Scientist - Parenteral Exm Ms&t
vor 1 Woche
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
**Job** **Function**
Scientist - Parenteral ExM MS&T will provide technical support for manufacturing of Parenterals at Contract Manufacturing Organizations (CMO's) in the US, EU, and abroad. The individual will act as single point of contact for technical matters at the CMO and may perform Person in Plant duties (PIP) in support of technical transfer and commercial manufacturing activities.
This position will report into the Associate Director, Parenteral ExM MS&T located in Boudry, Switzerland.
**Responsibilities**
- 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.
**Required** **Competencies**
- Strong strategic and analytical thinking, problem solving and rapid decision-making skills.
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment.
- Strong ability in negotiating and influencing without authority in complex, high impact situations.
- Strong presentation and communication skills, both oral and written.
- International travel is required.
- 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 manufacturing processes of parenterals.
- Strong technical writing skills.
- Demonstrated strong oral and written communication skill s, 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) consistent with current Global Health Authority requirements.
- Statistical analysis capability, including use of statistical software platforms (e.g. Minitab, J M P) 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.
- Requires approximately 30-50% travel, mostly to CMO sites. May require Person in Plant (PIP) temporary assignments, where location at site is up to 75% for a temporary time period
- Strong technical knowledge of sterile manufacturing technology and processing techniques.
- Demonstrated ability to:
- influence areas not under direct control to achieve objectives
- work strategically, manage multiple programs consistent with department objectives.
- work well in a matrix environment and effectively support the decentralized manufacturing function.
- build alignment with business partners including Procurement, Quality, and CMO stakeholders.
- manage risk and make rapid decisions.
**Required** **Qualification(s)
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