Senior Scientist, Process Development II

The ABC PDS&T Analytical Development team is seeking an analytical project lead to develop a comprehensive analytical strategy for mAbs ADCs bi-specifics fusion proteins AAVs etc. This position calls for a strategic thinker with a robust technical background in analytics coupled with the ability to lead cross-functional teams manage intricate projects and communicate effectively with stakeholders

Responsibilities

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Represent Analytical Development in AbbVies CMC teams providing support for both early and late-stage assets. Serve as the key contact for stakeholders ensuring balanced expectations between PDST and Analytical fields.
• Formulate and convey analytical strategies to Analytical PDS&T functions and CMC business partners guiding experimental execution for product analytical control strategies method development/validation/transfer and studies on release stability comparability and extended characterization of biologics.
• Manage a team by providing guidance and support to achieve goals. Foster a positive environment encourage development address performance issues and promote collaboration and communication.
• Lead analytical sub-teams translating development goals into practical analytical tasks and providing expert advice to peers and senior management.
• Design and implement work packages essential for achieving development and commercial objectives.
• Proficient in utilizing a broad range of analytical techniques to support DS process development characterization validation studies product liability assessments and analysis of impurities and variants.
• Analyze and identify data trends in key analytical release and stability assays showcasing scientific excellence in the analytical characterization of biologics.
• Draft and review Module 3 content for both early and late-stage programs as needed.
• Mentor peers in project management and the creation of analytical strategies.
• Communicate project strategy key issues and risks to relevant teams escalating risks and promoting resolution within and across functional areas.

Qualifications :

• BS or equivalent education and extensive typically 14 years of experience; MS or equivalent education with typically 12 years of experience; PhD with typically 6 years of experience in area or scientific area of discipline.
• Experience in managing and leading analytical development activities for biologic compounds such as mAbs bispecifics antibody-drug conjugates and/or fusion proteins along with a strong understanding of CMC analytical and regulatory requirements.
• Proficient in protein HPLC (e.g. SEC IEX RPLC) capillary electrophoresis (CE icIEF) and other separation techniques for protein analysis. Experience in mass spectrometry (intact/reduced LCMS peptide mapping) and ELISA is a good plus.
• Familiarity with industry USP/ICH guidance for the development qualification and validation of analytical methods.
• Hands-on experience in authoring reviewing submitting and responding to regulatory requests related to IND IMPD BLA/MAA. Skilled in technical writing including drafting method validation protocols/reports and comparability protocols/reports.
• Ability to work effectively across functions anticipating and addressing overall program development needs.
• Open to collaborative efforts valuing diverse perspectives and managing relationships effectively to enhance decision-making.
• A self-motivated meticulous individual who thrives in a fast-paced team environment.
• Exhibits creative and innovative thinking to tackle complex challenges and advocates for new technologies to fulfill project objectives.
• Quickly comprehends and adapts to new situations demonstrating agility when necessary.

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 Companys 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 an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

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