Scientist, Parenteral Exm Ms&t
vor 6 Monaten
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Position Purpose**
- Provides technical support to the External Manufacturing Organization (ExM) for manufacturing of Parenterals at Contract Manufacturing Organizations (CMO's) as individual contributor
- Single point of contact for technical matters for the a particular brand/line at the CMO, and perform Person in Plant duties (PIP) in support of technical transfer and commercial manufacturing activities.
- Ensure the transfer of robust manufacturing processes to CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO.
- Ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX) principles, to reduce supply risks.
**Key Responsibilities**
- Supporting CMO/vendor selection with Procurement, Quality, and other business functions: preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs)
- Managing or supporting technology transfers to CMOs
- 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. This includes Person in Plant (PIP) support
- Execution of Process Owner Role at a single contract manufacturing site for a single product and line. 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. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews, to support generation of Annual Product Quality Review documents for commercial products and to ensure compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvement
- Provide technical guidance in the understanding of root cause analysis, impact assessment and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for DP manufcaturing.
- Technical input, and/or authoring, of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
- Participation on various matrixed teams to drive technical process improvement strategies.
- Driving the use of strategies, 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.
- Support operational management of CMO as per Virtual Plant Team (VPT) governance structure
- Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.
- Assits and/or leads moderately complex technical projects and life cycle project activities at CMOs.
- Assits and/or leads and coordinates change requests and process deviations.
- Collect, maintain data for process robustness analysis to support life cycle activities at CMO’s
**Key Competencies**
- Thorough understanding in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes.
- Understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing, Environmental Health and Safety (EHS)) aspects of drug product (DP) manufacturing.
- Demonstrates ability in 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.
- Demonstrated ability in negotiating and influencing without authority in complex, high impact situations.
- Presentation and communication skills, both oral and written.
- Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a reg
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