Senior Scientist, Chemistry, Manufacturing and Control - Devices and Drug-Device Combinations

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.

The Senior Scientist in Devices and Drug-Device Combinations (DDDC) Chemistry, Manufacturing and Control (CMC) is responsible for DDDC CMC regulatory activities for our products in accordance with global regulations, standards and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Product responsibilities may be in the small molecules, biologics or vaccines portfolio, and could be in the development or marketed product phase of the product life cycle. Primary responsibilities include, but are not limited to:

Primary Responsibilities:

• Provide scientific input into DDDC regulatory strategy(ies) by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.

• Lead and/or support the CMC Product Team on the device aspects of assigned combination products and be accountable for the delivery of all assigned regulatory activities. 

• Support technical content writing and review in CMC documentation including investigational new drug (IND)/clinical trial application (CTA), original new drug application (NDA)/ marketing authorization application (MAA), agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems. 

• Identify, communicate and escalate potential issues to Regulatory CMC Product Lead, line management and relevant stakeholders.

• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide. 

• Conduct all activities with an unwavering focus on compliance, including staying current on all training.

• Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements.

• Additional activities may be assigned by the supervisor.

Technical 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, medical devices).

Leadership Skills:

• 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 communication, and interpersonal skills.

Education Minimum Requirements:

• B.S. in a biological science, engineering, or a related field (advanced degree preferred).

• Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry

Required Experience and Skills:

• At least two (2) years of relevant experience in the area of medical devices and/or combination products which may include biological/pharmaceutical research, manufacturing, testing, or regulatory CMC. Candidates with advanced degrees with less than two (2) years' experience will also be considered.

Preferred Experience and Skills:

• Ability to critically review detailed DDDC scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

• Scientific curiosity, exemplified by a passion to continue to learn and by proactively identifying areas of self-development and growth.

• Technical leadership skills, as well as an understanding of related chemical and pharmaceutical operations (e.g., drug substance or drug product manufacturing, process development, analytical, quality assurance).

• Demonstrated ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities.

• Superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.

• Excellent interpersonal, verbal and written communication, presentation, and listening skills.

• Proficient in English; additional language skills are a plus.

GRACSERP

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.

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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R88992