Principal Scientist, Business Development & Acquisition, Operations PDS&T

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

As a Principal Scientist, Operations Strategy and Pipeline Leadership (OSPL) within the Product Development Science & Technology (PDS&T) function, you will play a critical role in evaluating the feasibility of programs identified for potential license or acquisition, ensuring both the viability of the program itself and AbbVie's ability to execute it post-acquisition. This role demands both internal and external-facing responsibilities, utilizing tools such as Smartsheets, Microsoft Office, and protected document vaults.

• Serve as the PDS&T CMC (Chemistry, Manufacturing, and Controls) lead for Corporate Licensing and Acquisition (L&A) diligence activities for external pipeline opportunities across various drug and combination product asset types and therapeutic areas.
• Represent PDS&T and partner with Development Sciences, Clinical, Regulatory, Quality, and Commercial Organizations during all phases of the Licensing process including diligence, negotiations, deal execution, and transition to internal teams.
• Perform initial technical assessment and lead cross-functional Operations experts in a full diligence assessment of CMC and commercial launch readiness risks and opportunities for all L&A prospects.
• Collaborate with Corporate L&A to ensure the deal model includes appropriate CMC development plans/resources aligned with the Clinical Development Plan, commercial launch, regulatory strategy, and overall deal structure.
• In partnership with all Operations functions and Development Sciences (R&D) CMC, establish a strategy and recommendations for assurance of supply, including product and process development and clinical/commercial supply chains.
• Communicate strategies, plans, and risks to Operations senior leadership through regular updates and periodic reviews throughout the diligence process and in support of potential deal execution.

Responsibilities & Primary Accountabilities:

• Execute CMC Due Diligence activities for PDS&T, integrating the CMC strategy with the Clinical Development plan, in support of Business Development opportunities for all therapeutic areas (TAs).
• Coordinate cross-functional Operations teams to ensure accurate and timely evaluations, including diligence site visits of external supply chains.
• Conduct critical technical evaluation of CMC drug substance, drug product, and device development information during the due diligence process.
• Establish CMC development strategies, risk assessments, and mitigation plans during diligence, aligning with Development Sciences CMC Functions, PDS&T, and Operations.
• Ensure resource planning for integration of acquired assets, including potential supplier assessment for clinical/commercial supply assurance.
• Prepare key CMC diligence findings and potential risks for the governance process on external opportunities.
• Post-deal execution, coordinate with PDS&T leadership to identify a CMC team lead, transfer diligence information to the internal team, and support program integration.
• Maintain organized records of evaluations and decisions within protected document vaults.
• Maintain agility to work in a high-volume, fast-changing environment.
• Communicate effectively both orally and in writing with internal and external stakeholders.
• Stay updated on global CMC technical, regulatory, compliance developments, and industry practices.

Qualifications

• Education: Bachelor's degree (14 years), Master's degree (12 years), or PhD (6 years) in Chemistry, Engineering, or a related field.
• Experience: At least 8 years in the pharmaceutical manufacturing industry, within Operations preferred.
• Analytical problem-solving abilities with demonstrated expertise in managing CMC due diligence activities with broad interdisciplinary knowledge and experience in pharmaceutical/combination product development, quality, regulatory/compliance requirements, budget, and resource planning.
• Proven track record of successful project development, demonstrating the ability to deliver timely, high-quality results in a cross-functional team environment.
• Demonstrated enterprise leadership skills managing multifunctional teams to evaluate target opportunities and produce high-quality analyses.
• CMC knowledge and experience across multiple therapeutic and/or functional areas, with experience across a range of development phases for objective evaluation of business opportunities.
• Experience in leading multiple complex projects with product development experience through IND and NDA (BLA)/MAA preferred.
• Effective oral and written communication skills.
• Ability to draw strategic insights from detailed evaluations.
• Senior executive management presentation experience desired.

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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