Principal Scientist, Oral Formulation Sciences

About the role

Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing. Scientists design, develop, and scale-up the formulation, device, and manufacturing process to positively impact patients. The successful candidate will lead CMC project teams and the formulation development of new chemical entities through a matrix team from initial first-in-human formulations (suspensions, solutions, capsules, tablets) to final market formulation definition and manufacturing process robustness assessment. This individual will also drive new technology strategy, scientific understanding, and capability builds within the organization.

Responsibilities

• Lead development of new, innovative approaches for product development, including experimental design, execution, and data analysis to impact pipeline development and set strategic direction.
• Mentor technical staff to develop team members scientifically and support the execution of pipeline programs.
• Spearhead due diligence of potential pipeline assets and drug delivery technologies, representing PSCS on cross-functional teams to make strategic and technical recommendations to leadership.
• Set direction and coordinate technology development efforts in emerging drug delivery areas.
• Drive evaluation of new technologies and lead capability builds to deploy them to pipeline assets.
• Collaborate within and across functional areas to lead the development of novel drug delivery technologies.
• Serve as a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology.
• Independently execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities while coaching others in a collaborative environment.
• Coordinate development activities with chemistry, analytical, and physical characterization groups.
• Lead project activities at external manufacturing sites.
• Facilitate manufacturing, packaging, and release of clinical supplies for clinical studies, assist in scale-up activities at pilot and commercial scale, and summarize results in technical reports and presentations.
• Enhance the company’s professional image and competitive advantage through patents, presentations, publications, and professional activities.
• Build and maintain awareness of relevant and emerging technologies to develop institutional understanding and staff across the organization.

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of relevant industry experience.
• M.S. degree in Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 10 years of relevant industrial experience.
• B.S. degree in Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 14 years of relevant industrial experience.

Skills

Required

• Ability to lead formulation development activities in matrix team environments to define a robust formulation and manufacturing process.
• Experience leading complex teams in the development of new molecules and technologies that shape drug delivery strategy.
• Extensive experience with conventional and novel drug product technologies, including hands-on experience in a pilot plant and the ability to train others.
• Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas.
• Broad knowledge of formulation science and in-depth knowledge in multiple areas, including core understanding of the drug development process, excipient attributes, and formulation-process interplay.
• Demonstrated ability to independently design, execute, and lead complex experiments and data analysis.
• Strong verbal and written communication skills.
• Adaptability, Biomedical Engineering, Cell Culture Process Development, Chemical Engineering, Combination Products, Data Analysis, Design of Experiments (DOE), Drug Delivery, Drug Formulations, External Manufacturing, Finite Element Analysis (FEA), Innovative Thinking, Leadership, Mentoring, Life Cycle Planning, Manufacturing Processes, Manufacturing Strategies, Manufacturing Technologies, Matrix Management, Pharmaceutical Process Development, Pharmaceutical Process Engineering, Pharmaceutical Sciences, Pilot Projects.

Preferred

• Prior experience leading development projects at an enterprise level.
• Strong mentoring capabilities to build individuals and teams.
• Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technologies.
• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through novel production technologies.
• Desire to build new capabilities through evaluation of new technologies and hands-on optimization of existing technologies.
• Ability to engage others to build a strong scientific community and address drug delivery challenges.
• Demonstrated ability to apply principles of physical/organic chemistry, physical pharmacy, and materials science to solve practical pharmaceutical development problems.

Pay

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at Merck Compensation and Benefits.