Abbott STAFF SCIENTIST - ANALYTICAL CHEMIST in Santa Clara, California

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.

Primary Job Function.

Responsible for analytical methods development. Conceive and execute novel scientific research or new operations or 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. This individual will support the development, validation and transfer of analytical test methods to commercial sites, contribute to regulatory submissions and submission responses for new products or product changes, provide analytical and bioanalytical support for AV product development, as well as to provide troubleshooting/on-going improvement support to commercial testing laboratories. Some key responsibilities include:

  • Develop, validate, transfer and troubleshoot analytical/ bioanalytical methods, including APIs, raw materials, in vitro / in vivo preclinical study samples, 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 in method development and chemical characterization using HPLC, GC, GCMS, and LC-MS and other spectroscopic techniques)

  • 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. Define dependencies and project plans, perform technical and quality risk assessment, direct activities of other scientists as well as provide training and development for others, present project results and recommendations to senior management

  • 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 GLP’s and safety

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.

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. Maintain a high level of productivity. The essential capability includes:

  • Must have hands-on experience with analytical and bioanalytical methods development, validation, and transfer.

  • Must have in-depth knowledge on analytical techniques, cGMP/GLP regulations and capable to operate analytical laboratories with regulatory compliance requirement.

  • Advanced knowledge of area of analytical chemistry is required. Capable to apply advanced principles, theories, and concepts in area of specialty, and contribute to the development of new concepts, practices and standards.

  • Excellent verbal & written communication skills and task management capability

  • Excellent interpersonal skills and capable to work cohesively with team members within the group and across the functional areas.

Supervisory / Management Responsibilities Likely to supervise a team of one or more and evaluate the performance of those individuals. Is accountable for effective performance of the team and/or

individuals. Set an example by creating an open environment of mutual respect

and honesty and by focusing on the facts and data. Directly or indirectly supervises/mentors others; delegates activities appropriately

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. Supervise one or more direct reports and

proactively engage in their development. 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 in Chemistry, Biology, or related scientific field, plus 8+ years of relevant work experience, or equivalent combination of education and

experience. Master’s degree preferred 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. Masters/PhD (Analytical Chemistry or Organic Chemistry) 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, drug products and drug-device combination products in a regulated environment.

** Extensive working experience under GMP and GLP conditions, with firm

knowledge of cGMP, ICH, USP and FDA guidelines.

** Must have in-depth knowledge and extensive hands-on experience in method development and chemical characterization using HPLC, GC, GCMS, and LC-MS and other spectroscopic techniques, such as FTIR, Raman, and thermal analysis experience.

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

** This position is a Lab position. Candidate must be a hands-on Scientist who likes to conduct experiments/research in a lab environment.

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