AbbVie Senior Scientist I Analytical Chemistry in Lake County, Illinois
Provide technical support for analytical methodologies in commercial and development phases of API manufacturing and project leadership in representation of the analytical team to the cross functional CMC team. This role will be based out of our North Chicago facility. 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.
This position is part of a hierarchical continuum and will be filled at a level consistent with the education and experience of the best candidate.
Key Responsibilities Include:
- Develop, validate, transfer and troubleshoot API analytical methods, including raw materials, in-process and API testing
- Interpret analytical data, recommend specifications and methods for process or product characterization
- Anticipate, recognize and resolve simple and complex technical issues through job knowledge, use of technical resources including technical literature and experts and well formulated, logical experimentation.
- Serve as analytical representative to cross functional project teams; actively participate in team efforts and contribute to technical evaluations and solutions
- Author, review and verify validation and transfer protocols and reports
- Author quality and regulatory test method documents
- Write/co-author memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and support quality control and manufacturing documents
- Manage analytical projects. Establish schedules, define dependencies and project plans and direct activities of other scientists and non-scientists as well as provide training and development for others
- 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
- Capable of working fully independently
- Maintain and meet the highest standards in quality, customer service and regulatory compliance
- Follow, understand and comply with AbbVie SOP’s and policies on cGMP’s and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas
- BS degree in Science or related degree with 5-8 years of experience preferred. OR MS degree in Science or related degree with 3-6 years of experience preferred. OR Ph.D. / Pharm.D. in Science ore related field; with 1-2 years of experience preferred.
- Has proficiency in standard office software and analytical testing experience in wet chemistry, gas and liquid chromatography and/or spectrometric test methods. A working knowledge of Empower, Fusion, LIMS, Nugenesis, VMS and QDMS is highly desirable.
- Is knowledgeable of cGLP requirements and familiar with ICH guidelines
- Has strong 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
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Travel: Yes, 10 % of the Time
Req ID: 1703812
Equal Opportunity Employer Minorities/Women/Veterans/Disabled