- Interacts with multidisciplinary and multi-site groups, which may include CMOs, technology transfer teams, external vendors, and other strategic suppliers. ADs are responsible for communicating status to the CMC teams through representatives. Once the product is licensed by the regulatory authorities, the responsibility for commercial manufacturing transitions to another organization within AstraZeneca.
- Participates in drug product technology transfer teams when AZ Biologics is working with CMOs.
- Collaborates with Engineering, Supplier Quality, and other functions to ensure that appropriate equipment is qualified and available for manufacturing and device assembly if appropriate.
- Facilitates alignment of Development and Operations technical decisions necessary through completion of Process Validation to ensure commercial viability of the manufacturing process.
- Assists with device manufacturers for commercial product.
- May participate in vendor visits of potential drug product and device companies.
- Communicates pertinent information to appropriate representatives to ensure successful product transfer and commercialization.
- Assists to develop long term drug product manufacturing strategies in conjunction with Operations, BioProcess Development, and others.
- Reviews and approves site and supplier changes to materials/specifications
- Responsible for technology transfer of device technology as receiving group for biologics operations;
- Provides commercial operations support during lifecycle for process improvement and revalidation of transfers.
- Develops and transfers robust processes to internal or external manufacturing sites
- Provides review and oversite of capital equipment spends associated with commercial scale-up purchases. Influence decisions at sites in respect to investments and asset utilization
- Provides support for regulatory submission documentation as required
- BS degree in Engineering, Life Sciences or similar field
- 20+ years of industry experience
- Greater than 10 years’ experience in a biotech/pharmaceutical company.
- 5+ years of direct experience with biologics drug product manufacturing, technical support of drug product manufacturing or drug product development experience with some oversight of manufacturing
- The candidate will have a broad based understanding of Operations including Manufacturing Operations, Supply Chain, Quality Assurance, and Quality Control.
- Excellent communication skills with the ability to work optimally in cross functional teams and effectively influence team members.
- Ability to travel at least 25% of the time; Typically within supported region, but occasionally global (US/Europe/Asia)
- MS degree or PhD in Engineering, Life Sciences or similar field preferred
- 17+ years with MS Degree
- 10+ years with Ph.D. Degree in Engineering or life sciences
- Statistical analysis experience a plus
- Experience commercializing a biological combination product is a plus
- Experience support functional testing of devices and/or device complaints evaluation is desired.