Intern - Parenteral Exm Ms&t
vor 3 Wochen
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**
Intern - Parenteral ExM MS&T provides technical support for manufacturing of BMS biologic at Contract Manufacturing Organizations (CMO's) in the US, EU, and abroad. The individual will support the 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.
**Responsibilities**
- Supports CMO/vendor selection with Procurement, Quality, and other business functions.
- Supports the technical single point of contact and BMS Site Implementation Lead to contract manufacturing organizations in support of technical transfers. This includes drafting and review of site technology documents such as Engineering Studies, characterization Protocols, Validation Protocols, Process Risk assessments, etc. This likely will include traveling to CMOs.
- Support of the Process Owner at contract manufacturing sites. This includes drafting and review of process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO, proposals for process robustness improvement projects. Use of this knowledge to support and improve timely, comprehensive and accurate process data reviews and to support generation of Annual Product Quality Review documents for commercial products.
- Support of critical manufacturing or complaint investigations that involve significant product impact including root cause analysis, CAPA generation, and impact assessment.
- Technical input review of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
- Participation on matrixed Technical Product Teams to support technical process improvement strategies. Drafting of 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**
- Demonstrated strong oral and written communication skills.
- Ability to work within and cross-functional technical teams, across multiple cultures.
- 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.
- Understanding of sterile manufacturing processes, with knowledge of related to the design and control of these processes.
- Understanding of concept of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
- Basic technical writing skills.
- Understanding of formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone.
- Requires approximately 5-10% travel, mostly to CMO sites.
**Required** **Qualification(s)** and **Desired** **Experience**
- Technical knowledge of pharmaceutical-/bio-technology.
- Minimum 2 years of relevant academic experience and knowledge in engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, micro-/biology or a related pharmaceutical/natural/engineering science).
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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