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 crystallization subject matter expert. The incumbent will develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our diverse 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. Under scientific direction, 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 may 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 of 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 5 years of relevant work experience in crystallization process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university.

Required Experience and Skills:

• Hands-on laboratory experience (> 2 years, inclusive of time in academia) performing chemical process development, including crystallization process development and/or solid state analysis

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

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

• Highly effective communication and collaboration skills

Preferred Experience and Skills:

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

• 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)

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

• Understanding of pharmaceutical drug substance processing

• 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

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

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Requisition ID:R342535