Senior Manager, Drug Product Development, CMC

Role Summary

Senior Manager, Drug Product Development, CMC will support Drug Product Development within Technical Operations. The role combines hands-on formulation development expertise with strategic oversight of drug product development programs. It drives the expansion of on-site capabilities, provides in-person leadership of drug product development activities, and leverages formulation design and manufacturing expertise to support early-stage formulation development and late-stage process development for small molecule therapeutics. The role reports to the Director, Drug Product Development and is located on-site in San Diego.

Responsibilities

• Design, plan, and execute formulation development strategy and experiments for new drug candidates, from preclinical through first-in-human Phase 1 (and beyond) based on diverse, cross-functional stakeholder input, including Target Product Profile (TPP).
• Utilize strong scientific fundamentals to develop robust, phase-appropriate formulations with consideration for future technical transfer of scalable manufacturing processes.
• Lead and manage technical transfer of formulation and process to external vendors to reliably deliver clinical trial materials, including in-person support of critical manufacturing activities.
• Interpret and analyze scientific results for presentation and recommendations.
• Author drug product development reports and relevant sections of regulatory submissions.
• Meet the current and future needs of drug product development through in-person operational leadership of formulation labs.
• Develop and implement lab policies, practices, and workflows to support safe, high quality, and efficient lab operations
• Develop and maintain high quality and robust experimental data acquisition and record keeping practices.
• Maintain equipment to ensure safe, optimal performance and enable execution of high-quality drug product development activities in a timely manner.
• Train other personnel in lab safety practices, equipment use and cleaning, and experimental study execution, as needed.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in pharmaceutical sciences, engineering, or related field with at least 8 years of relevant technical experience (an equivalent combination of experience and education may be considered).
• 5 years of supervisory experience.
• Proven hands-on experience leading the development of oral solid dosage and first-in-human formulations rooted in scientific fundamentals.
• Strong mechanical aptitude/knowledge and hands-on experience with common oral solid dosage formulation/process equipment (e.g., blending, granulation, tablet compression, pan coating) and related analytical techniques.
• Hands-on experience with R&D scale spray drying equipment strongly preferred.
• Experience maintaining lab-based equipment and instruments (including coordinating vendor supported maintenance and calibration).
• Prior working experience with laboratory safety assessments such as Hazard and Operability (HAZOP) analysis and Job Safety Analysis (JSA).
• Working knowledge of drug product development characterization techniques for powders and tablets.
• Understanding of analytical chemistry techniques and data interpretation as they relate to the analysis of drug substance and drug product (HPLC, dissolution, differential scanning calorimetry, Karl Fischer, X-ray powder diffraction, scanning electron microscopy).
• Understanding of cGMP requirements and ICH and regulatory guidance, including ability to apply to development programs.
• Excellent writing skills for preparation of operating procedures and technical reports.
• Excellent oral communication skills including the ability to effectively and accurately present data to peers, management, and external partners.
• Demonstrated ability to work in a goal and team-oriented setting and communicate/manage competing priorities.
• Flexibility to operate within a rapidly changing environment with a safety-first mindset and high attention to detail.

Skills

• Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
• Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint), MS Project.

Additional Requirements

• Physical Demands: Laboratory activities require extensive drug product formulation and process lab work; environmental health and safety requirements apply.
• Physical Activities: Sit for long periods; some walking; lifting up to 20 lbs may be required.
• Travel: Travel may be required up to 20% of time to observe or support vendor site activities.