Associate Scientist - Preclinical Development

Job Description

Our company's Device Development is seeking a highly motivated, talented engineer R1 with a strong background in Combination Product Development, Design Verification, and perform preclinical programs mechanical testing to join our department at our Research Laboratories in Rahway, NJ. The successful candidate will be part of a multi-disciplined team driving programs for oncology, neuroscience, cardiovascular, and infectious disease areas. Device development works through the preclinical development of Medical Devices and Combination Products for a wide range of Drug Product dose presentations, including parenteral, syringes, auto-injector pens, inhalation and nasal drug products. The ideal candidate will be adept in engineering assignments involving Develop innovative Design Verification mechanical tests, computer aided design (CAD) and rapid prototyping (e.g. 3D Printing) test fixture for combination products and Medical Devices testing, through Concept and Design phases, Implementation of lead prototypes, Verification of Design through finite element analysis (FEA) and Mechanical Testing through to Transfer and Validation of Device Design. You will be expected to work independently and to proactively collaborate with cross functional teams, leading pipeline products and standalone medical device designs.

Key Responsibilities and Primary Activities:

• Lead preclinical Design Verification development programs testing on interdisciplinary teams to advance the development of combination products

• Liaises closely with other partner functions including QA (Quality), Analytical Sciences, CROs and others to support project timelines.

• Develop innovative Design Verification strategies and mechanical tests with validations

• Generate design controls and risk management strategies

• May lead and implement departmental and inter-departmental initiatives (e.g. new technology, improved collaborations between different departments, development and implementation of new business processes, etc.).

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

• Work with cross-functional teams to assist in the development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle

• Design and rapid prototype medical device and combination products using state of the art tools including CAD, FEA, and 3D Printing.

• Work with second- and third-party suppliers and vendors

• Apply scientific and engineering expertise and research experience to solve problems creatively and independently.

• Drive in-vitro evaluations of Device Design for combination products and formulations.

• Identify, evaluate, and recommend new Device technology and instrumentation for the department.

• Document results in electronic notebooks and formal reports/memos as needed.

• Communicate findings and interpret results to key stakeholders via written reports and presentations.

• Contribute to development milestone reports and/or filing documents.

• May present to senior management, worldwide teams, or external audiences.

• Maintain established scientific and engineering excellence and commitment to innovation.

Requirement:

B.S degree in Mechanical Engineering or related scientific discipline with min 1 year of experience

Preferred:

• Familiarity with pharmaceutical development, combination product design controls, and device development

• Familiarity with leading a preclinical program and lab testing

• Familiarity with Industry Related Knowledge

• 21 CFR Part 4

• 21 CFR 820

• 21 CFR 211

• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics

• ISO 13485

• ISO 14971

• ISO 11608

• ISO 11040

• ISO 10993

#ETJOBS

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., 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.

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.

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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:

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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.

Residents of Colorado:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R197498