- Lead a team of formulation scientists working with cross-functional R&D partners to develop therapeutic biologic candidates from early development through BLA approval.
- Provide strong functional technical leadership and ensure timely completion of all functional deliverables including reports and applicable quality and regulatory documents.
- Implement and manage functional processes and workflows for operational excellence, continually raising the performance bar for the team.
- Actively contribute to cross-functional CMC strategic discussions, ensuring drug product development plans are aligned with the team goals.
- Form strong alliances with partner functions to ensure robust and effective technology transfer transfers and control strategy implementation.
- Evaluate and recommend new technologies to enhance fundamental protein degradation understanding and formulation stabilization strategies.
- Encourage ideas and drive for continuous improvement and champion initiatives within the Drug Product R&D organization and across R&D partner functions.
- Recruit and develop top talent to create and maintain a productive team of highly skilled scientists and project leaders. Establish and maintain an environment that ensures retention of key talent through continued development opportunities and recognition of key accomplishments.
- Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.
- Ph.
- Demonstrated in-depth technical expertise in formulation and drug product process development of biologics, including process scale-up from pilot plants to commercial facilities required. Experience with combination products development and devices preferred.
- 6+ years of experience in technical leadership role that includes experience managing people with demonstrated ability to build and develop a high performing team. Must have led a team with direct responsibility to mentor and grow team members.
- Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filing.
- Understanding of industry best practices & trends to challenge status-quo and drive change.
- Self-motivated leader with exceptional influencing, partnership, and collaboration skills to solve scientific and business problems and drive results within a matrix environment.
- Knowledge of the cGMP practices and compliance requirements
- Excellent written, presentation, and verbal communication skills.
director, cmc biologics, drug product development - South San Francisco, CA , USA, United States - AbbVie, Inc
Description
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 at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job Description
Position Description:
For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to lead a diverse team of pharmaceutical development scientists supporting the development of therapeutic biologics.
He/she must be able to mentor and develop scientists across a range of different experience levels and must foster productive collaborations within the global Biologics Drug Product Development organization and with R&D cross-functional partners and across functions such as Discovery Research, Operations, Quality Assurance and Science & Technology (S&T).
ResponsibilitiesQualifications
or MS Degree with at least 10 years of related industry experience preferred or BS Degree with at least 12 years of related industry experience required.
Advanced degree in Pharmaceutical Sciences, Chemistry and/or Chemical Engineering preferred.Applicable only to applicants