Job Description

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking highly motivated individuals who are looking for an opportunity to work in a fast-paced job that provides a high degree of technical leadership and mentoring. This position leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, robust and productive processes, through scale-up, tech transfer, process characterization, validation and filing. This role involves hands-on process development at the laboratory bench and kilo lab scales, in addition to support of and scale-up to pilot plant and commercial manufacturing scales. The candidate will also provide mentoring and scientific direction to develop junior staff to design, plan, and implement advanced experiments aimed at achieving research goals related to process development, technology development, and production of active pharmaceutical ingredients (API). The candidate may also have the opportunity to manage process 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), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

A high level of innovation, creativity, and self-initiative along with the ability to plan and organize activities are expected. Successful candidates will be required to communicate regularly, clearly, and effectively as they discuss technical problems, support pilot plant operations, and interface with cross-functional colleagues/customers.

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 11 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 6 years of relevant work experience post PhD defense.

Required Experience and Skills:

• For BS/MS candidates, at least 11 years of relevant work experience post-graduation - OR - for PhD candidates with at least 6 years of relevant work experience post PhD defense, where relevant work experience would include the following:

• Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization.

• Demonstrations of successful chemical process scale-up and technology transfer, moving from laboratory to pilot plant or production scale.

• Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity.

• Ability to mentor technical staff in the laboratory and through data analysis.

• Highly effective communication and collaboration skills.

• Good organizational, interpersonal, writing, and time management skills.

• Lead and operate within a cross-functional process development team.

Preferred Experience and Skills:

• Direct experience with pharmaceutical drug development

• Knowledge of concepts and application of ICH, cGMP and GDP during pharmaceutical drug substance development and production.

• Experience with enabling technologies in chemical processing, such as bio/chemo-catalysis, continuous processing, and/or particle engineering.

• Experience applying statistical experimental design (i.e. Design of Experiments), data-rich experimentation, process modeling, and data analysis

• Experience with chemical engineering-related technology development

• Experience with risk assessments, process characterization, validation, and regulatory authoring.

• Proven track record of technical innovation and sharing of this work internally and externally via publications and conference presentations.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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.

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Requisition ID:R310769