About
Biotech company seeking a technical operations consultant to drive project management at their new state of the art GMP manufacturing facility. This individual will use his/her technical knowledge and expertise to assist and guide functions in the development, prioritization and tracking of activities required for successful implementation of process/analytical validation, production of registration batches, risk assessments, and associated activities leading to commercial manufacturing for product launch and global commercial introduction
Responsibilities
- Conduct on-going gap assessments to determine potential technical tasks/services needed to stay on schedule for early commercialization including new API facility completion, CMO contracting for finished sterile drug product, labeling, packaging, distribution/storage.
- Provide consultancy and guidance to technical functional heads and senior management on project challenges and mitigation solutions.
Ideal Candidate
Skills
Functional Areas
Manufacturing (Drug/Device/Biologics)
Therapeutic Areas
multiple
Product Technologies
oligonucleotides
Development Phases
III/Pivotal
IV/Post-approval
Regulatory Pathways
NDA
Qualifications
Education
- BS (Bachelor of Science)