Director, CMC Product Development - Late Stage, Operations

AbbVie; North Chicago (IL); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie seeks a Product Development Director (PDD) to lead CMC development and strategy within the Operations Strategy & Pipeline Leadership team. You will guide late-stage asset programs, align with regulatory and clinical plans, and present CMC perspectives at governance forums.

You will manage budgets, collaborate with cross-functional partners, ensure quality, and drive risk management for regulatory filings and launches across modalities, including small molecules, biologics, and devices.

Qualifications

• Bachelor’s/Masters/PhD with extensive CMC leadership and global regulatory exposure.
• Experience leading CMC teams through regulatory submissions (NDA/BLA/PMA/510K preferred).
• Excellent scientific writing and verbal communication skills.
• Strong regulatory knowledge and familiarity with CMC development approaches (device regulatory knowledge preferred).
• Knowledge of pharmaceutical sciences and drug/device development process.
• CMC interdisciplinary experience and leadership capabilities.
• Strong negotiating, influencing and leadership skills.

Responsibilities

• Represent all CMC areas on the AST and coordinate with line functions.
• Integrate drug substance/product and device inputs into CMC strategies aligned with business objectives.
• Manage multiple projects, prioritize resources, and optimize time and budget.
• Review contracts with external partners and manage budget with AST.
• Represent AbbVie in high-profile partnerships and development decisions.
• Foster scientific thinking, creativity, and high-quality deliverables.
• Ensure regulatory, health, safety and environmental compliance.
• Report plans and risks to CMC leadership and support global filings/launches.

Skills

Scientific writing

Regulatory knowledge

Leadership

Negotiation

Cross-functional collaboration

Education

Bachelor’s Degree with 18+ years CMC experience

Master’s Degree with 16+ years CMC experience

PhD with 10+ years CMC experience

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose

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, parenteral and 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.

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.
• Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving decisions for the development programs.
• 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.
• Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.
• Ensures high level of morale in the CMC team.

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.
• Multiple product development experiences of leading a CMC team through regulatory submissions (NDA/BLA/PMA/510K preferred).
• Must possess good scientific writing skills and good verbal skills.
• Must have a good working knowledge of regulatory requirements and familiarity with relevant CMC development approaches. (Device regulatory requirements preferred.)
• Knowledge of pharmaceutical sciences and the drug/device development process.
• Must have CMC interdisciplinary experience and expertise.
• Possess negotiating, influencing and leadership skills. Creative in implementing entrepreneurial thinking and capable of making smart business decisions.

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 thisposting 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 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 anduntil 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html