Job Description

Our compo 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 in the Vaccines Outsourcing group within the Department of Pharmacokinetics, Dynamics, Metabolism & Bioanalytics (PDMB) provide oversight for outsourcing of regulated preclinical and clinical assay method development, qualification/validation, and testing in support of vaccines programs. This group is seeking a dynamic and collaborative employee who is detail-oriented with established scientific experience in bioanalytical assay development and validation, as well as general project management skills to provide operational and logistical oversight for bioanalytical outsourcing. Oversight will include supporting a global network of PBMC processing laboratories, critical reagent outsourcing operational management, and outsourcing oversight for ligand binding, functional, and molecular assays for safety and efficacy measurement in support of vaccine programs. Job responsibilities will support third party lab operational oversight activities including contracting, relationship management, meeting organization, and vendor performance to ensure quality, timeliness and compliance for outsourced bioanalytical work.

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

Specific Responsibilities include:

• Supporting oversight responsibilities for a global network of PBMC processing laboratories, including contracting, technical oversight, lab training, qualification, review of technical documents, and trouble-shooting technical issues.

• Driving program outsourcing execution through strategic planning and decision making

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

• Contract Research Organization (CRO)/vendor relationship management (includes scheduling regular teleconferences and driving agendas), leveraging emotional intelligence and influence to build strong partnerships

• Demonstrating proactive execution excellence, ownership and accountability in managing outsourcing activities (review and execution of proposals, CRO onboarding and oversight, data review and testing execution)

• Ensuring necessary agreements, POs, etc. are in place before work initiation and working closely with Research Procurement on proposals, CRO onboarding process, 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 performance issue remains unresolved

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

• Networking and partnership building with Subject Matter Experts (SMEs) to guide the science so our company's quality expectations are achieved.

Education Minimum Requirement:

• Bachelor’s degree in Biology, Cell Biology, Immunology, Biochemistry or related field with 4 years of experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays, and specializing in vaccines method development and validation, or Master’s degree with 2+ years of experience as above, or PhD

Required Experience and Skills:

• Experience in Bioanalytical development and validation, and/or quality control (QC) 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.

Experience with vaccine research, including at least one of the following techniques:

• Cell-based neutralization assays

• Ligand binding assays

• PCR/RT-PCR (traditional and real-time)

Preferred Experience and Skills:

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

• PBMC isolation experience to facilitate lab training/qualification and technical oversight

• Project Management Experience

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

Location:

• West Point, Pennsylvania or Rahway, New Jersey based

• Travel Requirements: 10%

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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.

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 (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.

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

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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$111,400.00 - $175,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/5/2024

*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.

Requisition ID: R318396