Associate Director / Director, Pharmaceutical Development, CMC Biologics

Employer
AbbVie
Location
Redwood City, CA, US
Posted
Sep 08, 2019
Ref
1905002
Required Education
Doctorate/PHD/MD
Position Type
Full time
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica®, Venclexta™, and Empliciti™ and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. AbbVie is also expanding their expertise through partnering with companies leading the way in emerging biologic technologies including oncolytic virus' and CAR-T cells.

Currently, we have an exciting opportunity available at the Associate Director / Director level in the Pharmaceutical Development Group within the CMC Biologics department at our Redwood City location. As part of our team, your key responsibility will be to provide strong technical leadership to the Formulation Group, driving drug product development for our oncology pipeline through clinical proof-of-concept.

Key responsibilities:
  • Drive the development of preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes for early-stage oncology programs through clinical proof-of-concept.
  • Implement and manage work flows within the Formulation Group for improved efficiency, resource optimization, and seamless transition of drug product activities across internal and external CMC interfaces.
  • Provide technical leadership and drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development and raise visibility within the scientific community through external presentations and publications.
  • Actively participate in cross-functional CMC teams, ensuring drug product development is aligned with the team goals. May lead cross-functional CMC teams and represent CMC function on AbbVie Asset Development Teams.
  • Actively interact with CMC members and other AbbVie stake holders to enable successful development of AbbVie drug products. May lead cross-site drug product initiatives across the global AbbVie organization.


EDUCATION and/or EXPERIENCE
  • PhD and 8+ years of relevant industry experience OR Masters degree and 15 years of relevant industry experience OR Bachelors degree and 20 years of relevant industry experience.
  • 8+ years of experience in technical leadership role that includes experience managing and mentoring people.
  • Demonstrated technical and leadership experience in leading formulation and drug product process development of broad range of biologics through various stages of clinical development required. Experience encompassing early and late-stage drug product development preferred.
  • Strong understanding of protein/macromolecule characterization, biologic drug structure-function relationship, and degradation pathways, and regulatory requirements to guide development of complex protein constructs.
  • Prior experience leading cross-functional CMC and teams and working with external partners highly desirable.
  • Excellent communication skills required.