Associate Principal Scientist/Engineer, Drug Delivery Device and Combination Product Analytical

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Associate Principal Scientist/Engineer, Drug Delivery Device and Combination Product Analytical. The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for impactful physical, analytical & material science to support packaging production and commercialization of new product packaging and drug-delivery medical device/combination-products (MDCPs). As a Center of Excellence, we support the entire global-human-health portfolio and closely partner with various Packaging/Device Technology engineering groups, packaging sites, and other analytical groups.

The CPDA is located at our West Point, PA facility. We own and administer our company’s internal packaging technology laboratories, which we use for (1) non-compendial qualification of new components & configurations, (2) characterization and verification of MDCP design/functionality, and (3) applied science to advance significant technical investigations. The group also makes important contributions to new technology assessment, packaging control strategy, line qualification & quality risk management, authoring new filing sections, improving incoming/in-process/on-line physical testing at manufacturing sites, and, serving as the company experts on primary packaging barrier modeling & configuration design, container closure integrity (CCI).

The CPDA is seeking an Associate Principal Scientist/Engineer who, as an individual contributor, can act as an MDCP analytical lead for one or more exciting projects. A key aspect of the role is leadership, within a cross-functional working group, to develop & own both an analytical strategy (to satisfy Design Controls inputs) as well as the timeline, which includes managing analytical efforts. The role will naturally include substantial technical creative challenge for Device Characterization and more formal Design Verification, which includes development & validation of mechanical test methods as well as coordination & technical oversight for internal CPDA staff or external lab testing (where required) to meet project timelines and deliverables. To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science relevant to mechanical devices, as well as be a highly effective communicator (written and verbal), collaborator and technical coach. Ideally, the candidate has prior hands-on analytical experience with MDCP and Design Controls.

Education Requirement (minimum):

• MS or Ph.D. in Mechanical, Chemical or Biomedical Engineering (or equivalent field)

Required Experience and Skills:

• A minimum of 3 years with Ph.D. (6 years with MS) in a role responsible for medical device or combination product development verification, method development and testing.

• Experience with mechanical testing, imaging, and measurement equipment and techniques. Including (but not limited to) tensile/compression/torsional testing, materials characterization, x-ray computed tomography, rheonmetry, and microscopy.

• Excellent collaboration and leadership skills, to work as part of cross-functional teams to meet project timelines and deliverables.

Preferred Experience and Skills:

• Experience developing innovative Device Characterization and Design Verification (DV) strategies/mechanical tests with validations, incl. engineering studies, design verification protocols, stability studies and validation protocols, with appropriate selection of acceptance criteria.

• Experience with medical device development with understanding/familiarity of Design Controls (21 CFR 820.30) and relevant industry standards is a plus.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Rahway, 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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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:

Relocation:

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Flexible Work Arrangements:

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Hazardous Material(s):

Requisition ID:R241781