Principal Scientist, Technical Director - Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.  This team ensures right-first-time manufacture and delivery of high quality non-sterile drug products (spray-dried intermediates, tablets and capsules), leveraging unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company's research division, focusing on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology, to enable faster delivery of new medicines to clinical trials.

The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for a Principal Scientist / Sr. Principal Scientist / Technical Director – Process Engineering to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our Company's pipeline.

The successful candidate will be a passionate engineer with strong academic fundamentals and a drive to develop and improve processes focusing on robustness to ensure the highest product quality. This individual will also be responsible for driving new technology strategy, scientific understanding and capability build within the organization.

This person will:

• Own FLEx interactions across CMC project teams, and especially the manufacturability assessment of first in human formulations (suspensions, solutions, capsules, tablets) to final market formulation, defining scaling and control strategies in partnership with Oral Formulation Sciences and Pharmaceutical Commercialization Technologies, among other teams.

• Lead development of new, innovative approaches for product and process development, generation of experimental designs, and data analysis to impact pipeline development and set strategic direction.

• Mentor a team of process engineers to develop team members scientifically and support the execution of pipeline programs.

• Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.

• Bring knowledge and creativity to the position as well as having the discipline to drive results

• Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.

• Coordinate development and manufacturing activities with Oral Formulation Sciences, chemistry, analytical, and physical characterization groups

• Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.

• 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

• Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.

Required Experience and Skills:

• Extensive knowledge, experience and proven expertise in GMP drug product processing, particularly in solid oral dosage forms, leading on-the-floor activities, process robustness & validation, root cause analysis, change control, and deviation management.

• Recognized as a subject matter expert and scientific contributor in multiple drug deliveries and/or manufacturing technologies

• Established record of high-impact contributions and/or interactions with publications, advisory seats, industry-university consortia participation, or others.

• Proven track record in operating in a fast-paced manufacturing environment to resolve technical issues while meeting customer needs in a compliant manner.

• Demonstrated capability in leading and coaching others with strong coordination, communication, and supervision on all technical issues.

• Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.

• Experience supporting GMP audits, responding to observations, and owning CAPAs that comprehensively address opportunity areas

• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, engineering, and materials science to solve practical pharmaceutical problems

• Breadth and depth of experience in related functional areas, including: Formulation, Analytical Sciences, and Commercialization.

• Ability to lead process development activities in matrix team environments to define a robust manufacturing process for traditional and/or unconventional formulations.

• 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.

Education Minimum Requirements:

Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum of 14 years relevant experience, or a Master’s degree with 10 years of relevant experience, or a PhD degree with 8 years of relevant experience.

Preferred Experience and Skills:

• Extensive hands-on experience with conventional and novel drug product technologies that can be utilized to develop pipeline assets, including in-depth understanding of the scientific principles behind them.  

• Has 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 understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and commercial marketing, balancing the needs of patients and ensuring successful launch of drug products

• Experience leading development projects at an enterprise level

• Strong mentoring capabilities to build individuals and teams.

Schedule:

This role supports operational coverage across multiple shifts. Candidates must be willing and able to float between 1st and 2nd shift.

Work schedules for this role will vary based on the needs and timing of assigned campaigns. While standard working hours will apply most of the time, there may be occasions when you are required to work earlier, later, or extended hours to support campaign requirements. Reasonable notice of schedule changes will be provided whenever possible.

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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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

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. 

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