[Hiring] Director, Drug Product Technical Operations @Day One Biopharmaceuticals
Mar 21, 2025 - Day One Biopharmaceuticals is hiring a remote Director, Drug Product Technical Operations. 💸 Salary: $200,000 - $220,000. 📍Location: USA.
DIRECTOR, DRUG PRODUCT 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:
The Director, Drug Product Technical Operations will provide strategic leadership and technical oversight for clinical and commercial small molecule development and manufacturing operations within the global CMO/CDMO network. This role will be responsible for ensuring the seamless execution of drug product manufacturing activities across the oral solid dose 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:
Drug Product Development, Process Optimization & Manufacturing
- Provide technical leadership in the formulation, development, manufacturing, and labeling and packaging of small molecule drug products.
- Lead clinical and commercial solid oral dose operations, optimizing process control strategies and quality oversight.
- Oversee process characterization and optimization for non-sterile oral solid dose formulations (tablets, capsules, and non-sterile oral suspensions, including intermediates that deliver these end products such as spray drying, hot melt extrusion, blending, tableting, and film coating.
- Develop and implement risk-based process control strategies to ensure process robustness, manufacturability, scalability and regulatory compliance.
- Design, optimize, and scale formulations for drug products to support clinical trials; ensure stability, bioavailability, and manufacturability; define critical quality attributes and process parameters.
- Lead process scale-up efforts and validation for small molecule drug products.
- Partner with CMC, regulatory, quality, manufacturing, and supply chain teams to support lifecycle management; drive process improvements, cost efficiency, and adoption of new technologies.
CMO/CDMO Oversight & Technology Transfer
- Develop and manage risk-based strategies for oversight of CMOs, considering product lifecycle stage, complexity, and regulatory expectations.
- Oversee process and product monitoring plans, define and drive performance metrics, ensure alignment with quality systems and master documentation.
- Partner with CMOs to manage deviations, investigations, and change control activities, ensuring rapid and effective resolution.
- Serve as the technical lead for contract manufacturing oversight, ensuring adherence to GMP, ICH, and global regulatory requirements.
- Lead the selection and evaluation of second-source CMOs, assessing technical capabilities, quality systems, and compliance performance.
- Direct technology transfer activities, ensuring seamless scale-up and process validation for clinical and commercial oral solid dose products.
Operational & Regulatory Compliance
- Provide technical support for GMP manufacturing activities, including batch record reviews, deviation management, and lot disposition.
- Author/review CMC sections for IND, NDA, and post-approval changes, ensuring FDA, EMA, and ICH compliance. Act as SME for inspections and audits. Implement QbD principles.
- Develop and oversee drug product manufacturing budgets, aligning cost efficiency with operational excellence.
- Champion continuous improvement initiatives to enhance efficiency, reduce costs, and improve process robustness.
- Collaborate cross-functionally to align operational execution with business objectives and organizational goals.
QUALIFICATIONS
- Ph.D., M.S., or B.S. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field.
- 10+ years of experience in drug product formulation and process development, and manufacturing within the pharmaceutical or biopharmaceutical industry.
- Expertise in oral solid dosage forms, including tablets, capsules and products for oral suspension (PfOS).
- Demonstrated success in technology transfer, process validation, and commercial launch of drug products.
- Deep knowledge of GMP manufacturing, regulatory compliance (FDA, EMA, ICH), and Quality by Design (QbD) principles.
- Proven experience in managing CMOs/CDMOs and global supply chains.
- Strong leadership, project management, and problem-solving skills.
- Experience working in fast-paced, dynamic small company environments.
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 $200,000 - $220,000. 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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
$200,000 - $220,000
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Remote
Location
USA
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|
Job Type
unspecified
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Posted
Mar 21, 2025
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
