Hiring company: Merck
Job Description
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
The Senior Principal Scientist, Microbiology is accountable for providing technical leadership supporting the clinical development space across the Research Division. This includes not only oversight of the execution of GMP release and stability activities supporting the development pipeline, but facility environmental monitoring, and technical leadership of analytical method transfer from the embedded microbiology development team, transfer support to commercial sites and supporting regulatory filings including INDs/IMPD, NDAs, and BLAs. The Sr. Principal Scientist is also responsible for evaluation and implementation of new analytical technologies, including continued development and execution on rapid microbiology methodology implementation.
Strategic partnering with Development teams, Analytical Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential. The incumbent will also be key in partnering across our Microbiology Network, both within our research site-based microbiology teams, and strategically across our network with the Microbiology COE and commercial sites to ensure line of sight to analytical transfers and with industry forums and regulatory partners to drive forward looking strategies.
The Senior Principal Scientist reports into Small Molecule Analytical Research and Development. The position is accountable for delivering phase-appropriate qualification/validation, verification of compendial microbiological and IPC assays, execution of on-time release, stability and environmental monitoring, partnering with interfacing teams to transfer and implement forward looking analytical technologies and innovative approaches, and GMP execution with the highest scientific standards. The incumbent will be responsible for providing leadership for equipment readiness, documentation systems, authoring, reviewing and approving of GMP documentation, review and approval of site and global SOPs.
The successful candidate must function well and be able to partner in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including strong background and experience in microbiological and analytical chemical techniques, project and team management and publication of research results. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and alliance with various partners and stakeholders in development.
Education Minimum Requirement:
Ph.D. in microbiology or related field with 8+ years of relevant experience in the pharmaceutical industry; MS with 10+ years of relevant experience; BS with 14+ years of relevant experience in the Pharmaceutical Industry.
Position Qualifications:
Excellent verbal and written communication skills in English and preferred business-proficient to fluent in German, demonstrated creativity, strong interpersonal and collaborative skills
Demonstrated ability in leading cross-functional groups with proven talent development skillsets.
Ability to work in a team environment with cross-functional interactions is essential
Strength in delivering results on firm deadlines in support of compound from development through commercialization
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.
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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Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
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Number of Openings:
1