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Job Description

Director – Early Development Vaccines

Description

Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and collaboration. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics at Spring House Innovation Park (SHIP) is seeking a Director to join our company and lead a team of approximately 10 scientists to deliver bioanalytical solutions that enable and accelerate vaccine clinical development. The Director will report to the Executive Director of Early Development Vaccines and be part of the leadership team to design and execute a modernization effort to accelerate vaccine development.

The primary role of the successful candidate will be to lead a team to support vaccine early development (Phase 1 and 2) and contribute to drug discovery and development teams within the Infectious Disease and Vaccines therapeutic areas via overseeing a broad portfolio of molecular and cell-mediate based serology assays and collaborating with CROs for assays that are outsourced. The successful candidate will be a scientific leader with a passion for developing assays, delivering high-quality data, and helping teams develop a clinical assay strategy for data-driven decision-making. A record of accomplishment of successful collaboration while working in cross-functional project teams is expected. The successful candidate will also have responsibility for mentoring, scientific supervision, and training scientists to become our future leaders.

Qualifications

Education:

+ A Ph.D. or doctoral level degree in Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related area with 8+ years, a MS degree with 10+ years, or BS degree with 14+ years of relevant experience

Required:

+ 8+ years of experience in molecular biology, immunogenicity and cell-based assay development and optimization.

+ Actively working with staff to encourage and facilitate their personal and scientific development.

+ A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.

+ Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence and curiosity.

+ Setting future strategies and bringing new technologies into the regulated labs.

+ Partner with our Outsourcing team to provide scientific oversight at our Clinical Research Organizations (CROs) to ensure data quality and accuracy is aligned with our company's expectations.

+ Has in-depth understanding of the drug discovery and/or development process and comprehensive knowledge of the principles and concepts of bioanalytical and/or vaccine clinical testing/regulatory filing.

+ Strong technical expertise in bioanalytical assay design, development, and execution in support of antiviral, antibacterial, cell and gene therapy, and/or vaccine discovery. Has advanced knowledge in multiplexed immunogenicity and cell-based assays.

+ Candidate must be trained in GLP and GCLP requirements and must have experience working in a regulated laboratory environment.

+ Proven ability to lead the development of new, innovative bioanalytical techniques including experience in new assay technology evaluation and optimizing these technologies to garner health authority approval.

+ Established external scientific reputation (e.g. publication record, leadership in consortia, external presentations).

Preferred:

+ Experience with immunoassay platforms such as MesoScaleDiscovery, Luminex, ELISA, AphaLISA is a plus

+ Experience in cell-based functional assays to monitor immunogenicity.

+ Familiar with liquid handlers and other automation/robotic platforms for sample preparation and assay process.

+ Working knowledge and proponent of developing a strategy to utilize a standardization process for Data Analysis and strong supporter of using the Design of experts to improve robustness in bioanalytical.

+ Experience in authoring and responding to communications with regulatory agencies.

_As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected_ _characteristics. As_ _a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:_

_EEOC Know Your Rights_

_EEOC GINA Supplement​_

_We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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://urldefense.com/v3/\_\_https:/www.msdprivacy.com/us/en/CCPA-notice/\_\_;!!DuJIhUBmA6S-!CgtKRhjWVCipNvp-c1-eOdkBke5VAYrFu\_nO9xLpgYVUG7B9RK2-jLDMORIX8RP5gTenY6eWKbGwCnces0j8YBDCEJ3Y\_AM$)_

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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/)

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

ADME, ADME, Assay, Assay Development, Bioanalysis, Bioanalytical Assays, Biochemical Assays, Biochemistry, Biopharmaceuticals, Cell-Based Assays, Cross-Cultural Awareness, DMPK, Drug Discovery Process, Gene Therapy, Immunoassays, Immunochemistry, Immunogenicity Assays, Innovation, Mentoring Staff, Modeling Simulations, Molecular Biology, Pharmaceutical Analysis, Pharmacokinetics, Regulatory Compliance, Results-Oriented {+ 5 more}

Preferred Skills:

Job Posting End Date:

06/4/2025

*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:** R350673