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Job Description

R3 Senior Scientist, PCD Regulated PK/ADA Bioanalytical Outsourcing, Description:

Our company is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

Employees within the Regulated PK/ADA Bioanalytical Outsourcing group within Preclinical Development (PCD) provide oversight for outsourcing of regulated preclinical and clinical assay method development, qualification/validation, and testing in support of biologics and small-molecule programs. This group is seeking a dynamic and collaborative employee with established scientific experience in large and small molecule bioanalytical assay development and validation as well as general project management skills to provide operational and logistical oversight for bioanalytical outsourcing. Bioanalytical outsourcing oversight will include Pharmacokinetics (PK), Anti-Drug Antibody (ADA), and Neutralizing antibody (NAb) assays. Job responsibilities will support third party lab operational oversight and associated activities including management of assay transfer and validations, maintenance of assay life cycles, study sample analysis contracting, relationship management, meeting organization, and vendor performance to ensure quality, timeliness and compliance of outsourced bioanalytical work.

PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.

Specific Responsibilities include:

• Driving program outsourcing strategy and execution

• Communication of program deliverables and timelines to vendors; setting clear expectations for CRO deliverables and monitoring logistics to ensure timely completion of program deliverables.

• Contract Research Organization (CRO)/vendor relationship management (includes scheduling regular teleconferences and driving agendas)

• Review and execution of proposals

• Ensuring necessary agreements are in place before work initiation and working closely with Research Procurement on proposals, CRO onboarding, etc.

• Serving as operational lead for CRO site visits

• Review/input on study testing protocols, bioanalytical reports, test methods, etc.

• Providing budget forecasting support to Finance lead

• Raising performance or resource concerns to vendor and escalating within our company, if issue remains unresolved.

• Facilitating sample reconciliation and data reconciliation through communication and coordination between testing labs and clinical operations/clinical data management

• Build internal relationships with Subject Matter Experts (SMEs) to guide the science so our company's quality expectations are achieved.

Education Minimum Requirement:  

Bachelor’s degree in chemistry, Biochemistry, Biology, Cell Biology, Immunology, or related field with 4+ years of experience in method development, validation, and sample analysis including LC/MS assays, ligand binding assays, and neutralization assays; or master’s degree with 2+ years of experience as above, or PhD.

*Required Experience and Skills: *

• Experience with regulated LC/MS assays, ligand binding assays, cell-based functional and neutralization assays with knowledge of regulatory agency requirements for operating in a regulated clinical testing environment. 

• Ability to work independently and within a cross-functional team.

• Capability to manage individual components of a project.

• Good technical, communication (oral and written), interpersonal, and teamwork skills.　 

• Self-motivated with a positive attitude and proven performance record.

Preferred Experience and Skills:

• 2+ years of experience working in a regulated assay environment and familiarity with FDA bioanalytical guidance requirements.

• Project Management Experience

• Experience with negotiation of timelines and project demands, and vendor relationship management

Location: West Point, Pennsylvania or Rahway, New Jersey

Travel Requirements: 20%

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.

Residents of Colorado

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

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 Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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.

Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$107,600.00 - $169,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Requisition ID: R228428