Campus Pride Jobs

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Director to lead the Serology Lab within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

The successful Serology Director candidate will drive the science and operations within the Serology Lab team. As the facility and teams are all new, the Serology Director will first recruit and assemble the Serology team and validate assays on new end-to-end integrated robotics platforms. As a member of the Late Development Vaccines bioanalytical leadership team, they will partner with other leaders to create site processes. Leadership responsibilities will include coaching and mentorship of all Serology team scientists, guiding and improving efficient phase III testing, troubleshooting assay challenges, and supporting any related regulatory questions or inspections of the Serology lab or data.   The Serology Director will also be responsible for developing business plans for the Serology Lab team, including financial, operational, and organizational priorities.

Education Minimum Requirement

• B.A./B.S. in Molecular Biology, Immunology, Cell Biology, Biology, or Biochemistry or a related Biological Sciences discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience

Responsibilities

• Provides leadership to managers and individual contributors on Serology Lab team

• Leverages deep scientific expertise with clinical bioanalytical serology assays to optimize and validate methods using integrated robotic platforms

• Oversees phase III serology assay testing across several studies and/or vaccine candidates and reviews and approves data as needed

• Resolves complex technical, operational, and financial problems

• Applies business and management expertise to set and achieve financial and operational objectives for the Serology Lab

• Influences others internally and externally, including senior leaders, internal customers, and external partners

• Develops relationships with key stakeholders, including robotics, IT, quality, and other partnering organizations to drive improved, quality operations

• Contributes to the development of departmental strategy and represents department on leadership and development teams

• Develops priorities and objectives for the Serology Lab and AdVAnce team to align with division scorecard

• Represents the Serology Lab for internal and external audits

• Promotes our company’s scientific excellence and regulatory influence through leadership in the scientific community

Required Experience & Skills

• Expertise in various assays formats, including but not limited to immunology assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on our company's and/or Luminex platforms or in vitro primary immune cell functional assays such as ELISpot or multi-color flow cytometry

• Ability to lead, mentor, and inspire scientists at various levels; encourages curiosity in others and challenges the status quo to foster innovation

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

• Experience in Agency inspections/audits  

• Experience with regulatory submissions

• Experience working within a GLP, GMP, or other GxP laboratory

Preferred Experience & Skills

• Project management skills

• Established scientific reputation supported by publications and/or external presentations

• Experience working in a GLP bioanalytical laboratory

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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:

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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.

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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”.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/21/2024

*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: R326605