Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Analytical Quality Control program manager and primary planner of internal and external products ranging from new product introductions through commercialization. Assess and drive method changes, analytical improvements and provides technical support to cross-functional teams within and outside of QC during all stages of product development. Accountable for validation, method transfers, data analysis of study results, chromatographic overlays and trending of analytical data across multiple technologies all while maintaining and meeting the highest standard in quality, customer service and regulatory compliance.
•Acts as a technical expert and provides guidance (scientific and administrative) for all analytical grade levels
•Liaison between functional groups as well as sister divisions for a wide variety of analytical aspects including the meaning of analytical data from various sources; how the analytical data meets the client’s needs; the quality aspects of analytical projects and also timelines for analytical projects.
•Proactively and cooperatively communicates with peers, and communicates with management by proactively keeping management informed of results, of obvious and subtle problems and of likely potential problems, alternatives and their consequences.
•Develops and validates a wide variety of analytical test methods (i.e. ID, potency, impurities, solvents, particle size, etc.) and routinely keeps supervisor informed of progress and issues. Recognizes simple and complex technical issues which arise during methods development, evaluating alternatives and initiating corrective actions.
•Must be regarded to work independently to validate a wide variety of analytical test methods (i.e. ID, potency, impurities, solvents, particle size, etc.) using a variety of validation approaches. Routinely keeps supervisor informed of progress and issues.
•Initiates test method transfers by defining, interpreting and recommending acceptance criteria, proactively communicating with the other lab(s) and ensuring testing is completed in a timely manner.
•Proactively solves simple and complex problems through job knowledge; use of technical resources including technical literature and experts and well formulated, logical experimentation. Routinely makes recommendations to management regarding areas for development in order to reduce and control current and/or future problems.
•Manages whole projects. May establish schedules, project plans and direct activities of other scientists and non-scientists as well as provide training and development for others.
•Write/co-author memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and support quality control and manufacturing documents
•Presents results of projects to senior management when required and with guidance.
Qualifications
•BS in Science or related field with 8-10 years of experience
•MS in Science or related field with 6-8 years of experience
•PhD in Science or related field with 2-5 years of experience
•Has knowledge of computers and strong background in analytical testing experience in wet chemical, physical property testing, chromatography and/or spectrometric methods. Is knowledgeable of compliance requirements.
•Good organizational skills. Excellent communication (oral and written)and interpersonal skills. Can function as a team leader. Has knowledge of related area of development to incorporate into local problem solving. Must be able to work with Commercial Operations to determine prioritization of projects and meet tight deadlines. Use good judgment and make sound decisions. Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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