New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
Under the general direction of the Senior Vice President of Preclinical Development (PCD), the Associate Vice President of Bioanalytics leads a team of analytical scientists with extensive expertise in multiple Bioanalytical platforms (including LC/MS, immunoassays, cell cytometry, PCR) to detect and quantitate small molecules, peptides, proteins, vaccines, gene and cell therapies. The team is responsible for developing, qualifying and validating assays and delivering quality bioanalytical data enabling critical decisions for tour company's portfolio at all stages of drug development and commercialization.
+ Provides strategic, scientific, and operational leadership for the Bioanalytical organization located at multiple sites, including sample management, method development and sample analysis, data review and interpretation.
+ Responsible for bioanalysis to support a large and diverse portfolio of small molecule and large molecule regulated nonclinical and clinical studies.
+ Responsible for vaccine bioanalysis in discovery and development, including generation of primary clinical endpoints and championing an $81M modernization capital investment project.
+ Responsible for high quality reports for regulatory submissions (such as INDs or Common Technical Documents) as well as for implementation of a strong quality and compliance program for all bioanalytical work, including compliance with GxP regulations for preclinical safety and clinical studies.
+ Drives continuous innovation and change internally and externally across all modalities and closely collaborates internally with Discovery groups, Safety Assessment, Translational Medicine, CORE, Regulatory Affairs, Clinical Development and Clinical Operations groups to align on strategy and tactics.
+ Leads the Bioanalytics organization to ensure portfolio deliverables are completed in a timely manner delivering high quality and relevant data to impact critical decisions.
+ Ensures analytical method development and analysis with level of rigor and validation appropriate for stage of development ensuring compliance with internal guidelines, SOPs and regulatory guidelines.
+ Ensures proactive planning, including review of relevant documentation and data, to ensure audit readiness in preparation for regulatory authority audits.
+ Responsible for scientific over-sight of outsourced bioanalytical work to CROs in collaboration with the PPDM Operations, Sourcing and Logistics group, Clinical operations group, Quality assurance group, ensuring adherence to quality and compliance standards.
+ Reviews and assures the appropriate content of regulatory documents (including INDs, Common Technical Documents, and labels). Participates in scientific review of in-licensing candidates.
+ Influences and communicates current guidance on scientific and regulatory issues related to bioanalysis, participating in development of policy as appropriate.
+ Continuously evaluates and prioritizes Bioanalytics capabilities to fully support our company's portfolio. Develops business strategy; oversees resource allocation and implementation of priorities; identifies and manages areas with fungible resources. Establishes budget and develops both internal and external sourcing strategies.
+ Drives innovation within Bioanalytics, identifying technologies and instrumentation for implementation of new experimental strategies. Works closely with external groups (vendors, academic and regulatory) to ensure successful development and implementation of new strategies and technologies.
+ Makes presentations on behalf of our company at industry networking events, scientific conferences, regulatory agency interfaces and other venues.
+ Responsible for a budget of $40+ MM.
+ Manages a team of about ~150 professionals, including Directors, Ph.D. and BS/MS level scientists. Responsible for hiring, developing and retention of talent within the discipline.
+ PhD in relevant discipline and 15+ years related experience in pharmaceutical and/or vaccine discovery and development. Highly proficient in Bioanalytical sciences together with an excellent understanding of how bioanalytical data is used in discovery and development
**Required Experience and Skills:**
+ Demonstrated ability to lead, organize, coordinate, and execute on multiple concurrent highly complex projects, building collaborative teams to address the priority needs of our company.
+ Excellent problem-solving capabilities; able to suggest innovative yet, practical solutions for highly complex issues.
+ Strong decision-making skills, weighing advantages, disadvantages, and business impact for rapid decisions.
+ Strong business acumen and ability to translate scientific and technical information to understand business opportunities.
+ Experience with regulatory guidance, audits and submissions/ responses
+ Strong communication skills.
+ Experience in building strong teams and developing talent.
+ Track record of collaborating both internally and externally.
+ Publishes scientific research in leading journals, participates in scientific organizations and meetings, and may serve as a peer reviewer for scientific journals.
+ Innovative and visionary; ability to understand and communicate the “big picture;” strategic and innovative thinker; open to new ideas.
+ Excellent communication skills.
+ Demonstrated people leadership skills, including strong influence skills.
+ High achievement mindset.
+ Ability to interact creatively, collaboratively, and credibly across the corporation and with external organizations.
+ Flexible, agile, and adaptable personality to enhance success in our company's culture.
+ Effective organizational and leadership skills, strong teamwork and delegation.
+ Uncompromising ethics and integrity.
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.
**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.
**New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.**
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Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEOC GINA Supplement?
OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf)
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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
**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.
**Flexible Work Arrangements:**
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**Number of Openings:**
**Requisition ID:** R180501