Director, CMC Sciences - 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Lead global technical support for a commercial biotherapeutic product. Support global regulatory submissions by serving as the key point of contact for Module 3 content and responses to health authority information requests.  Develop strategies to ensure successful product launches, process improvements, and drug substance tech transfers.

Responsibilities:

• Lead cross-functional CMC team(s) in authoring sections of regulatory documents, including INDs and BLAs, based on relevant source documentation.
• Lead Operations-wide Product Performance Teams (PPT) to ensure successful commercial lifecycle management.
• Drive alignment with key business stakeholders including Development Sciences, Quality Assurance, Regulatory Affairs and others at the Director and VP level
• Collaborate with external partners and/or Abbvie manufacturing sites to drive key development or assurance of supply projects forward
• Contribute on program acceleration and increased efficiency initiatives.
• Drive cross-functional resolution of CMC investigations or GMP manufacturing issues
• Represent Product Development Science and Technology (PDS&T) at key governance reviews
• Accurately project resource needs and ensure adherence to local and corporate budgets
• Optionally, supervise direct reports who contribute to team deliverables or independently lead other CMC projects

• BS or equivalent education in Biology, Biochemistry, Engineering or related discipline and 15+ years of experience in the biopharmaceutical industry; MS and 12+ years experience; PhD and 10+ years experience.
• Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development.
• Demonstrated knowledge of Good Documentation Practices (GDP) and technical writing.
• Demonstrated knowledge of scientific and regulatory requirements for biopharmaceutical products.
• High proficiency with Microsoft Word and Excel.
• Proficiency with Minitab, JMP or other statistics software

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 short-term incentive programs. ​

• 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, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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