Director, PDS&T Analytical CMC Development

AbbVie; Massachusetts; On-site; USD 140,000 - 220,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a senior leader for Biologics Analytical-CMC Strategy in the United States to guide late-stage development, method development, validation, and regulatory alignment for gene therapy and tLNP technologies. The role focuses on establishing robust analytical control strategies and enabling critical BLA activities.

You will coordinate cross-functional teams, drive project timelines, and communicate strategy and risks to stakeholders while supporting resource planning and

Qualifications

• Strategic thinker with strong analytical background in gene therapy and tLNP technologies.
• Experience in research and/or development environment.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups and maintains strong internal/external relationships.
• Ability to influence across scientific disciplines and balance stakeholder expectations.

Responsibilities

• Drives analytical control strategy, including specifications, CQAs, shelf-life, and risk-based comparability for the biologics pipeline.
• Establish collaborations across the organization to enable critical BLA activities.
• Set team strategies, manage resources, and define risk mitigation.
• Communicate project strategy, issues, and risks to teams and elevate cross-functional risks.
• Act as principal contact for stakeholders and balance expectations across functions.
• Participate in yearly FTE planning across the analytical organization.

Skills

Strategic thinking

Cross-functional collaboration

Communication

Project management

Analytical skills

Regulatory knowledge

Education

Bachelor’s degree in Science or related field

Master’s degree in Science or PharmD

PhD in Science or related field

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, Xand YouTube.

Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control strategy for late-stage development of biologics. The Analytical CMC Strategy team is responsible for ensuring late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross-functionally with process development, regulatory, and quality within the Abbvie network. This role requires a strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, manage complex projects, and effectively communicate cross-functionally.

Responsibilities

• Drives overall analytical control strategy, including justifying appropriate specifications, determining critical quality attributes, assessing product shelf-life, and risk-based comparability strategies for the biologics pipeline.
• Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities.
• Setting team strategies, managing resources and defining risk mitigation strategies.
• Communicate project strategy, key issues, and risks to relevant teams and elevate risks and facilitate resolution within/across functional areas.
• Act as the principal contact for all stakeholders and balance conflicting expectations between cross-functional areas.
• Actively participate in yearly FTE planning across the analytical organization

• Bachelor’s Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master’s Degree or equivalent education Science or PharmD or equivalent education with extensive (typically 16 years) of related work; PhD in Science or related field with typically 10 years of related work experience.
• Experience in research and/or development environment.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.
• Demonstrated ability to influence others across areas of scientific disciplines.
• Technical background in healthcare, laboratory diagnostics, medical devices or pharmaceutical companies.
• This role requires a strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, manage complex projects, and effectively communicate cross-functionally.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html