Associate Principal Scientist, Oral Formulation Sciences

Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing, and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting-edge science to transform drug delivery and manufacturing technology to positively impact patients.

About the role

The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will lead the formulation development of new chemical entities as part of a matrix team from initial first-in-human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment.

Responsibilities

• Lead development of new, innovative approaches for product development, generation of experimental designs, execution of experimental plans, and data analysis.
• Drive evaluation of new technologies and lead capability build to deploy them to pipeline assets.
• Collaborate effectively within and across functional areas 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 process chemistry, preformulation, 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 our company’s professional image and competitive advantage through patents, presentations, publications, and professional activities.
• Advance areas such as science and technology development, technical and business strategic improvements, and business process innovations.
• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others.

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 4 years of relevant drug product development experience.
• B.S. or M.S. degree in Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 10 years of relevant industrial experience.

Skills

Required Experience and Skills

• Prior experience leading formulation development (Lead Formulator) activities in matrix team environments to define a robust formulation and manufacturing process.
• Experience with conventional and novel drug product technologies that can be utilized to develop pipeline assets, including hands-on experience to independently operate in a pilot plant as well as an in-depth understanding of the science to train others in the department.
• Proven ability to identify and develop innovative ideas as a scientific contributor.
• Broad knowledge of formulation science and in-depth knowledge in multiple areas, including core understanding of the drug development process.
• Demonstrated ability to independently design, execute, and lead complex experiments and data analysis.
• Track record of working effectively with team members of varied skill sets and backgrounds.
• Strong verbal and written communication skills.

Preferred Experience and Skills

• Prior experience leading development projects at an enterprise level.
• Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor.
• Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology.
• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development and optimization of novel production technologies.
• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, and materials science to solving practical pharmaceutical development problems.
• Breadth of experience in related functional areas, including: Pharmaceutical Operations, Analytical Sciences, and Commercialization.

Pay

The salary range for this role is $142,400.00 - $224,100.00. An employee’s position within the salary range will be based on several 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 https://jobs.merck.com/us/en/compensation-and-benefits.