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Staff Scientist - Analytical Chemist

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
CANDIDATE CAN BE BASED OUT OF SYLMAR, CALIFORNIA OR TEMECULA, CALIFORNIA OR SANTA CLARA, CA
Responsible for generating technical content for global regulatory submissions related to analytical method development. Conceive and execute new operations for processes that achieve project and area goals. Generate new proposals and lead those efforts. Investigate, identify, develop, and optimize new methods, processes or techniques. Write protocols, reports and amendments. Perform validations for methods, processes or equipment. Coordinates with collaborators for execution of protocols and studies. Act as a lead scientist in his/her area of expertise on one or more projects. Critically evaluate relevant scientific advances or regulatory requirements and integrate this knowledge into programs.
Core Job Responsibilities
+ Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for comprehensive understanding within his/her area of expertise on one or more project teams.
+ Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
+ Publish research in peer-reviewed journals and present work at scientific/technical conferences.
+ 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
+ Oversee the design, implementation and execution of protocols and studies.
+ Proactively seek out new information in the literature, regulations or other sources and incorporate this into individual project(s) as well as the overall program.
+ Seize opportunities to pursue project relevant leads that are in line with the group?s strategy.
+ 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.
+ Maintain a high level of productivity.
Supervisory / Management Responsibilities
Provide guidance (scientific and administrative) for junior scientists and engineers. Set an example by creating an open environment of mutual respect and honesty and by focusing on the facts and data.
Position Accountability / Scope
+ Demonstrate a high degree of responsibility in maintaining scientific standards and safe laboratory practices for self and reporting staff.
+ Participate in establishing project goals, defining short and long-term scientific, technical or operational strategies, and contribute to the generation of project-related documents and presentations.
+ Keep accurate and current records according to Abbott policies.
+ Use external information to gain competitive intelligence. Act as advocate to integrate this knowledge into the group's research efforts.
+ Generate new research strategies to effectively address project and divisional goals.
+ Collaborate with functional and technical experts to facilitate scientific achievement.
+ Publish project-related research in high-impact factor peer-reviewed journals and R&D reports.
+ Primary inventor of patents.
Minimum Education
Bachelor's degree (Chemistry, Biology, or related scientific field,) plus 8+ years of relevant work experience, or equivalent combination of education and experience. Master?s degree combined with 6+ years of relevant experience, or PhD combined with 3+ years of relevant work experience.
Requires complete understanding of specified functional area. Advanced degree preferred.
Minimum Experience / Training Required
+ Experience in the theoretical and practical fundamentals and experimental research techniques in chromatography, polymer chemistry and spectroscopy.
+ Extensive analytical, design and problem solving skills specific to development, qualification, validation and transfer of diverse analytical methods for characterization & release/stability testing of APIs, raw materials, and drug products in a regulated environment.
+ Extensive working experience under GMP and GLP conditions, with firm knowledge of cGMP, ICH, USP and FDA guidelines.
+ Experience in preparing regulatory submissions
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION - OPEN TO CONSIDER CANDIDATE WILLING TO RELOCATE AT THEIR OWN EXPENSE.
OPEN TO CONSIDER LOWER LEVEL CANDIDATE.
CANDIDATE CAN BE BASED OUT OF SYLMAR, CALIFORNIA OR TEMECULA, CALIFORNIA OR SANTA CLARA, CA
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com


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