West Point, Pennsylvania

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified itslegacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our company's Research Laboratories is a true scientific research facility of tomorrow and will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Principal Scientist – Analytical Project Lead

The Analytical Project Lead (APL) serves as the primary point of contact for all analytical activities within the Vaccines Analytical Research and Development (V-AR&D) organization.

End-to-end technical analytical leader that translates regulatory guidance and product understanding into a robust analytical strategy to enable clinical studies and product licensure.

The technical analytical leader will work to define strategy and lead a cross-functional matrix team of analytical scientists in solving complex problems to facilitate vaccine process and formulation development. The qualified candidate will be responsible for the development of program-specific analytical strategy and for management of analytical timelines and deliverables for complex vaccines programs from preclinical candidate through late phase filing.

A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy. Established reputation for scientific excellence supported by publications and external presentations.

The responsibilities include coordination of analytical strategy including oversight of method development, testing, stability, extended characterization, in-process testing, and formulation development support through the coordination of cross-functional analytical representatives at working group meetings. The candidate will be expected to effectively communicate with stakeholders in partner organizations and to management and governance teams.

Primary Responsibilities:

  • Develop the analytical strategies and manage all analytical deliverables for given program(s) in a matrix team environment

  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

  • Serve as the point of contact and enable an effective partnership with key stakeholders including Process Development, Formulation Development, Global Clinical Supply, CMC Regulatory, Quality, Management and Governance teams

  • Prepare and/or provide oversight on the drafting of technical communications and other source documents to support regulatory filings

  • Develop overall CMC Analytical strategy, specification setting, develop characterization panel, stability strategy, and testing strategy for range finding/process development

  • Review quality agreements, determine strategy for assay siting, spending forecasting, feasibility/qualification/validation, manage events

  • Author and review CMC sections of INDs/BLAs/Type C/Scientific Advice documents, respond to CMC questions rapidly, Gather source documents and source mapping

  • Coordinate development, optimization, and pre-qualification activities of analytical methods

  • Partner with technical SMEs for facilitation of method establishment and transfer to internal and external partners

  • Partner with Development and Commercialization Team (DCT) representatives to support QbD activities and lead pCQA and analytical risk assessments.

  • Partner with functional area SMEs to develop phase appropriate Drug Substance and Drug Product specifications

  • Develop a central repository for key product knowledge and strategic decisions throughout the life cycle of the program

Preferred Experience and Skills:

  • Established scientific reputation supported by publications and external presentations.

  • Experience in analysis of large molecules (e.g., Size Exclusion Chromatography, Capillary Electrophoresis)

  • Familiar with ICH guideline of analytical procedure validation and transfer

  • Experience working in a GMP regulated environment

Education Guidelines:

  • B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 14 years of relevant experience; or Master’s degree with 11 years of relevant experience; or Ph.D. with 5 years of relevant experience.

  • Extensive experience in biochemical, biophysical, and biological activity-based assays.

  • Effective communication and leadership skills in a dynamic environment

  • Strong knowledge of requirements and experience in supporting health authority filings

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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.

Residents of Colorado

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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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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Pay Transparency Nondiscrimination

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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Work Week

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R135585

West Point, Pennsylvania

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

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