12 days old

Senior Scientist, Biologics - Regulatory Affairs CMC

Merck
North Wales, Pennsylvania
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

About Us

We are one company, but we operate under two different corporate brand names. We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else

Job Description

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 directing edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.

Primary Responsibilities include:

  • Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects.  Be accountable for the delivery of all regulatory milestones through product development and/or post-approval life cycle.
  • Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks.
  • Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post-approval/variations, agency background packages, and responses to health authority questions per established business processes and systems. 
  • Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed
  • Conduct all activities with an unwavering focus on compliance

Requirements

Education

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

Required Experience and Skills 

  • 5 years of Regulatory CMC related experience, relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing, and/or related field.

Preferred Experience and Skills

  • Experience in biologics Regulatory CMC preferred
  • Experience in cell and gene therapy preferred

GRACSJOBS

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. 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.

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

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.

Categories

Posted: 2021-07-15 Expires: 2021-08-14

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Senior Scientist, Biologics - Regulatory Affairs CMC

Merck
North Wales, Pennsylvania

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