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Principal Scientist, Analytical Research and Development

4 months ago

Arvada, Colorado, United States Merck Full time

Job Description

Our Scientists are our Inventors. We deliver robust scientific data and interpretation that drives the commercialization of breakthrough therapeutics using innovative thinking, state-of-the-art facilities, and modern equipment. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing your career.

The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a motivated Principal Scientist with technical expertise in developing large molecule potency assays. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of multi-valent recombinant vaccine products. The Vaccine Potency team is a laboratory-based scientific and technical group tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Vaccine clinical candidates.

The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. They will be accountable to inspire and sponsor scientific evaluation and implementation of innovative and disruptive technologies and approaches. Responsibilities include representing the group on product development teams and defining the potency strategy for a portion of our large molecule portfolio, oversight of method development and testing, and scientific mentoring. The candidate will be expected to effectively communicate with stakeholders in partner organization and to management and governance teams.

Education Requirements:

  • Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of 8 years of relevant experience
  • OR M.S. with a minimum of 10 years of relevant experience
  • OR Bachelor's with a minimum of 14 years of relevant experience

Required Skills and Experience:

  • In-depth knowledge and understanding of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, and multiplexing.
  • Expertise in cell biology and immunology, with application to solve complex scientific challenges related to designing and developing GxP potency assays to support a variety of vaccine modalities.
  • Demonstrated ability to lead complex experimental design and detailed data analysis concepts related to analytical method development.
  • Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.
  • Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.
  • External scientific engagement demonstrated through publications, regulatory guidance documents, industry white paper contributions, presentations at scientific meetings, and/or membership on (or leading) cross-company working groups or consortia.
  • Excellent verbal and written communications skills.

#AR&D

#EligibleforERP

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.

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.

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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, 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 "remote".

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/30/2024

*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.

Job Posting End Date:06/30/2024

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:R295603