Job Description

Job Description

Provide analytical support for large and small molecule drugs developed at our company. Develop, validate and transfer analytical methods for drug product characterization, process and scale-up development, in support of product expiry and routine release of clinical and commercial products. Apply advanced analytical techniques such as High-resolution Mass Spectrometry (MS), High or Ultra- Performance Liquid Chromatography (HPLC/UPLC), Ultravioletvisible spectroscopy (UV-Vis) in product development. Optimize existing or develop novel analytical methods to better support characterization and development of therapeutic biomolecule drugs, and tackle scientific challenges related to biotherapeutic drug product stability and robustness. Perform structure elucidation of impurities and degradation products using High-resolution MS to support small and large molecule drug product development. Develop novel biophysical characterization methods based on High-resolution MS platforms to study interactions and higher order structures of therapeutic biomolecules such as proteins, peptides and oligonucleotide with formulation excipients. Author filing documents for drug product in support of investigational and new drug product applications to FDA and health authorities world-wide. Provide the scientific background in responses to questions from FDA and health authorities world-wide regarding analytical methods and characterization of new drug products in investigational and new drug product applications. Work closely with multi-functional project teams and collaborate with different company divisions such as safety assessment and regulatory affairs to assess impact of impurities and degradation products on potential patient safety risk and develop risk mitigation strategies.

Education:

* Must have a Ph.D. in Analytical Chemistry, Chemistry or Biochemistry.

Skills required:

* High-resolution MS platforms (such as Q-TOF, Orbitrap, FT-ICR) and their applications in biophysical/biochemical characterization of biomolecular interactions and higher order structures; modern analytical techniques such as High- or Ultra- Performance Liquid Chromatography (HPLC/UPLC), Ultravioletvisible spectroscopy (UV-Vis).

* Proficient in MS related software such as MassLynx, Xcalibur.

* Proficiency with molecular modeling and molecular dynamics simulations also required. Publications in peer-reviewed Chemistry/Mass Spectrometry journals are desirable.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R102856