Related tasks:

• Participation in CMO/vendor selection with Procurement, Quality, and other business functions.
• Technical single point of contact and BMS Site Implementation Lead to contract manufacturing organizations in support of technical transfers. This includes review and approval of site technology documents such as Engineering Studies, characterization Protocols, Validation Protocols, Process Risk assessments, etc. This likely will include Person in Plant (PIP) support.
• Execution of Process Owner Role at contract manufacturing sites. This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO , identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews and to support generation of Annual Product Quality Review documents for commercial products.
• Leadership or support of critical manufacturing or complaint investigations that involve significant product impact including root cause analysis, CAPA generation, and impact assessment.
• Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
• Participation on matrixed Technical Product Teams to drive technical process improvement strategies. Must generate presentations to support development, approval, and execution of technical plans.
• Employment of resources and processes (OPEX etc) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.

• A bachelor’s degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Masters or PhD level degree is strongly preferred.
• Subject matter expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes.
• Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
• Demonstrated experience with the execution of Technology Transfer and scale up programs for commercial drug product manufacturing processes.
• Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
• Ability to work within and lead cross-functional technical teams, across multiple cultures.
• Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ).
• Statistical analysis capability, including use of statistical software platforms (e.g. Minitab, JMP) to determine trends and variability across inter-batch data sets. Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.