Associate Principal Scientist, Oral Formulation Sciences

Merck; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

Merck seeks an Associate Principal Scientist to lead formulation development from discovery through manufacturing readiness. You will guide first-in-human formulations and scale-up, design experiments, and drive process robustness.

This role requires leadership in a matrix environment and deep knowledge of drug delivery technologies. You will collaborate with chemistry, analytics, and manufacturing teams to define pipelines, mentor colleagues, and contribute to clinical study support, patents,

Qualifications

• Led formulation development in a matrix team to define robust formulations.
• Experience with conventional and novel drug product technologies.
• Ability to train others in formulation science.
• Broad knowledge across drug development and core sciences.
• Proven design of experiments and data analysis capability.

Responsibilities

• Lead development of new, innovative approaches for product development and experimental designs.
• Drive evaluation of new technologies and build capability to deploy them.
• Collaborate across functions as a subject matter expert in drug delivery/manufacturing tech.
• Independently execute formulation and process development using DOE.
• Coordinate development with process chemistry, preformulation, analytical, and characterization groups.

Skills

DOE

Formulation Development

Drug Delivery

Matrix Team Leadership

Manufacturing Process

Education

PhD in Chemical Engineering

MS/BS in Engineering or related

Job description

Associate Principal Scientist Job Description:

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.

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 be responsible for leading 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.

Primary Responsibilities:

• Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis
• Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets
• Collaborates effectively within and across functional areas and is a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology.
• The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results
• Can independently execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities while also helping to coach others in a collaborative environment
• Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups
• Leads 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 and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

Education Minimum Requirement:

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

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
• Scientific contributor with proven ability to identify and develop innovative ideas
• Has 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 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 & materials science to solving practical pharmaceutical development problems
• Breadth of experience in related functional areas, including: Pharmaceutical Operations, Analytical Sciences, and Commercialization

Required Skills:

Cell Line Development, Cell Line Development, Chemical Engineering, Design of Experiments (DOE), Detail-Oriented, Downstream Proc