Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ﬁngersticks.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents
Our location in Santa Clara, CA, currently has an opportunity for a Senior Staff Research Scientist
What you’ll do:
This individual will support the development, validation and transfer of analytical test methods to commercial manufacturing sites, contribute to regulatory submissions and submission responses for new products or product changes and provide troubleshooting/continuous improvement support to commercial testing laboratories.
Key Responsibilities Include:
- Develop, validate, transfer and troubleshoot analytical methods, including API, raw materials, in-process and finished drug product; author, review and verify validation and transfer protocols and reports. Must have in-depth knowledge and extensive hands-on experience with LC / LC-MS and GC / GCMS method development.
- Interpret analytical data, recommend specifications and methods for process or product characterization
- Anticipate, recognize and resolve complex technical issues through job knowledge, use of technical resources including technical literature and experts and well formulated, logical experimentation.
- Advance the technical capabilities of the department by evaluating, recommending and implementing new technologies to meet business needs.
- Serve as the analytical representative and/or lead cross functional project teams; actively participate in team efforts and contribute to technical evaluations and solutions
- Author quality and regulatory test method documents
- Write/co-author Regulatory Submissions sections of the CMC for IDEs and PMAs), memos and scientific reports in support of Regulatory Submissions and support quality control and manufacturing documents
- Manage analytical projects.
- Establish schedules, define dependencies and project plans, perform technical and quality risk assessments and direct activities of other scientists as well as provide training and development for others.
- Present project results and recommendations to senior management
- Provide guidance (scientific and administrative) for junior analytical scientists.
- Serve as a liaison between functional groups and external customers for analytical development, transfer, troubleshooting and improvement efforts.
- Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise
- Maintain and meet the highest standards in quality and regulatory compliance.
- Follow, understand and comply with AV SOP’s and policies on cGMP’s and safety.
- Must have in-depth knowledge and extensive hands-on experience with LC-MS and GC method development
- Must have extensive experience with method validation and transfers for analytical methods according to current regulatory guidelines.
- Extensive experience on chemical characterization with various spectroscopic techniques and familiar with extractable and leachable evaluation requirements for wide range of materials and medical devices.
- Internal/external authority for technical issues.
- Evaluates and defines function activities for projects and determines appropriate timeline; coordinates activities with functional resources; keeps functional activities on schedule
- Demonstrates expertise in different analytical techniques, theory, application, troubleshooting, etc. Advanced knowledge of area of analytical chemistry is required. Applies advanced principles, theories, and concepts in area of specialty. May contribute to the development of new concepts, practices and standards.
- Directly or indirectly supervises/mentors others; delegates activities appropriately.
- Demonstrates excellent verbal and written communication skills.
- Develops alternatives and solutions for a range of complex problems. Solutions require creativity, critical thinking, and collaboration, considering a broad range of potential impacts, including those that are downstream.
- Extensive experience in preparing regulatory submissions.
- B.S., M.S., PhD in Analytical Chemistry and experience in Analytical R&D, technical support or QC operations.
- B.S. in science or related field with 8+ years relevant experience OR
- M.S. in Science or related Field with 3+ years relevant experience preferred OR
- Ph.D. in science ore related field; 2+ years post-graduate and/or industrial experience preferred.
- Proficiency in standard office software and wide analytical experience in test method development, validation, transfer and troubleshooting, including gas and liquid chromatography, wet chemistry, spectroscopy and physical property testing.
- A working knowledge of Empower and LIMS is highly desirable.
- Is knowledgeable of cGLP requirements and ICH guidelines
- Has exceptional problem solving and organizational skills
- Excellent communication (oral and written) and interpersonal skills; ability to work well with a wide range of functional groups including R&D, QC, QA, Regulatory Affairs, and Commercial Operations
- Can function both independently and as a team player
- Must be adaptable and able to operate effectively in a highly dynamic environment
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL OF EXPERIENCE.
WHAT WE OFFER
- At Abbott, you can have a good job that can grow into a great career. We offer:
- A fast-paced work environment where your safety is our priority
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Abbott is an Equal Opportunity Employer, committed to employee diversity.