Principal Scientist, Analytical R&D
Merck & Co., Inc
Posted Tuesday, April 15, 2025
Posting ID: MERCUSR345474ENUS
Rahway, NJ
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Job Description
Job Description:
The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.
The Principal Scientist, under the direction of the Senior Director of GMP Operations, will prepare the department for an expected increase in workload associated with the testing of an extensive portfolio of pipeline assets. Responsibilities include establishing raw materials testing and release capabilities, managing laboratory expansion projects, overseeing harmonization efforts, and driving operational excellence. This includes setting capacity metrics, monitoring performance metrics, and developing scalable practices to meet future departmental demands. This position is based in Rahway, NJ, and aims to foster a culture that prioritizes quality and scientific rigor.
Our BAR&D GMP Operations team plays a crucial role in enhancing patient health worldwide by validating analytical methods, conducting release and stability testing, supporting raw material release, and providing analytical support for cleaning verification activities related to biologic therapies in clinical development. Through these essential efforts, we ensure the safety and efficacy of therapies that directly benefit patients around the globe.
Responsibilities include, but are not limited to, the following:
Education:
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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
$153,800.00 - $242,200.00
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:
No relocation
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:
04/21/2025
*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:R345474
Job Description:
The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.
The Principal Scientist, under the direction of the Senior Director of GMP Operations, will prepare the department for an expected increase in workload associated with the testing of an extensive portfolio of pipeline assets. Responsibilities include establishing raw materials testing and release capabilities, managing laboratory expansion projects, overseeing harmonization efforts, and driving operational excellence. This includes setting capacity metrics, monitoring performance metrics, and developing scalable practices to meet future departmental demands. This position is based in Rahway, NJ, and aims to foster a culture that prioritizes quality and scientific rigor.
Our BAR&D GMP Operations team plays a crucial role in enhancing patient health worldwide by validating analytical methods, conducting release and stability testing, supporting raw material release, and providing analytical support for cleaning verification activities related to biologic therapies in clinical development. Through these essential efforts, we ensure the safety and efficacy of therapies that directly benefit patients around the globe.
Responsibilities include, but are not limited to, the following:
- Collaborates with the B-AR&D Raw Materials Teams to establish a raw material testing and release program in North America.
- Manages raw material testing and specifications, generates, and reviews test specifications.
- Ensures raw materials are tested and released according to the Quality Management System.
- Responsible for the development and maintenance of the raw material builds in RLIMS.
- Authors and oversees raw material-related testing investigations.
- Collaborates across functions to develop procedures and workflows. Addresses conflicts to achieve mutually acceptable outcomes.
- Business area representative on AR&D capacity and metrics initiatives.
- Forecasts team capacity, tracks performance metrics, and identifies efficiency improvements.
- Formulates a strategic plan for a forward-looking organization by assessing capability and skill deficiencies and implements corrective measures.
- Oversees harmonization initiatives and work packages within the business area to improve team compliance.
- Collaborates with the leadership team to establish departmental goals and performance objectives.
- Represents department in capital projects.
Education:
- PhD in relevant scientific discipline with 8+ years' experience; MS in relevant scientific discipline with 12+ years' experience; BS in relevant scientific discipline with 16+ years' experience
- Demonstrated expertise in ensuring GMP compliance within an analytical laboratory setting.
- Experienced in technical operations, specializing in resource modeling and capacity planning.
- Proficiency in analytical methodologies for biologics, such as SEC, IEX, CE techniques, cell-based potency assays, and/or compendial methods.
- Demonstrated initiative, creativity, and innovative problem solving.
- Proven ability to solve technical problems, author and review scientific reports.
- Ability to achieve complex goals within tight deadlines in a dynamic environment.
- Excellent team player with strong communication skills.
- Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP .
- Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).
- Sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well statistical approaches for data analytics.
- Knowledge of regulatory guidance and quality standards, with experience in authoring and reviewing regulatory submissions and responses, including biologics license application submissions, and engaging with Health Authorities.
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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
$153,800.00 - $242,200.00
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:
No relocation
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:
04/21/2025
*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:R345474
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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