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Merck & Co, Inc

Executive Director, Immunogenicity and Molecular

Executive

Executive Director

No

West Point, Pennsylvania, United States

Job Description

Our Development team ensures production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.

The Executive Director, Immunogenicity and Molecular guides the Preclinical Development (PCD) Immunogenicity and Molecular Biology Bioanalytics group with overall responsibility for method development, validation, and implementation of immunogenicity/ molecular biological assays as primary endpoint and/or safety assays for Vaccines and cell-based Biologics development, including preclinical safety, clinical studies and post-marketing studies.

Responsible for conducting bioanalytical work to a high level of quality and rigor, ensuring compliance with regulatory guidance, and for preparation of high-quality regulatory submissions. Provides strategic direction and leadership for staff, builds strong teams, attracts and develops diverse staff. Provides technical oversight of external development and implementation of regulated immunogenicity and molecular biology assays.

Education:

  • Ph.D., in Biochemistry, Molecular Biology, Microbiology, Analytical Chemistry or a related discipline with minimum of 15 years of bioanalytical or related experience, including Bioanalytical assay development and/or application of bioanalytical assays for clinical testing, in drug and/or vaccine development; an M.S Degree would need to demonstrate commensurate accomplishments.

Required Experience and Skills:

  • Demonstrated expertise in immunogenicity, molecular biology, method development, clinical assays, and analysis of biologics and vaccines is very desirable together with excellent knowledge of how this information is used in preclinical, clinical development and post-licensing studies including concomitant testing/ combination studies.

  • Experience in interactions with regulatory agencies is required with demonstration of successful bioanalytical strategies.

  • Demonstrated leadership and management experience in the area of regulated bioanalytics.

  • A track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations

  • Ability to set and deliver on current and future strategies

Preferred Experience and Skills:

  • Direct project support and an understanding of how immunogenicity data impact critical decisions. Someone with a background in robotics, laboratory information management systems, and information technology, is also desired.

  • Demonstrated ability to improve end-to-end lean streamlined processes is beneficial.

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., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

#EligibleForERP

#pcdbioanalytical

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

Current Employees apply HERE

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US and Puerto Rico Residents Only:

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For more information about personal rights under Equal Employment Opportunity, visit:

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

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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/International

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R206355