Director, Process Chemistry and Drug Product

Atlas Venture; United States; Remote; USD 215,000 - 230,000; Full time

Job summary

A leading biopharmaceutical company seeks a Director of Process Chemistry and Drug Product to oversee the development and manufacturing of small molecule APIs and ADC products. This role offers strategic leadership and collaboration across teams, ensuring high-quality clinical materials and compliance with regulatory standards. The position is fully remote with occasional travel requirements.

Qualifications

• 10+ years of industry experience required.
• Experience authoring and reviewing CMC regulatory documents.

Responsibilities

• Provide strategic leadership for drug product manufacturing.
• Manage CMO relationships and ensure compliance with regulatory standards.
• Drive continuous improvement initiatives for manufacturing efficiency.

Skills

Project Management

Problem Solving

Cross-Functional Collaboration

Education

Ph.D. in Organic Chemistry

MS/BS in related discipline

Job description

Director, Process Chemistry and Drug Product

About Day One Biopharmaceuticals

Day One Biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine.

About Day One Biopharmaceuticals

Day One Biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine.

Job Description

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:

The Director, Process Chemistry and Drug Product will provide strategic leadership and technical oversight for the development, scale-up, manufacturing and technical transfer of small molecule APIs, ADC (antibody-drug conjugate) payload-linkers, and ADC conjugation, along with the formulation and manufacturing of lyophilized and liquid parenteral drug products.

This position will lead technical oversight of global CMOs/CDMOs, manage cross-functional collaborations, and ensure delivery of high-quality clinical materials in compliance with regulatory expectations. This role will be responsible for ensuring the seamless execution of API process chemistry and drug product manufacturing activities across the biopharmaceutical portfolio, collaborating closely with internal CMC, regulatory, quality, and supply chain teams.

As a key technical leader, the Director will drive CMC integrated lifecycle strategies, continuous improvement initiatives, technology transfers, and process validation to support clinical and commercial assets. Additionally, this individual will play a critical role in authoring regulatory documentation and ensuring compliance with global GMP standards.

This position reports to the Vice President of CMC Technical Operations and offers the flexibility of being fully remote, with occasional domestic and international travel (~10%) for in-person visits.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Small Molecule and ADC Process Chemistry

• Manage CMO relationships for small molecule manufacturing and ADC bioconjugation, including batch execution, deviation resolution, and continuous improvement activities.
• Provide technical oversight and troubleshooting for synthetic route development, impurity control, and process robustness.
• Lead development, optimization, scale-up, and technology transfer of small molecule APIs, payloads, linkers, and ADC bioconjugation.
• Author and review relevant sections of regulatory filings (IND, IMPD, NDA, MAA), including Module 3 process descriptions, control strategies, and comparability assessments.

Drug Product Development, Process Optimization & Manufacturing

• Provide technical leadership in the formulation, development, and manufacturing of biopharmaceutical (Antibody Drug Conjugates) parenteral drug products.
• Oversee formulation development and technical transfer of parenteral drug products (liquid and lyophilized), including early and late-stage process development.
• Manage fill-finish CMOs to ensure successful manufacturing campaigns, adherence to cGMP, and timely resolution of technical issues.
• Develop and manage risk-based strategies for oversight of CMOs, considering product lifecycle stage, complexity, and regulatory expectations.
• Partner with CMOs to manage deviations, investigations, and change control activities, ensuring rapid and effective resolution.
• Lead the selection and evaluation of second-source CMOs, assessing technical capabilities, quality systems, and compliance performance.
• Lead technology transfer activities, ensuring seamless scale-up and process validation for clinical and commercial liquid and lyophilized parenteral products.

Cross-Functional and Strategic Responsibilities

• Participate in CMC team meetings, regulatory meetings, and represent process chemistry and parenteral drug product technical operations.
• Develop risk assessments, technical plans, and manufacturing strategies to support clinical development and commercialization.
• Drive continuous improvement initiatives for manufacturing efficiency, yield enhancement, and cost reduction.
• Support the establishment of specifications, shelf-life assignments, stability studies, and comparability programs.
• Collaborate with Analytical Development, Quality, Regulatory, and Supply Chain to ensure product quality, compliance, and delivery timelines.

QUALIFICATIONS

• Ph.D. in Organic Chemistry, Process Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline with 10+ years of industry experience; MS/BS with 12+ years will be considered.
• Proven expertise in small molecule API development, ADC conjugation chemistry, and parenteral drug product formulation and manufacturing.
• Hands-on experience managing external CMOs/CDMOs for clinical and commercial supply.
• Strong understanding of cGMP, ICH guidelines, and global regulatory expectations for drug substance and drug product manufacturing.
• Excellent project management, problem-solving, and cross-functional collaboration skills.
• Experience authoring and reviewing CMC regulatory documents (INDs, IMPDs, NDAs, BLAs, MAAs).
• Ability to work in a fast-paced, dynamic environment with a proactive and solution-oriented mindset.

Preferred Qualifications

• Experience with lyophilization cycle development and optimization.
• Experience with payload-linker impurity profiling and analytical characterization.
• Familiarity with sterile manufacturing risk assessments (e.g., media fills, container closure integrity, visual inspection criteria).
• Prior experience in late-phase process validation (PPQ) and commercial readiness for ADC or small molecule parenteral products

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

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 $215,000 - $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.