Director II NBE (New Biological Entity) Author

Company Description

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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

Job Description

The Director II NBE Author leads the development and oversight of Chemistry, Manufacturing, and Controls (CMC) dossier strategy and authoring to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. Responsibilities include working with the CMC project team and external stakeholders to develop cutting-edge control strategies and influencing the generation of data packages that support the CMC control strategy. The Director II oversees a team of authors that write the narrative sections of CTDs to communicate a single, integrated strategy to health authorities, contributes to the preparation of regulatory query responses and briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content. The Director II also partners with functional leads to create AbbVie best practices and influences across internal and external stakeholders to address emerging module 3 topics

Responsibilities

• Leads a team of Dossier Leads and Dossier Authors with ultimate accountability for the creation of high-quality submission content by establishing best practices, coaching and mentoring.
• Conducting management reviews for INDs, IMPDs, NDAs and BLAs to ensure clear and consistent messaging of the control strategy across the filing.
• Participates in CMC Governance meetings to provide expert guidance in the creation of data sets for high quality submissions, real-time perspectives on regulatory expectations on data packages, and risk identification and mitigation strategies.
• Skilled in influencing diverse teams with varying priorities and working styles to achieve project goals.
• Independently identifies opportunities for improvement of departmental work processes and manages large and small cross-functional process improvement projects. Contributes to the definition of departmental vision and strategy. Converts goals to tasks and coordinates activities to meet goals. Lead multiple process improvement teams through execution on defined objectives and keep management informed of progress and achieved project milestones.
• Develop and provide advanced training courses, presentations, and guidance to foster best practices.
• Establish and maintain strong network across R&D stakeholders. Utilize established organizational network to identify opportunities, gaps and synergies consistent with departmental strategy. Effectively influences senior leaders regarding project initiatives and direction.
• Builds industry network to influence and stay abreast of emerging CMC development best practices.
  
  
  

Actively manages departmental team and establishes high performing teams. Defines performance expectations and holds team accountable for progress against plans, processes, and practices to determine effectiveness and areas for process improvement

Qualifications

*This position will be required to sit on-site 3 days / week*

• Bachelors with 18, Masters with 16, or PhD with 10 years of CMC functional experience including late-stage development experience .
• Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation, etc.)
• Deep knowledge of CMC development of biologics. Preferred experience in the development of commercial CMC control strategies.
• Experience in organizational leadership, leading teams of scientists, and mentoring talent
  
  
  

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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
  
  
  

Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys 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 AbbVies 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, visithttps://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

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 AbbVies 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, visithttps://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