SENIOR DIRECTOR, ANALYTICAL DEVELOPMENT & QUALITY CONTROL

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:

The Senior Director of Analytical Development & Quality Control (QC) will lead the strategy and execution of analytical development and QC activities across biologics, small molecules, and antibody-drug conjugates (ADCs), supporting both pipeline programs and the commercial product OJEMDA^TM.

This role will define the analytical control strategy from early development through commercialization, ensuring robust product characterization, validated methods, and global regulatory compliance. Operating within an outsourced model, the Senior Director will oversee CDMOs/CMOs, ensuring scientific rigor, data integrity, and quality standards across release and stability testing programs. This position will report to the Vice President, CMC Technical Operations.

As part of the CMC Technical Operations leadership team, this leader will drive innovation, inspection readiness, and cross-functional alignment with Quality Assurance, Regulatory, and Supply Chain.

This position has the potential to be fully remote. Occasional travel of 10% will be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Analytical Strategy & Leadership

• Lead the design, development, and implementation of phase-appropriate analytical methods for characterization, release, and stability testing of intermediates, APIs, and drug products.
• Define and execute analytical control strategies, identifying CQAs and establishing specifications across modalities (biologics, small molecules, ADCs).
• Oversee lifecycle management of analytical methods, ensuring compliance with ICH, FDA, and EMA standards.
• Drive continuous improvement and analytical innovation across programs.

External Partner Management

• Provide technical oversight for global CDMOs and contract labs performing method development, validation, and GMP testing.
• Ensure analytical methods and specifications are scientifically sound, validated, and aligned with CMC and regulatory expectations.
• Support investigations, deviations, and CAPAs across internal and external quality systems.

Cross-Functional Collaboration

• Partner with CMC, QA, Regulatory, and Process Development teams to ensure analytical strategies align with overall development and manufacturing objectives.
• Communicate quality risks and mitigation plans across functions and lifecycle stages.

Regulatory & Compliance

• Lead the authoring and review of analytical sections in INDs, BLAs, NDAs, and other regulatory submissions.
• Serve as the analytical SME in health authority interactions and inspections.
• Maintain alignment with evolving regulatory and pharmacopeial standards (USP, EP, JP).

QUALIFICATIONS

• PhD. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 12+ years of experience, or
• S./M.S. with 15+ years in analytical development, QC, and CMC leadership across biologics and small molecules.
• Proven leadership in analytical development and QC within global CDMO/CMO networks, including biologics, small molecules, and ADC modalities.
• Extensive experience with method development, qualification, and validation across development stages.
• Deep technical expertise in analytical chemistry for small molecules and biologics, including biophysical characterization, to support drug substance and drug product release, stability studies, raw material control, and in-process testing.
• Skilled in managing and mentoring technical staff, fostering innovation, and ensuring excellence across internal and partner organizations.
• Demonstrated success in regulatory interactions and authoring analytical sections of INDs, BLAs, NDAs, and global filings.
• Strong data analysis and decision-making skills.
• Excellent communication, collaboration, and leadership abilities.
• Ability to thrive in a remote, fast-paced, fully outsourced biotech environment.

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 $255,000 - $270,000. 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.

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.