Senior Scientist, Bioanalytical Regulated Immunogenicity and Molecular

3 weeks ago

Gwynedd Valley, Pennsylvania, United States Merck Full time

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

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'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We are seeking a highly motivated Senior Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Bioanalytical Regulated Immunogenicity and Molecular. Our team is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis, and visualization, and automated liquid handling. The successful candidate will design, develop, and support bioanalytical vaccine immunogenicity assays to support regulated preclinical and clinical vaccine development. The individual will be responsible to contribute with limited supervision to all hands-on laboratory aspects of bioanalytical assay development, qualification/validation, technology transfer, and/or troubleshooting. The candidate will understand and leverage automation technologies across assay development, support, and data analysis. A strong, solution-focused scientific background is critical. Preferably, the successful candidate should have a proven track record for developing assays capable to meet regulatory expectations for validation and line of sight for life-cycle maintenance. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes to increase throughput and reduce turn-around times. Providing expert technical representation on multidisciplinary teams will be expected.

Responsibilities

  • Leverage a strong scientific background to design, develop, and support ligand binding assays such as Luminex, Mesoscale, ELISA and/or cell-based functional immunogenicity assays.
  • Responsible for the execution of method development, qualification/validation, troubleshooting and/or pre-clinical/clinical sample analysis as needed.
  • Operation, understanding, and utilization of automated equipment.
  • Contribute to the assessment and implementation of new analytical technologies with a focus on problem-solving.
  • Understand and adhere to regulated frameworks and guidances in collaboration with team leads and Quality Assurance.
  • Serve as an internal subject matter expert on scientific background and laboratory aspects of bioanalytical development.
  • Holistically, systematically, and efficiently analyze data, determine trends, and communicate to teams and leadership.
  • Strong understanding of systematic scientific concepts and interest in associated laboratory experimentation.
  • Comply with applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address QA findings and observations.
  • Adherence to basic safety procedures in a BSL2 laboratory.

Qualifications:

Minimum education required:

  • PhD in Biological Sciences or related area with 0+ years (with expected completion no later than December 2024), or a MS degree with 4+ years, or a BS degree with 7+ years

Required experience and skills:

  • Knowledge and expertise in assay qualification/validation and troubleshooting of ligand binding immunogenicity assays based on technologies such as Luminex, Mesoscale, or ELISA, and/or experience with in vitro cell-based functional immunogenicity assays such as virus neutralization assays or plaque assays.
  • Critical scientific thinking and systematic trouble-shooting skills.
  • Good verbal and written communication skills to explain and communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams.
  • Ability to follow procedures and regulations, and thorough, detail-oriented documentation.
  • Familiarity with liquid handlers and other automation platforms such as Biomek, Hamilton, or Tecan liquid handlers for sample preparation and assay process is preferred.
  • Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) and regulations as pertain to bioanalysis are strongly desired.

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.

#EBRG #vetjobs #DPTM

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 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.

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:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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'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, 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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

BSL-2

Job Posting End Date:

09/5/2024

*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:09/05/2024

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:R308962

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