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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Product Development Director (PDD) will be a member of the Operations Strategy & Pipeline Leadership (OSPL) team within the Product Development, Science & Technology (PDS&T) organization. Reporting to one of the Therapeutic Area Leads, the PDD will be responsible for pipeline programs from a Chemistry, Manufacturing, and Controls (CMC) perspective. They will lead the Product Presentation and Device Strategy Team (PPDST) and build the CMC development strategy for the late-stage assets, aligning with the clinical and regulatory development strategy from the Asset Strategy Team (AST). The programs can span modalities and presentations. Modalities can include small molecules, biologics (protein, gene therapy, toxin etc) and antibody drug conjugates. Product presentations can include oral dose, parenteralsand devices (therapeutics and aesthetic).
The PDD is accountable for creating a CMC development plan in collaboration with line functions and ensures strategic alignment with the enterprise functions (Clinical, Regulatory and Commercial) cross-functionally at the AST. The PDD is the spokesperson for CMC-related aspects at asset-level governances and represents the assets within Operations to ensure support of late-stage development activities and readiness for launch. They are responsible for communicating development and regulatory risks and seeking feedback from CMC leadership.
Key Responsibilities:
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 collaborates to ensure compliance with global regulatory and quality requirements. Participates in interactions with Regulatory and Health Authorities.
Critically evaluates and integrates drug substance, drug product, and device inputs to CMC team strategies and plans that align with corporate business objectives. Decision-making will often require assessment and integration of physical chemical properties, formulation science, engineering, analytical, and device technical information in conjunction with the project strategy, with full consideration of current regulatory and compliance requirements.
Manages multiple projects and contributes to project prioritization. Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieve efficiency with respect to time, and budget. Provides feedback to CMC management on resource and talent opportunities.
Reviews contracts with external partners and consultants. Develops a budget in collaboration with AST and obtains resources from functional areas. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness.
Promotes scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.
Ensures compliance with regulatory, health, safety and environmental requirements. Stay abreast of developments in global technical, regulatory and compliance arena and industry practice.
Qualifications
Bachelor’s Degree with at least 18 years of experience in CMC functions required; Master’s Degree with at least 16 years of relevant CMC experience required; or PhD with at least 10 years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget and resources.
*Location preference is Lake County, IL, also open to Worcester (MA) or Irvine (CA)
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html