Abdul Wajid Abdulwajid
Sr. Director of Vaccine Process & Manufacturing Sciences Agenus inc. USA
- Seventeen (17) years of management experience in all facets of biologics development & manufacturing in leadership positions that include Vaccine
- Extensive expertise in cell line development, media development, purification development, analytical development & formulation development, clinical manufacturing and commercial manufacturing.
- Directly responsible for the successful transfer of late phase III manufacturing processes for BDS at CMO and its implementation and production at 2500L scale.
- Completed and demonstrated the comparability of BDS produced at XOMA and at CMO
- Member of CMO selection committee for manufacturing of phase III antibodies
- Extensive experience in process development and manufacturing of antibodies using CHO-K1 & E.coli.
- Directed process characterization of multiple antibodies based on QRM, DOE and QbD processes for upstream and downstream processes.
- Reviewed and approved process validation protocols and reports for PPQ BDS batches
- Provided technical support to CMOs in resolving and closing the process deviations.
- Planned and implemented stage III Continued Process Verification (CPV) protocols for trending and monitoring CPP, CQA,APRs & Product Quality Reviews(PQRs)
- Scaled up Pertussis combo vaccine commercial process to 2000L; significantly contributed to the approval PLA for combo commercial vaccine.
- Develop and maintained knowledge management systems for commercial processes in the form of TDRS and TTRs
- Involved in writing of CMC sections of INDs (phase I, II, III), PLA and BLA for proteins, vaccines and antibody products.
- Worked collaboratively within matrix organization structures with Preclinical, Clinical, Regulatory, Quality and Supply chain to support clinical and commercial manufacturing.
Ability to coach and develop the technical skills required by process development and manufacturing personnel with focus on right priorities, good project management skills, and negotiation skills