Mark Lankford
Scientific Leader at GSK
- Role
- Scientific Leader at GSK
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Mark Lankford
Experienced leader in Biopharm CMC with 5+ years of team management experience and 10+ years of matrix team leadership focused on building and developing value-driven process development teams.> Process Development, Characterization and Validation> Quality by Design (QbD) Principles as governed by ICH Q8, Q9, and Q10> Control Strategy and Technical Risk Assessments (TRA)> IND and BLA/MAA authoring> Tech Transfer leadership> Stakeholder management and effective communication in matrixed team environments> Team and Performance Management of 5+ direct reportsProcess Development & Validation | Quality by Design | Team Management | GMP & GxP | Technology Transfer | IND, IMPD, BLA, MAA | Project Management
Experience
Scientific Leader
May 2021 — Present
Team Management (5+ direct reports) and Matrix Team Leadership within large molecule drug substance process development, technology transfer and project planning for a late-phase/second-generation assets- Departmental lead for Quality by Design (QbD) strategy implementation embedding ICH principles into guidance and strategy principles for project teams | External engagement with industry consortia on innovative QbD approaches and best practices- Clinical (IND) and commercial (BLA/MAA) regulatory file authoring and reviewing experience
Education
University of Pittsburgh Swanson School of Engineering
Bachelor of Science, Chemical Engineering
2006 — 2010
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