Associate Principal Scientist, Device Analytical Lead in Analytical Research & Development (Hybrid)

Job Description

An excellent opportunity is available for an Analytical Research and Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at various stages of development. In this pivotal position, the successful candidate will spearhead analytical device activities across multiple MDCP programs, serving as a key member of the Combination Product Analytical sub-team within the Combination Product Working Group.  The Device Analytical Lead will partner closely with cross-functional teams, including device development and technology, quality assurance, and analytical teams involved in GMP activities, validation and Quality Control testing. This role will be instrumental in establishing timelines for clinical deliverables and ensuring commercial laboratory readiness for product launches.

Bring energy, knowledge, and innovation to carry out the following:

• Take the lead in overseeing device GMP analytical activities for multiple MDCP programs

• Execute AR&D’s device strategy and optimization of the operating model to deliver results aligned with enterprise goals

• Develop an incoming and release testing strategy, lead siting discussions for clinical and commercial testing, and develop specifications

• Ensure adherence to timelines by effectively managing all analytical activities to support on time release of clinical supplies

• Work with the validation team on method validation and transfer activities at clinical GMP labs and commercial QC labs

• Partner with cross-functional device, analytical, regulatory and quality functions within our divisions to manage End-to-End MDCP testing activities including internal and external device testing activities

• Support regulatory filings through documentation authoring and reviews (i.e. INDs, BLAs, etc.)

Required experience & skills: 

• A Ph.D. with a minimum of 3 years of relevant work experience or a Master’s degree with a minimum of 6 years of relevant work experience or a Bachelor’s degree with a minimum of 8 years of relevant work experience

• Proven track record of successful project management, encompassing resource management, risk assessment and mitigation strategies, as well as the ability to effectively track, support and communicate the timely delivery of project milestones

Preferred experience & skills: 

• In-depth knowledge of medical device CMC landscape including knowledge of ISO standards, EU MDR, GMP, ICH and relevant HA guidelines

• Experience with medical device development with understanding of Design Controls (21 CFR 820.30)

• Extensive experience with a wide variety of device analytical methods, including but not limited to, device functionality testing and container closure integrity (CCI) testing

• Outstanding communication, critical thinking, and leadership skills

• Proficient in navigating fast-paced and dynamic work environments

• Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines

#eligibleforERP

#AR&D

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected