AbbVie Director, Formulation Development in Lake County, Illinois
Director, Formulation Development
USA, Illinois, Lake County
2 additional locations
Research & Development
The ideal candidate will u se breadth of experience to drive best-in-class drug product development strategies to support AbbVie’s pipeline through leadership and scientific expertise for the NBE formulation development group located in Lake County.
Enable alignment for oncology drug product development across AbbVie sites. Develops and implement short and mid-term formulation and process development strategies for the NBE Pharm. Science LC function. Manage effectively organizational interfaces (Operations, Supply Chain, QA, Discovery).
Advance global candidate selection and Pre-Formulation concepts fit for purpose to the growing and diversifying discovery biologics portfolio.
Key Responsibilities Include:
Ensures alignment of NBE formulation concepts with clinical development concepts enabling seamless late stage project development and commercial transfer and launch
Provide leadership and talent development of 10-20 pharmaceutical scientists
Accountable for early and late stage scale-up activities, design space definition and technology transfers to internal and external plants
Adapting to changing environments balances priorities within own function and ensures utilization of appropriately science based approaches to ensure project and internal/external budget success and increase efficiency
Drives technological innovation and guides improvements to leverage scientific and operational excellence within NBE Formulation LC and in line with the AbbVie strategy for Biologics
Recruits, promotes and retain top talents via coaching and mentoring and assures effective succession planning. Explores and remediates strategic know how gaps related to NBE drug product development expertise
Promotes entrepreneurial thinking and makes smart business decisions while balancing risk
Proactively leads interfaces with other functions inside and outside of DPD and R&D
Assures compliance with AbbVie safety, quality and regulatory policies and government regulations
Ensures adequate support of multiple assigned CMC projects and contributes to project prioritization on a portfolio level
Proactively supports DPD Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches
Bachelor’s Degree with at least 18 years of experience with different CMC functions required; Master’s Degree with at least 16 years of relevant outstanding experience preferred; PhD Degree with at least 10 years of experience with past history of significant accomplishments to effectively manage and different functional teams with respect to science, technology, budget, resources quality, regulatory and compliance required
Proven experience in leading a biologics drug product development organization across different levels and different scientific disciplines.
Excellent technical knowledge from early to late stage biopharmaceutical development incl. formulation development, process development, manufacturing of biologic products as well asparenterals
Understands the various scientific disciplines needed in pharmaceutical development of biologics drug product (analytics, manufacturing, QA, supply chain, regulatory, combination product development)
Negotiation, conflict management, strong communication skills in fast moving environment
Evidence of multiple successful drug product leadership experiences at different stages of clinical development.
Possesses negotiating, influencing, leadership skills.
Creative in implementing entrepreneurial thinking and make smart business decisions.
- Bachelor’s Degree with at least 20 years of experience with different CMC functions required; Master’s Degree with at least 18 years of relevant outstanding experience preferred; PhD Degree with at least 12 years of experience with past history of significant accomplishments to effectively manage and different functional teams with respect to science, technology, budget, resources quality, regulatory and compliance required
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Travel: Yes, 10 % of the Time
Job Type: Experienced