Associate Principal Scientist, Engineering Crystallization Laboratory (Onsite)

Merck; Rahway (NJ); On-site; USD 142,400 - 224,100; Full time

Job summary

Merck is seeking a crystallization subject matter expert to develop isolation processes for APIs across clinical programs. You will apply PAT and process modeling to improve crystallization development and achieve desired solid-state properties, purity, and yield.

The role involves hands-on development, scale-up, and collaboration across drug substance and drug product teams. You will mentor colleagues, drive safe and compliant work practices, and contribute to cGMP documentation and risk

Qualifications

• BS/MS candidates: 8+ years post-grad crystallization experience or PhD with 3+ years post-PhD.
• Experience applying crystallization theory and design (supersaturation control, morphology, particle size)
• Hands-on lab experience in chemical process development including crystallization and solid-state analysis
• Experience with process scale-up and technology transfer from lab to production
• Understanding of pharmaceutical drug substance processing and PAT tools

Responsibilities

• Develop isolation processes to deliver solid-state properties, purity and yield for clinical programs.
• Develop technologies to improve crystallization development efficiency and gain mechanistic understanding for rational design.
• Perform hands-on process development and scale-up across benchtop to manufacturing sites.
• Mentor colleagues and collaborate across cross-functional teams on API form and attributes.

Skills

Crystallization

Scale-up

PAT

FBRM

Raman

FTIR

GMP

Cross-functional

Documentation

Education

BS/MS in Chemical/Biochemical Engineering

PhD in Chemical/Biochemical Engineering

Job description

Job Description

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual to serve as a crystallization subject matter expert. The incumbent will develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our different pipeline. This role involves the development of new technologies focused on improving the efficiency of laboratory crystallization development and aims to provide greater process understanding. The application of state‑of‑the‑art tools, including process analytical technology (PAT) and process modeling, will be integral to the position. Developing subject‑matter expertise in drying, milling operations, and particle size control, including execution of wet and dry milling experiments, is expected.

The position involves hands‑on process development and scale‑up work performed at scales spanning benchtop and commercial manufacturing sites. The incumbent will perform independent research which involves conceiving, designing, planning, and implementing advanced studies aimed at achieving mechanistic understanding that informs rational process design for the isolation of Active Pharmaceutical Ingredients (APIs) and drug substance intermediates. The candidate will also have the opportunity to manage crystallization development and/or manufacturing activities at external suppliers. The engineer 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, deviation investigations, and Good Documentation Practices (GDocP). Highly effective communication and collaboration skills are critical to success because the role has broad impact across the organization. Specifically, the role includes considerable cross‑functional collaboration as part of integrated drug substance and drug product teams that collectively drive decisions regarding API form and physical attributes. Mentoring chemistry and engineering colleagues to share best practices and guide development toward 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 8 years of relevant work experience in crystallization process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with at least 3 years of relevant work experience post PhD defense.

Required Experience and Skills

• For BS/MS candidates, at least 8 years of relevant work experience post‑graduation - OR – for PhD candidates with at least 3 years of relevant work experience post PhD defense, where relevant work experience would include the following:


• Application of crystallization theory and design, such as supersaturation control, crystal phase maps, morphology and particle size manipulation, drying, and the associated unit operations.


• Hands‑on laboratory experience (> 5 years, inclusive of time in academia) performing chemical process development, including crystallization process development and/or solid state analysis


• Experience with process scale‑up and/or technology transfer, moving from laboratory to pilot plant or production scale


• Understanding of pharmaceutical drug substance processing


• Experience with crystallization specific Process Analytical Technology (i.e. FTIR, FBRM, Raman, Image analysis)


• The ability to balance cross‑functional work across multiple projects


• Highly effective communication and collaboration skills

Preferred Experience And Skills

• Background with chemical engineering‑related technology development


• Familiarity with kilo‑scale laboratory equipment


• Experience with process modeling (e.g., population balance modeling, distillation modeling)


• Knowledge with milling equipment (spiral jet mills, pin mills, co‑mills, rotor‑stator wet mills)


• Working knowledge of drying technologies and unit operations associated with drug substance manufacturing.


• Experience with organic chemical synthesis and wet chemistry including running experiments, and generating and analyzing data


• Familiarity with drug product processing and experience collaborating across the drug substance/drug product interface


• Familiarity with concepts and application of cGMP during pharmaceutical development and production


• A high level of innovation, creativity, and self‑initiative

Required Skills

Bioprocessing, Chemical Engineering, Chemical Synthesis, Chemical Technology, Cross‑Functional Collaboration, Crystallizations, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Scale‑Up, Pharmaceutical Development, Process Improvements, Protein Purifications, Regulatory Submissions

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.

Requirements

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, 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.

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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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

07/29/2026