AbbVie

Director, ADC CMC Sciences

AbbVie$150K — $180K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree with 16+ years of CMC experience; Master's with 14+ years; PhD with 12+ years
  • CMC development experience from IND to NDA/MAA
  • Experience leading multiple CMC project teams
  • Technical knowledge of small molecule manufacturing and quality
  • Expertise in FDA and global CMC regulatory requirements
  • Proven communication and presentation skills
  • Demonstrated ability to lead and provide strategic direction

Responsibilities

  • Lead and represent the CMC team within cross-functional teams
  • Develop and maintain project plans, budgets, and timelines
  • Ensure proactive technical ownership of products and processes
  • Present technical information to management and regulatory bodies
  • Review product submissions and post-approval lifecycle management
  • Manage multiple and complex projects across development stages
  • Mentor and develop new CMC leads

Benefits

  • Paid time off including vacation, holidays, and sick leave
  • Medical, dental, and vision insurance
  • 401(k) plan for eligible employees
  • Participation in long-term incentive programs
Full Job Description
Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule products Plays a key leadership role within S&T PPG group. Responsibilities • Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews. • Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial. • Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of impact on Operations. • Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to management and regulatory agencies. • Review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer/management reviewer for submissions. • Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.) • Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing. • Develop new and less experienced CMC leads through sponsor/mentor relationships. • Identify and promote best practices among S&T CMC leads. • Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration. Qualifications • Bachelor 's Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development); Master's Degree with 14+ years of relevant experience; PhD Degree with at least 12+ years of relevant experience. • CMC development experience through IND and/or NDA/MAA. Experience leading multiple CMC project teams through IND and NDA/MAA preferred. • Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required. • Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. • Demonstrated excellence in writing, presentation, and overall communication. • Demonstrated excellence in leading CMC project teams. • Demonstrated ability to provide strategic direction for work groups, departments, etc. 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 anduntil 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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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
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ

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