- Partner with Analytical Development groups to achieve commercial method readiness using traditional and advanced analytical techniques, including but not limited to HPLC/UPLC methods, gel and capillary electrophoresis, ELISA, bioassays, spectrophotometric and compendial methods.
- Participate in cross-functional, multi-site, global meetings / projects and oversee commercial analytical method transfer between sites, product/process investigations, method performance monitoring and troubleshooting.
- Establish scientifically sound, analytical lifecycle strategies, including methods, stability, specification and change management that meet Health Authority best practices and expectations.
- Participate in the preparation and review of technical documents to ensure global compliance - including validation protocols and reports, reference standard qualification reports and analytical test procedures.
- Author regulatory submissions, support regulatory inspections and provide scientifically sound responses to agency deficiency letters.
- Conduct periodic review of methods and work with program leads to design, execute remediation experiments, and implement changes to new or existing commercial methods when necessary.
- Qualifications
- PhD in Chemistry, biochemistry, biological sciences, or related scientific disciplines with 0-2 years relevant experience, or MS or BS with 9-12+ years relevant experience
- Industry experience in method development, qualification, validation, and method transfer in support of development and/or commercialization of biological products. Methods including but not limited to HPLC/UPLC, capillary electrophoresis, and spectrophotometric methods.
- Ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- 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. 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 Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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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Senior Scientist I - Massachusetts, United States - AbbVie
Description
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Senior Scientist I will be an integral part of the Analytical Development team in the Operations Science and Technology Biologics Division. The role involves managing all analytical aspects of biologics products on the market, overseeing commercial methods throughout their lifecycle - from method transfer, performance monitoring, troubleshooting, to method enhancement. The individual will also play a key role in establishing commercial product specifications, stability programs, and regulatory filings. Collaboration with other analytical teams, process development, global QC, and manufacturing science and technology groups is a crucial part of this role to meet business objectives and program milestones.
Responsibilities:
