Director of Molecular & Virus Safety Assays ( MERCUSR104637ENUS)
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.
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.
You and your team will partner with cross-functional development teams to enable pipeline decisions. In this role the focus is on designing analytical strategies to release virus and cell banks, and development and implementation of novel molecular assays and next generation sequencing approaches for release and characterization of drug substance and drug product. 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 be oversee a broad portfolio of molecular and cell-based assays and projects inclusive of analytical method development, transfer to GxP laboratories and supporting regulatory filings across the development lifecycle. This role will also steer development and implementation of strategy within the cell-based sciences team and at interfaces with strategic partners across CMC development, Regulatory, Quality, and commercialization and manufacturing areas.
Some of the main responsibilities include:
Providing strategic, scientific, and operational management to the group responsible for providing upstream analytical packages and molecular analytical results for vaccine process development and clinical manufacturing.
Actively working with staff to encourage and facilitate their personal and scientific development.
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.
Responsible for scientific over-sight of work outsourced to Clinical Research Organizations (CROs) in collaboration with others to ensure data quality and accuracy is aligned with our company's expectations.
Education Minimum Requirements:
Ph.D. in analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 5 years of relevant experience; OR M.S. with a minimum of 8 years of experience; OR Bachelors with a minimum of 15 years of experience in the Pharmaceutical Industry.
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 molecular biology, next generation sequencing and/or virus/microbiological safety assays and techniques, including design, development, transfer and execution in support of vaccines process development.
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
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Invent. Impact. Inspire.
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.
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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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