Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and 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 an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Global Vaccines and Biologics Commercialization (GVBC) in Merck Manufacturing Division (MMD) manages commercialization of vaccines and biologics throughout launch to supply. Biologics and Vaccines Analytics (GVBC-BVA) provides analytical development, optimization, and support through a vaccine or biologic product's life cycle.
Activities within this dynamic environment include interfacing with a global network of product manufacturing and testing, collaborating with product development groups within MMD and Merck Research Laboratories (MRL), continuous improvement of analytical methodology, assay validation, analytical technical transfer, Biologics License Application preparation, and post-licensure support.
In this role, opportunities include but are not limited to the following:
- Polymerase Chain Reaction (PCR) based analytical testing for new and in-line vaccine programs in support of Value Chain Management Team objectives encompassing Cost of Goods (COGS) reduction, cold chain footprint reduction, and tactical process manufacturing and analytical capacity increases.
- Stakeholder collaboration including study design and project timeline development.
- Analytical testing support, troubleshooting, and optimization of analytical methods for in-line products.
- System administration for control of laboratory testing, laboratory data, material inventories, forecasting, and metrics.
- Collaboration with contract staffing on initiation, execution, and delivery of testing.
- Developing and delivering solutions for technical, logistical, and operational challenges in ambiguous situations.
- Analytical compliance and Quality support for investigations, corrective actions, and risk assessments.
- Participation in or leadership of the following team or departmental continuous improvement activities:
- Laboratory standardization, lean laboratory, and six sigma methodology.
- Assay Life Cycle program activities across various franchises and analytical platforms.
- Strategic initiatives within departmental and cross-functional teams (multiple sites and functions) representing GVBC-BVA.
The candidate will be responsible and accountable for activities within the opportunities above, escalate issues/challenges/needs that may impact deliverables, provide direction for contract staffing, and exhibit peer influence where necessary. Qualifications:
- Required: BA, BS or MS with laboratory experience in appropriate scientific areas relevant to this position, such as Biology, Biochemistry, Immunology, or Virology.
- Minimum of four (4) years of experience working in a laboratory environment with exposure to GMPs for candidates with a Bachelor's degree; Minimum of two (2) years of experience for candidates with a Master's degree
- Experience leading cross-functional teams or direct people management.
- Ability to work independently and collaborate as part of a team.
- Strong technical, communication (oral and written), interpersonal, and teamwork skills.
- Reliable with capability to lead and manage individual components of a project with adherence to timelines.
- Self-motivated with a positive attitude and proven performance record
- Ability to critically think through moderately complex problems, learn new techniques, and multitask effectively.
- Experience with continuous improvement or lean six sigma methodology.
- Experience within Microsoft Office 2010 and familiarity with Microsoft SharePoint.
- Knowledge of or experience in quantitative PCR (qPCR) or cell-based methodologies.
- Assay development and validation experience.
- Advanced experience within Microsoft Office (Excel Macros or Visual Basic for Applications) and experience with Microsoft SharePoint and Microsoft Project.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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