Principal Scientist, Chemical Engineering R&D

Job Description

Principal Scientist, Chemical Engineering R&D

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual for the Crystallization Lab. Through direct, lab-based contributions and scientific supervision of junior crystallization subject matter experts, the principal scientist collaborates with cross-functional teams to ensure small molecule Active Pharmaceutical Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the field of crystallization, this role offers the unique opportunity to influence API phase selection and isolation procedures employed across the portfolio. The candidate may also have the opportunity to manage crystallization development and/or crystallization manufacturing activities at external suppliers.- The principal scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), participating in risk assessments, and Good Documentation Practices (GDPs).-

In addition to supporting pipeline activities, the principal scientist is expected to support innovative processes and technologies aimed at improving the performance and efficiency of crystallizations to realize desired API physical properties across scales. Serving as an example for scientific excellence, the principal scientist advocates technical growth opportunities through collaboration with internal resources and academic or industrial partners.- In partnership with the Director of Chemicial Engineering R&D and/or the Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of junior engineers.

A high level of innovation, creativity, and self-initiative along with the ability to balance and prioritize activities across multiple projects are expected.- Successful candidates will be required to communicate regularly, clearly, and with confidence as they discuss technical problems, support pilot plant operations, and interface with cross-functional colleagues/customers in drug substance, drug product, and material science. Mentoring chemistry and engineering colleagues to share best practices and guide their development toward efficiently achieved successful outcomes is a central expectation of the role.

Position Qualifications :

Education Minimum Requirement: -The position requires either a BS and/or MS in Chemical/Biochemical Engineering (or comparable) from an accredited college/university plus at least 12 years of relevant work experience in process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with at least 7 years of relevant work experience post PhD defense.

Required Experience and Skills:

• For BS/MS candidates, at least 12 years of relevant work experience post-graduation - OR - for PhD candidates with at least 7 years of relevant work experience post PhD defense, where relevant work experience would include the following:
  
• Experience performing lab-based crystallization development and/or solid-state analysis.
  
• Experience with early-phase crystallization development, including solvent solubility, salt and form screens and phase map generation to develop crystallizations for first GMP deliveries.
  
• Experience with developing crystallizations to control and optimize the purity profile of API and intermediates by applying mechanistic understanding of impurity rejection.
  
• Documented successes of scale-up and technology transfer for small molecule crystallizations, moving from laboratory to pilot plant or production scale through empirical approaches or process modeling.
  
• Experience with crystallization Process Analytical Tools (e.g., FTIR, FBRM, Raman, image analysis), common off-line analytical techniques (e.g., HPLC, GC, SEM, NMR), and data-rich experimentation concepts, practices, and equipment.
  
• Proven track record for scientific excellence that includes scientific publications and external conference presentations, as well as commercialization of crystallization processes.
  
• Technical leadership experience, including examples of mentoring technical staff in the laboratory.
  
• Highly effective communication and collaboration skills.
  
• Good organizational, interpersonal, writing, and time management skills.
  

Preferred Experience and Skills:

• Experience with concepts and application of cGMP and GDP during pharmaceutical development and production, across multiple scales on multiple projects.
  
• Experience with the scale-up of filtration and drying operations with consideration for the impact on API attribute control and phase and chemical stability.
  
• Involvement in academic and/or industrial collaborations focused on the advancement of crystallization methods and technology.
  
• Experience with crystallization procedures and practices beyond traditional small molecules, such as peptides, macrocyclic molecules, and novel modalities.
  

PRD #PRD

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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
$169,700.00 - $267,200.00

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 .

You can apply for this role through (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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Chemical Engineering, Chemical Engineering, Chemical Technology, Clinical Manufacturing, Collaborative Communications, Communication, Creativity, Cross-Functional Teamwork, Crystallizations, Data Analysis, Decision Making, Downstream Processing, Driving Continuous Improvement, GMP Compliance, Manufacturing Scale-Up, Materials Science, Mentorship, Pilot Plant Operations, Process Characterization, Process Control, Process Design, Process Optimization, Process Research, Production Process Development, Reaction Engineering {+ 5 more}

-Preferred Skills:

Job Posting End Date:
09/20/2025
*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: R364864