Job Description
The Chemical Commercialization Technology (CCT) department, which is part of our 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 and leadership of internal and external work.
The Principal Scientist, Engineering position leverages scientific/technical experience to lead process development teams to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline. Given the significant role of biocatalysis and enzymes in the portfolio, the ideal candidate should have a specific expertise in microbial fermentation and downstream processing and is expected to draw on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.
The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation and downstream processing laboratory capabilities, in addition to supporting transfer of technologies to commercial manufacturing. The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist 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).
Position Qualifications:
Education Minimum Requirement:
The position requires a BS and/or MS in Chemical Engineering, Bioengineering, Biological Engineering, Synthetic Biology or a related field from an accredited college/university plus at least 11 years of relevant work experience in process development or PhD with at least 7 years of relevant work experience post PhD defense.
Required Experience and Skills:
Relevant work experience in chemical, pharmaceutical, large molecule, or vaccine process development, including the following:
Experience and knowledge in microbial fermentation and downstream process development and optimization, as well as process scale-up and scale-down
Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity
Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory
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:
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
Experience leading file authoring, validation planning and execution
Experience guiding internal/external technical discussions
Familiarity with statistical design and analysis tools
Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting
Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design (QbD) principles.
Experience supporting/writing regulatory filings.
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.
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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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:
$169,700.00 - $267,200.00
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:
04/19/2025
*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.
