Summary, Focus and Purpose

The Chemical Commercialization Technology (CCT) department, which is part of the Manufacturing Division, is seeking self-motivated individuals who are looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility, mentoring, and leadership of internal and external work. This Senior Scientist, Engineering position leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API) characterization projects, (ii) mentor junior staff within the CCT organization, and (iii) lead or support internal and external development with line of sight to robust supply, pre-validation, and validation for a selection of portfolio projects and provide supply support. As the early-stage Research & Development Division led portfolio progresses to late-stage projects, the incumbent is expected to help transition characterization work execution/management to CCT ownership.

The incumbent is expected to quickly develop and provide scientific expertise in small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) /Quality by Design (QbD) methodologies and tools around the statistical design of experiments (DOE) and analysis of experiments (ANOVA, PCA, RSM, Design Expert, Minitab, JMP). Face-to-face mentoring is expected within laboratories at the Rahway, NJ site to develop junior staff. The role requires participation in one or more cross-divisional API-WGs and the incumbent will help influence the API-WG's direction on Manufacturing Division specific needs. The role also involves collaboration (largely remotely) with external suppliers while managing process development and validation activities. Travel is expected ranging from 10 - 20% of the time. Normal travel per campaign might include a kickoff trip and a separate multi-week period of on-site coverage, typically 1-3 times per year depending on project complexity. Support of Research & Development Division led filing work, early development work, and/or piloting activities is also likely in the course of commercializing new processes.

Education

• Bachelor of Science with six years relevant work experience or Master of Science with three years relevant work experience or PhD in Chemical Engineering or Chemistry from an accredited college/university

Experience | Skills | Requirements

Required

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Superior understanding of chemical engineering fundamental concepts
• Principled verbal and written communications
• Experience with process scale-up and technology transfer, moving from the laboratory to pilot plant or factory scale
• Motivation to conduct both laboratory experimentation and on-site support of scale-up activities and manufacturing operations
• Ability to work in the laboratories at the Rahway, New Jersey site with occasional domestic and international travel,
• Excellent organizational, interpersonal, writing, and time management skills

Preferred

• Relevant work experience in process development in any modality (e.g. small molecules, large molecules, vaccines, drug substance or drug product, etc.) or chemical development in a related industry, ideally with experience conducting one or more programs of statistically-designed experimentation
• Experience with developing and executing an experimental program to optimize and de-risk the scale-up of microbial fermentations and associated downstream processing
• Experience interfacing and influencing relationships with internal and external partners to drive process development, scale-up, and technology transfer
• Experience executing an experimental program or statistical data analysis to address issues of process design, robustness, or productivity for an existing product/process
• Familiarity with QRM/QbD methodologies and tools around statistical design and analysis
• Familiarity with the concepts and application of Good Laboratory Practices (GLP's)/current Good Manufacturing Practices (cGMP's) ideally during Pharmaceutical drug substance/drug product development and production, e.g. in a pilot and/or factory setting

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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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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:
$111,400.00 - $175,300.00

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:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/17/2025
*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:R327397