Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for a Senior Scientist position at its Kenilworth, New Jersey facility. The Senior Scientist is responsible for implementation, phase-appropriate validation, and troubleshooting of analytical methods for Biologics in a GMP laboratory. Other responsibilities include GMP analytical testing, data analysis, document writing, and data reporting of Biologics products from the manufacturing facilities to ensure the safety, quality, identity, purity, and potency produced by the facility. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Applicants must have effective organizational, multi-tasking, oral/written communications skills, and show scientific leadership.

Qualifications

Education:

Ph.D. in analytical chemistry/biochemistry or related field or M.S. with a minimum of 5 years of experience in the Pharmaceutical Industry including 3-year GMP experience or B.S. with a minimum of 8 years of experience in the Pharmaceutical Industry including 5-year GMP experience.

Required Experience and Skills:

Support execution of Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools.

Validate and implement analytical methods to support release and stability testing of clinical materials.

Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA principals and SOPs.

Troubleshoot and investigate any challenges associated with the GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders.

Perform data entry, data review, and author technical documents such as SOPs, analytical reports, or data summaries.

Strong collaboration with fellow Analytical Research & Development colleagues as well as cross-functional partners such as Quality, DS and DP groups.

Support compliance audit, inspection activities, and investigation/CAPAs.

Coordinate with Supervisor in scheduling activities to meet deadline. Support training of analytical techniques.

Hands-on experience in GMP operations, UPLC/HPLC analysis of biologics (e.g., SEC, RP, IEX) and CE techniques or molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis) techniques.

Preferred Experience and Skills:

Experience with LIMS, Empower, electronic notebook, data science, LCMS

Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines.

Experience with a QC laboratory startup such as establishing a quality system, sample management, and creating SOP is a plus.

Experience in working in a GMP lab with large molecules is preferred.

NOTICE FOR INTERNAL APPLICANTS

In accordance with 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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

#AR&D

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply

Current Contingent Workers apply

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 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:

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\xe2\x80\x99s thinking and approach problems collectively.

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, generally Tuesday, Wednesday and either Monday or 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 \xe2\x80\x9cremote\xe2\x80\x9d.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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\xe2\x80\x99s relevant skills, experience, and education.

Expected salary range: $107,600.00 - $169,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed .

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

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Merck & Co.