Principal Scientist/Director - CMC Chemistry, Manufacturing And Control - Regulatory Affairs

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

Posted 3 weeks ago

Job Description:

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network 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 Executive Director,the Principal Scientist is responsible for developing and implementing Chemistry, Manufacturing and Control (CMC) regulatory strategies for our vaccine products in accordance with global regulations and guidances and isresponsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Primary responsibilities include, but are not limited to:

Primary Responsibilities:

Regulatory Responsibilities:

  • The Principle Scientist is accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle 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 projects of increasing complexity.

  • Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.

  • Manage execution of CMC documentation including investigational new drug (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.

  • Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our vaccine products worldwide.

  • Conduct all activities with an unwavering focus on compliance.

Technical Skills:

  • Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.

  • Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.

  • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

Leadership Skills:

  • Demonstrated ability to generateinnovative solutions to complex regulatory 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, interpersonal and negotiating skills.

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, or Biochemistry.
Required Experience and Skills:
  • At least fifteen (15) years of relevant experience (10 years with an advanced degree), 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.

  • The candidate may be required to travel on a periodic basis.

Please note, relocation assistance is not provided for this position.

GRACSERP

We are a research driven bio-pharmaceutical 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. 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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

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

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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:

Not Specified

Shift:

1st

  • Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Scientist/Director Global Vaccines Regulatory Chemistry Manufacturing And Control

Merck & Co., Inc.

Posted 2 months ago

VIEW JOBS 9/24/2020 12:00:00 AM 2020-12-23T00:00 Job Description Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network 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 Associate Vice President, the Principal Scientist is responsible for implementing Chemistry, Manufacturing and Control (CMC) regulatory strategies for our vaccine products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Responsibilities include, but are not limited to: Primary Responsibilities: Regulatory Responsibilities: * The Principal Scientist is accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle 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 projects of increasing complexity. * Provide regulatory leadership, as needed, in product in-license/due diligence review, product divestment and product withdrawal. * Manage execution of CMC documentation including investigational new drug (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. * Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our vaccine products worldwide. * Conduct all activities with an unwavering focus on compliance. Technical Skills: * Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. * Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. * Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: * Demonstrated ability to generate innovative solutions to complex regulatory 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, interpersonal and negotiating skills. Please note, relocation assistance is not provided for this position. 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, or Biochemistry. * At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biological/vaccine research; manufacturing, testing, or licensure of biological/vaccine products; or related fields. Required Experience and Skills: * At least three (3) years supervisory experience required. * At least five (5) years of Regulatory CMC experience. * The candidate must be proficient in English; additional language skills are a plus. * The candidate may be required to travel on a periodic basis. 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 … Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development. 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. US and Puerto Rico Residents Only: If you need an accommodation for the application process please email us at staffingaadar@msd.com For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations. 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: No Travel Requirements: 10% Flexible Work Arrangements: Not Specified Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Number of Openings: 1 Merck & Co., Inc. North Wales PA

Principal Scientist/Director - CMC Chemistry, Manufacturing And Control - Regulatory Affairs

Merck & Co., Inc.