Job detail for Principal Scientist, Early Development Center of Excellence

Job Description

Position Title: Principal Scientist, Early Development Center of Excellence

Our company's Pharmaceutical Sciences and Device Development (PSDD) 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.

Our Oral Formulation Sciences Early Development Center of Excellence is entrusted with developing and supplying our early development formulations, the team’s scope begins as a drug candidate exits discovery and extends through the creation of a Drug Product working group tasked with initiating Commercial Product Development. By cultivating deep technical expertise and applying in early problem-solving, this center champions execution excellence and builds seamless enterprise collaboration with our partners throughout the enterprise.

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 a team of formulators responsible for the advancement of oral early development formulations. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization.

Primary :

• Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction.
• Manages and mentors technical staff to develop team members and support the execution of pipeline programs.
• Ability to spearhead Due Diligence of potential pipeline assets and drug delivery technologies, including representing PSDD on cross-functional teams to make strategic and technical recommendations to leadership.
• Sets direction and coordinates technology development efforts in emerging drug delivery areas.
• Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets.
• Collaborates effectively within and across functional areas to lead the development of novel drug delivery technologies.
• 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 while also helping to coach others in a collaborative environment.
• Coordinates development activities with chemistry, analytical, and physical groups.
• Leads project activities at external manufacturing sites.
• Facilitates manufacturing, packaging and release of clinical supplies for clinical studies, assists in scale up activities at pilot scale, and summarizes results in technical reports and presentations.
• Enhances 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.
• Builds and maintains awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and develop staff across the organization.

Education Minimum Requirement:

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

Required Experience and Skills:

• Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process.
• Ability to lead complex teams in the development of new molecules and new technologies that shape drug delivery strategy across our company.
• Extensive 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.
• Recognized as a technical expert and 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, excipient attributes, and formulation-process interplay.
• Demonstrated ability to independently design, execute and lead complex experiments and data analysis.
• Track record of working effectively with team-members of diverse skill sets and backgrounds.
• Strong verbal and written communication skills.

Preferred Experience and Skills:

• 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 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.
• Ability to engage others to build a strong scientific community and address drug delivery challenges.
• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems.

We are a research-driven company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Company & Co., Inc., Rahway, New Jersey, USA is known as “Our Company” in the United States, Canada & Puerto Rico. We are known as “Our Company” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we aspire to be the premier research-intensive company.

Required Skills:

Adaptability, Adaptability, Biomedical Engineering, Cell Culture Process Development, Cell Line Development, Chemical Engineering, Combination Products, Data Analysis, Design of Experiments (DOE), Drug Delivery, Drug Formulations, Early Phase Clinical Trials, External Manufacturing, Finite Element Analysis (FEA), Innovative Thinking, Leadership Mentoring, Manufacturing Processes, Manufacturing Strategies, Manufacturing Technologies, Matrix Management, Perform Testing, Pharmaceutical Process Development, Pharmaceutical Process Engineering, Pharmaceutical Sciences, Pilot Projects {+ 10 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills 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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$173,200.00 - $272,600.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/7/2026

*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.