Director, PDS&T Analytical CMC Development

AbbVie Inc.; Worcester (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a senior leader for Biologics Analytical-CMC Strategy within PDS&T to drive analytical control strategies for late-stage biologics. You will partner cross-functionally with process development, regulatory, and quality to enable regulatory submissions and robust method development.

The role calls for a strategic thinker with extensive industry experience in gene therapy and tLNP technologies, a track record of scientific innovation, and the ability to steer complex projects

Qualifications

• 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.

Responsibilities

• Drive overall analytical control strategy and determine critical quality attributes.
• Establish collaborations across the organization to enable analytical activities.
• Set team strategies, manage resources and define risk mitigation.
• Communicate project strategy and risks to key stakeholders.
• Act as principal contact for all stakeholders and balance cross-functional expectations.
• Participate in yearly FTE planning across the analytical organization.
• Coordinate with cross-functional teams to support regulatory submissions.

Skills

Analytical thinking

Cross-functional communication

Gene therapy

TLNP technologies

Education

Bachelor’s Degree in Science

Master’s Degree in Science/PharmD

PhD in Science

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.

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 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 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 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