Senior Manager CMC Product Development

• Represents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST and all line functions. Ensures high quality science technology deliverables and certifies compliance with global regulatory and quality requirements. Participates in meetings with Regulatory Authorities responds to regulatory queries and participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. risks and mitigations in collaboration with line functions and the Asset Strategy Team (AST).
• Leads PPDST and/or CMC development teams for assigned projects: schedules meetings develops agendas issues highlights apprises risks and plans with CMC Management conducts periodic reviews etc. to ensure that phase transition criteria are met in the most efficient and resource effective manner.
• Ensures strategic alignment with other key Development Sciences functions esp. Preclinical Toxicology/Biological Sciences and Quantitative Translational and Analytical Sciences (QTAS)/ADME (adsorption distribution metabolism and excretion) to ensure key deliverables for asset advancement are met and risks and mitigation plans are in place
• Drives legal and financial aspects of outsourcing contracts and statements of work (SOW). Demonstrates excellent interpersonal skills ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrates strong negotiating influencing and leadership skills.
• Leads PPDST and/or CMC teams and supports interactions for new due diligence / inlicensing opportunities and successfully transitions leadership for programs where development is internalized.
• Manages projects of utilizing matrix management approach. Negotiates for additional resources when required influences project timelines to ensure proper completion of required activities considering phase appropriateness. Implements creative approaches to maximize resource input and to achieve efficiency with respect to timelines and budget. Provides feedback and input to functional managers and identifies growth opportunities for team members. With guidance by senior PDD team member or management.
• Reviews contracts with Third Party Manufacturers and consultants. Develops budget needs in collaboration with AST obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of high quality deliverables with respect to science technology compliance and cost effectiveness.
• Promotes scientific and entrepreneurial thinking encourages creativity and manages quality and results with respect to science time budget and resources.
• Integrates and implements preclinical development plans and updates as necessary in collaboration with the global development teams and respective line functions.
• Ensures compliance with regulatory health safety and environmental requirements. Stays current with developments in global technical regulatory and compliance areas and industry practices.
• Apprises Management of plans and risks through regular communications periodic reviews in support of global filings and approvals. Responsible and supportive resp. for global filings of high quality CMC dossiers submission packages and regulatory agency interactions.

Qualifications :

• Bachelors Degree with at least 8 years of experience in a variety of relevant functions required; Masters Degree with at least 6 years of relevant experience required; or PhD with at least 4 years of relevant experience required. 04 years of working experience required in the same/similar role or in related CMC function.
• Ability to influence across the matrix leveraging knowledge of and networking with key internal/external partners and effective communicator in a transparent and courageous manner to all stakeholders
• Must have a good working knowledge of regulatory requirements and familiarity with relevant research instrumentation and techniques.
• Knowledge of pharmaceutical and drug development process.
• Must have CMC interdisciplinary experience and relevant expertise.
• Creative in implementing entrepreneurial thinking and making smart business decisions.
• Ensure high level of morale and collaboration in crossfunctional teams to maximize team impact and output.

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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 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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