Associate Principal Scientist, Oral Formulation Sciences

Merck; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck in Rahway, NJ, is seeking an Associate Principal Scientist to lead formulation development of new chemical entities from early stages through manufacturing process robustness. The role operates within a matrix team, coordinating with process chemistry, preformulation, analytical and characterization groups to drive scalable, compliant drug product solutions.

The successful candidate will guide DOE-driven experiments, mentor peers, and contribute to technology deployment, patents, and

Qualifications

• Ph.D. with 4+ years of drug product development experience.
• BS/MS with 10+ years of relevant industrial experience.

Responsibilities

• Lead development of innovative approaches and DOE plans for product development.
• Evaluate new technologies and build capabilities for pipeline assets.
• Collaborate across functional areas as SME in drug delivery or manufacturing.
• Independently execute formulation and process development activities.
• Coordinate development activities with process chemistry, preformulation, analytical groups.
• Lead external manufacturing site activities and summarize results.

Skills

DOE

Drug Delivery

Pharmaceutical Formulations

Manufacturing Processes

Project Leadership

Education

Ph.D. in Chemical/Biomedical/Pharmaceutical Sciences

B.S./M.S. in Engineering or Pharmaceutical Sciences

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 Process Development, Drug Delivery, Drug Delivery Technology, Drug Development, Experimental Methods, Expression Vectors, External Manufacturing, Interpersonal Relationships, Leading Project Teams, Life Cycle Planning, Manufacturing Processes, Manufacturing Strategies, Manufacturing Technologies, Molecular Biology, Perform Testing, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Process Engineering, Pharmaceutical Research, Physical Characterization {+ 6 more}

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Equal Employment Opportunity Provider

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, tools and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.

We offer a comprehensive package of benefits. Available benefits include 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.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R412812