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Job Details


Merck & Co, Inc

CMC Regulatory Affairs Director - Biologics

Science and Research

Clinical Research Director

Yearly

No

North Wales, Pennsylvania, United States

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.

Attention NJ Applicants:

In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics

Under general supervision of an Executive Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. Ideal candidate will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Associate Principle scientist in support of their assigned projects.

Position Description

The Principal Scientist / Director responsibilities include but are not limited to:

  • Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products.

  • In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post approval changes.

  • The CMC Project Lead is accountable for the delivery of all regulatory milestones for higher complexity products including assessment of the probability of regulatory success together with risk mitigation measures.

  • Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.

  • Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation according to defined timelines.

  • Manage execution of CMC documentation including IND/CTA, original BLA/MAA, or Post Approval Life Cycle, including agency background packages and response to health authority questions per established business processes and systems.

  • Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness of submissions.

  • Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory CMC leadership team as appropriate.

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

  • Support new technology development within our Company.

  • Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval or continued market supply of our Company's Biologics products worldwide.

  • Conduct all activities with an unwavering focus on compliance.

  • May need to manage or mentor junior team members.

Education Minimum Requirement:

  • 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, Chemistry or Biochemistry.

Required Experience and Skills:

  • At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biologics or vaccine Regulatory CMC or development; manufacturing, testing, or licensure of biological products; or closely 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.

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 in particular with cross functional partners and health authorities.

Preferred Experience and Skills:

  • Experience in Biologics preferred

GRACSJOBS

#EligibleforERP

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

Click here to request this role’s pay range.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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.

Residents of Colorado:

Click here to request this role’s pay range.

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

Flex Time

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3

Requisition ID:R176633