Associate Director – Drug Product Development

This is a fully remote position, open to applicants in United States.

📋 Description

• The Associate Director of Drug Product Development plays a crucial role in planning and executing the comprehensive drug product (DP) development strategy from clinical development to commercialization for multi-component biologic drug products, which include monoclonal antibodies (mAbs) and synthetic oligonucleotides.

• This position offers technical expertise and operational oversight for formulation development, characterization of formulation and process robustness, GMP manufacturing, process and product characterization, process validation, and commercial readiness, while collaborating closely with external CDMOs.

• The Associate Director is accountable for planning, supervising, and supporting drug product development activities throughout the product lifecycle, as well as overseeing outsourced development and manufacturing operations in a virtual environment.

• This role guarantees the high-quality execution of tasks, adherence to project timelines, and compliance with regulatory and quality standards across formulation development, process optimization, robustness characterization, GMP production, technology transfer, process characterization, process validation, and commercial manufacturing.

• Familiarity with Design of Experiments (DoE), Quality by Design (QbD), and risk-based process development methodologies is highly advantageous.

• This position necessitates close collaboration with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other cross-functional teams to propel therapeutic candidates from development through to commercialization.

⛳️ Requirements

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, or a related scientific field with at least 5 years of relevant biopharmaceutical industry experience; or an M.S. in a related field with a minimum of 10 years of relevant biopharmaceutical industry experience.

• Proven experience in biologic drug product development, showcasing expertise in formulation development, formulation robustness characterization, process development, technology transfer, and GMP manufacturing.

• Experience with monoclonal antibodies is strongly preferred; familiarity with oligonucleotide therapeutics is highly desirable.

• Extensive knowledge of formulation development for both liquid and lyophilized injectable products, including formulation optimization, stability assessment, manufacturability, and management of the commercial product lifecycle.

• Strong grasp of drug product process development, scale-up, process characterization, process validation, continued process verification (CPV), aseptic fill/finish manufacturing, and readiness for commercial manufacturing.

• Broad understanding of Chemistry, Manufacturing and Controls (CMC), encompassing drug substance and drug product development, analytical development, quality systems, regulatory requirements, and manufacturing technologies.

• Familiarity with combination products, prefilled syringes, autoinjectors, and other injectable drug delivery systems is preferred.

• In-depth knowledge of cGMP, GLP, ICH guidelines, FDA regulations, and other relevant global regulatory requirements.

• Documented experience in authoring and supporting CMC documentation for regulatory submissions, including INDs, BLAs, IMPDs, and/or MAAs.

• Proven ability to manage external development and manufacturing partners, including CDMOs, CROs, and technical consultants, in a virtual development environment.

• Demonstrated technical expertise in employing Quality by Design (QbD), risk management, and Design of Experiments (DoE) principles in drug product development.

• Experience in oncology, immuno-oncology, and/or combination drug-device products is preferred.

• Strong scientific and technical expertise in biologic drug product formulation development, process development, manufacturing, and CMC development.

• Excellent verbal, written, presentation, technical writing, editing, and scientific communication skills.

• Demonstrated capacity to collaborate effectively with cross-functional teams and external partners, including Drug Substance Development, Analytical Development, Manufacturing, Quality Assurance, Regulatory Affairs, and CDMOs.

• Strong analytical and problem-solving abilities, with the capacity to independently evaluate complex technical challenges and formulate practical, science-based solutions.

• Proven capability to provide technical oversight and scientific guidance to external development and manufacturing partners within a virtual development environment.

• Self-motivated, detail-oriented, and adept at working efficiently in a fast-paced, collaborative, and matrixed environment.

• Knowledgeable in Quality by Design (QbD), risk-based development, Design of Experiments (DoE), and applicable ICH, FDA, and global regulatory expectations for biologic drug products.

• Familiarity with the competitive landscape, emerging technologies, and regulatory trends in biologics and immuno-oncology drug development is advantageous.

• Proficiency in both English and Mandarin is highly desirable.

• Willingness to travel domestically and internationally as required by business needs.

• Flexibility to work varied hours, including early morning and late evening/night meetings, to effectively collaborate with global teams, CDMOs, and CROs.

🏝️ Benefits

• This position typically qualifies for cash incentive compensation.

• Equity incentive compensation is also part of the package.

• Employees are entitled to benefits under the Company’s benefit plans.