AbbVie

Director, PDS&T Analytical CMC Development

AbbVie • $130K — $180K *
Worcester, MA 01604In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a Science related field with extensive related work experience; or a Master’s Degree with significant experience; or a PhD with a minimum of 10 years experience.
  • Experience in a research or development environment.
  • Proven track record of innovation and successful product releases.
  • Strong interpersonal skills and ability to collaborate with diverse teams.
  • Demonstrated ability to influence across various scientific disciplines.
  • Technical experience in healthcare, diagnostics, medical devices, or pharmaceuticals.

Responsibilities

  • Drive the analytical control strategy for biologics, including specifications and critical quality attributes assessment.
  • Establish cross-organizational collaborations to enable crucial analytical BLA activities.
  • Set team strategies, manage resources, and define risk mitigation strategies.
  • Communicate project strategies, key issues, and risks to relevant teams and manage resolutions across functions.
  • Serve as the principal contact for stakeholders, balancing conflicting expectations between functions.
  • Participate in annual FTE planning across the analytical organization.

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees.
  • Participation in long-term incentive programs.
Full Job Description
Job Description

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 escalate 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


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.


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 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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

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Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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