Manager, Drug Product Small Molecule Contract Commercial Manufacturing
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017 and successfully launched in January of 2018. The company is also working to advance two clinical programs for AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, an oral SYK/JAK inhibitor, in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions.
The Manager position, Small Molecule Contract Commercial Manufacturing, is responsible for the established commercial and clinical manufacture of drug product (DP) to support Portola’s small molecule commercial supply chain. Primary responsibilities involve managing contract manufacturing organizations (CMOs) of drug product(s) on routine basis, support continued process verifications (CPVs) programs, managing routine commercial production campaigns including being on site at CMOs, as needed, reviewing and approving commercial manufacturing documents such as master batch record (MBR) and executive batch record (EBR), supporting the deviation investigations for operation process. Other assignments include monitoring material mass flow and inventory to support Portola global supply chain planning. The ideal candidate will have sufficient analysis skill and experience to work together with cross functions on process improvement and cost saving initiative through analysis of contributing factors and process data. This candidate will participate as an important individual contributor in the overall small molecule commercialization program at Portola.
- Monitoring of contract manufacturing organizations performing manufacture of drug product.
- Manage the routine production campaigns and assist CMOs performing the work off site and on-site.
- Work closely with cross-functional counterparts to adhere to CMO Master Quality Agreements (MQAs) or Master Service Agreements (MSAs) and/or Supply Agreements.
- Work closely with functional counterparts within and outside Portola to support continued process verifications.
- Maintains a working level of knowledge in statistic methodology and process validation.
- BS or MS in pharmaceutical sciences, pharmaceutical chemistry, pharmaceutics or chemical engineering with 5 plus years of industry experience
- Must have ability to facilitate effective cross-functional business oriented communication toward achieving project goals with international and domestic CMOs
- Must be able to communicate effectively with all levels within the company and across Portola’s CMOs
- Good verbal and written communication skills, team player, flexible to change in priorities
- Advanced knowledge of GMP production and material management system
- Extensive skill with MS Word, Excel, Visio, Power Point Presentation, and MS-Project computer programs and Lean Six-Sigma, DMAIC.
- Experience working in pharmaceutical companies within the clinical or commercial manufacturing environment