Director, Analytical Development/QC

DIRECTOR, ANALYTICAL DEVELOPMENT/QC

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.

POSITION SUMMARY:

Day One Bio is seeking a strategic and technical leader to build and lead both the biologics and small molecule analytical development and quality control function in support of our Tovorafenib commercial product and pipeline of ADC novel therapies. The Director of Analytical Development & QC is responsible for defining the analytical method development strategy, product characterization and quality control for biologics across the drug development phases in a fully outsourced development model. The ideal candidate must have demonstrated analytical & QC experience across regulatory regions in establishing accepted product control strategies from clinical to global commercialization. This position will report to the SVP, Regulatory CMC and GMP Quality.

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 Technical Leadership:

· Lead and oversee the analytical development & QC function in developing robust phase-appropriate analytical methods for characterization and release of intermediates, active pharmaceutical ingredients, and drug product candidates in the pipeline.

· Lead and oversee analytical development in designing and developing robust phase-appropriate analytical methods for characterization and routine testing of materials.

· Execute the overall analytical development control strategy throughout development with robust analytical and biological methods for the characterization of starting materials, intermediates, products, and known/potential impurities.

· Guide critical quality attribute, specification, and control strategy development.

· Define product specifications and strategy for harmonization of specifications across global clinical and commercial supply chains.

· QC check CDMO generated raw data.

· Oversee characterization and control of reference standards, Track and trend stability data for ongoing studies, Independently and/or as part of a team, identify impurities and degradation products.

Collaboration with CDMOs:

· Leadership in the selection of CDMOs and contract laboratories for non-GMP/GMP development and manufacturing.

· Ensure phase appropriate method qualification and testing activities for biologic/small molecule products are available at qualified vendors.

· Oversee all analytical based activities at CDMOs by providing analytical development and testing guidance to ensure all analytical methodologies are robust and in compliance.

· Manage investigational testing and assist with deviations/investigations/CAPA’s as they pertain to both internal and external CDMOs quality management systems.

· Manage proposals and contracts for CDMOs.

Day One Bio Partner Interactions:

· Collaborate with cross-functional teams, including Process Chemistry, Formulation Development, mAb production, QA, and Regulatory, to ensure alignment of analytical methods and controls with overall project goals.

· In conjunction with other CMC members and QA, communicate product quality risks at all stages of development.

 Regulatory:

· Implement and maintain analytical testing procedures in compliance with regulatory requirements based on relevant guidance and accepted standard organizations (e.g., USP, EP, JP, etc.).

· Work closely with regulatory CMC to ensure that analytical methods and specifications meet all regulatory guidelines and are properly represented in regulatory filings.

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

QUALIFICATIONS

Education:

· Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 10+ years of BioPharma experience leading analytical development and QC of both large and small molecules within a CMC department.

· B.S or M.S in relevant field with 15+ years of BioPharma experience leading analytical development and QC of both large and small molecules within a CMC department.

 Experience:

· Demonstrated experience managing internal and external teams.

· Experience in Analytical Development, QC, and Global external laboratory oversight strongly preferred.

· Expertise in developing and validating phase appropriate analytical methods for both biologic and small molecules in early and late-stage product development.

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

· Deep and broad knowledge of analytical chemistry of biologics in support of drug substance and drug product release and stability method development, raw material control, in process control, and characterization

Knowledge/Skills/Abilities:

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

· Excellent leadership, communication, and project management skills.

· Demonstrated leadership of analytical development and QC teams 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 quality trending.

· Knowledgeable on current regulatory requirements and industry practices in the analytical development and QC functions.

· 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.

COMPENSATION AND BENEFITS

The salary range for this position is $200,00 - $230,000. 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.