables and ensure alignment on financial considerations.

·       Ensure alignment of Day One Bio program needs with CDMO capacity and capabilities, and defining clear points of decision making that requires flexibility in operational deliverables.

·       Provide leadership to internal team and CDMOs to align on technology transfer plans and ensure consistency and scalability between sites, maintaining high-quality standards and with a clear line of sight to data packages that support regulatory compliance and filing requirements.

·       Work with team and CDMO technical/MS&T organization on detailed data trend analysis and associated characterization work to be completed in support of process understanding, regulatory reporting and submission, and process improvements.

Day One Bio Partner Interactions:

·       Day One Bio Product Team member to engage with associated R&D and Commercial functions to establish line of sight to program commercialization and lifecycle management.  Lead CMC cross-functional team to establish CMC strategy for program 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:

·       Lead team of SMEs to author Module 3 content for BLA submissions and technical responses to Regulatory Authority inquiries.  Outline overall strategy for process development/MS&T data packages to meet BLA requirements for BLA submissions.  Work closely with regulatory CMC to ensure that Module 3 information meet all regulatory guidelines and are properly represented in regulatory filings.

·       Implement and maintain processes in communication with CDMOs to ensure compliance with regulatory requirements based on relevant guidance and accepted standard organizations (e.g., USP, EP, JP, etc.).

·       Review for IND, BLA, and other regulatory submissions to include all relevant data and documentation in support of clinical/commercial products.

·       Serve as a key CMC representative in meetings with Regulatory Health Authorities, partners, and internal stakeholders.

QUALIFICATIONS

 Education:

·       Ph.D. in biochemistry, immunology, pharmaceutical sciences, or a related field with at least 15+ years of Operations and Technical Operations experience in an industrial setting.

·       B.S or M.S. in a relevant field with at least 20+ years of Operations and Technical Operations experience in an industrial setting.

 Experience:

·       Direct site GM experience, with previous site leadership roles in QA, Manufacturing, and Technical Operations/MS&T.

·       Extensive expertise in CMC strategy and ADC/Biologics drug development and operations.

·       Deep expertise in developing, optimizing, troubleshooting, and tech transferring processes for Biologics and/or ADCs.

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

·       Experienced in technology and/or process transfer for late-stage clinical manufacturing and commercial qualification campaigns.

·       Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement

Knowledge/Skills/Abilities:

·       Develop team members, both internally and at selected partners, to continually improve their technical capabilities.

·       Excellent leadership, communication, and project management skills.

·       Demonstrated leadership of manufacturing and technical operations both internally and externally.

·       Generate and analyze data to guide critical decision making within CMC which could include the use of statistical analysis and data mining for trending.

·       Knowledgeable on current global regulatory requirements and industry.

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

·       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.

·       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.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $300,000 - $340,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

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.