Director, Drug Product and Process Development

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

📋 Description

• Oversee the strategic and technical dimensions of solid oral dosage formulations produced at contract development and manufacturing organizations (CDMOs)

• Direct the development of formulations, processes, scale-up, process validation, process performance qualification, and technology transfer

• Provide ongoing support for GMP production of pharmaceutical products at external CDMOs

• Build and sustain business and technical partnerships with CDMOs and internal teams

• Lead the design, development, and transfer of manufacturing processes

• Manage the CMC drug development process from the preclinical phase through clinical stages

• Ensure project teams adhere to GMP, US and international regulatory standards, and industry best practices

• Mentor and lead scientists, researchers, and engineers

• Propel formulation development, process optimization, scale-up, and technology transfer initiatives

• Promote continuous improvement efforts and implement industry best practices

• Collaborate with quality assurance and regulatory teams to facilitate technology transfer, scale-up, and commercialization

• Guide team members while maintaining expertise in production equipment and dosage form manufacturing

• Author, review, and approve development plans, protocols, reports, and regulatory submissions

• Report directly to the Executive Director of CMC & Product Development

⛳️ Requirements

• Bachelor's or Master's degree in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or a related field with at least 15 years of experience in the biopharmaceutical sector

• Doctorate in Pharmaceutics, Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or a related field with over 10 years of experience in drug product development within the biopharmaceutical industry

• Proven experience in leading and managing CMC pharmaceutical development teams

• Demonstrated ability to drive the development and commercialization of pharmaceutical products

• Capacity to prioritize and manage multiple projects at once

• Competence in meeting deadlines and adapting to shifting priorities in a fast-paced environment

• Strong leadership, communication, and interpersonal skills

• Ability to influence and collaborate effectively with both internal and external stakeholders

• Excellent analytical and problem-solving skills

• Capability to make informed decisions based on scientific, technical, and business factors

• Understanding of project budget management

• Experience in managing pharmaceutics and development of immediate- and modified-release formulations for solid oral dosage forms or immediate- and extended-release parenterals, including injectables, infusions, implants, and long-acting injectables

• Familiarity with product lifecycle management and process analytics

• Expertise in cutting-edge production equipment and dosage form development

• Knowledge of GMP and US and global regulatory requirements, including FDA, ICH, EMEA, and WHO

• Willingness to travel 10–40%

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage

• Basic life insurance provided by the company

• Accidental death and dismemberment insurance

• Short-term and long-term disability insurance

• Tuition reimbursement program

• Assistance with student loans

• Generous 401(k) matching contributions

• Flexible time off policy

• Paid holidays

• Paid leave programs

• Additional company-provided benefits

• Opportunity for incentives