Job Description
Our team in West Point, Pennsylvania, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products.
As Director of the Vaccines Analytical Research and Development (V-AR&D) GxP team, you and your team of 15-20 scientists will partner with cross-functional development teams to enable pipeline decisions. The focus of this role is on the release and stability testing of all vaccine modalities – LVV, recombinant, and Nucleic Acids products. The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across modalities. The Director will oversee a broad portfolio of assays and projects inclusive of analytical method development, validation of GMP assays, supporting regulatory filings across the Vaccines development lifecycle, and GxP audit readiness. This role will also steer development and implementation of strategies within the Vaccines Analytical Separations, potency and residuals teams and at interfaces with strategic partners across CMC development, Regulatory, Quality, and commercialization and manufacturing areas.
Some of the main responsibilities include:
Promoting a team-first culture of openness and scientific dialogue.
Actively working with staff to encourage and facilitate their personal and scientific development.
Providing strategic, scientific, and operational management to the group responsible for developing results for vaccine process development and clinical manufacturing.
Leveraging your strategic thinking, proactively mentoring staff through validation design and execution
Enable Analytical Product Lifecycle Management (APLC) through efficient data capture.
Drive Organizational efficiency through proactively milestone setting and utilization of Key Performance Indicators and other metrics.
Drive completion of deviation closures and CAPA implementation
Ensure GxP labs are always in a state of audit readiness.
Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence.
Setting future strategies and bringing new technologies into the labs.
Education Minimum Requirements:
Ph.D. in analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 8 years of relevant experience;
OR M.S. with a minimum of 10 years of experience;
OR Bachelors with a minimum of 15 years of experience in the Pharmaceutical Industry.
Requirements:
A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.
Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.
Expertise in a broad range of techniques (chromatography, ELISA, qPCR, etc), including development, validation, transfer and execution in support of vaccines clinical release.
Strong working knowledge of regulatory guidance and have depth in authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.
Ability to manage effectively a portfolio of projects and multi-task in a highly dynamic environment, and influence cross-functional teams in a professional and positive manner.
Excellent verbal and written communications skills and an ability to excel in a team-based environment.
Preferred Experience and Skills:
Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
Proven ability to direct development of new, innovative approaches including your past work with new assay or robotic technology evaluation and shaping scientific strategy both at the platform and program level.
Position location: West Point, PA (onsite)
#AR&D
#EligibleforERP
Current Employees apply HERE
Current Contingent Workers apply HERE
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 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:
12/2/2024
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