Senior Scientist, Regulatory Affairs, Vaccines- Chemistry, Manufacturing, Control

Merck & Co., Inc. North Wales , PA 19454

Posted 3 weeks ago

Job Description:

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Reporting to the Director, the Senior Scientist is responsible for implementing Chemistry, Manufacturing and Control (CMC) regulatory strategies for our Company's vaccine products in accordance with global regulations and guidance's, and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Primary responsibilities include, but are not limited to:

Primary Responsibilities:

  • The CMC Project Lead is accountable for the delivery of all regulatory milestones for less complex projects through the product life cycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.

  • Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects.

  • Lead execution of CMC documentation including investigational new drug application (IND)/clinical trial application (CTA), new drug application (NDA)/ biologics license application (BLA)/marketing authorization application (MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.

  • Conduct all activities with an unwavering focus on compliance.

Education Minimum Requirements:

  • B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Biochemistry, or Pharmacy.

  • At least five (5) years of relevant experience, including biological/vaccine research; manufacturing, testing, or licensure of biological/vaccine products; or related fields.

  • The candidate must be proficient in English; additional language skills are a plus.

Required Experience and Skills:
  • Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.

  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.

  • Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance).

  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.

  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

  • Demonstrated effective leadership, communication, and interpersonal skills.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And 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.

Residents of Colorado

Click here to request this role's pay range.

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.

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

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time, Remote Work, Telecommuting

Shift:

1st

  • Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2

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Senior Scientist, Regulatory Affairs, Vaccines- Chemistry, Manufacturing, Control

Merck & Co., Inc.