Principal Scientist Exm
vor 3 Wochen
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
**Description**
This position will report into the Associate Director of Parenteral ExM MS&T and will be located at the BMS Office Boudry, Switzerland.
**Key responsibilities include**:
- Provide technical support and leadership to the External Manufacturing Organization (ExM) for manufacturing of Parenterals at Contract Manufacturing Organizations (CMO's).
- 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.
- 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), etc to reduce supply risks.
- 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.
- Maintain current knowledge of technology to support successful operation of the ExM business unit.
- 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 Request for Proposal (RFPs).
- Execution of Process Owner Role at contract manufacturing site for a single or multiple products. 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 provide technical support to ensure compliance and security of supply - metrics review, investigation close-out, change control review, Annual Product Quality Review reviews and continuous improvement.
- Leadership or support 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 manufacturing. Leads and coordinates change requests, sometimes across sites or functions.
- Technical input, authoring, and approval 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.
- 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.
- Coordinating and leading of moderate or high complexity technical projects and life cycle activities at CMOs or across departments.
- Where appropriate, engage with brand teams and ExM business units to raise awareness and manage/mitigate risks to product supply, supporting the identification of continuous improvement and business continuity projects.
**Qualifications**
- Bachelor degree with 9 -12 years of relevant experience.
- Masters (6-9 years’ experience) and Ph.D. (4-6 years’ experience) is preferred but not required.
**Required Skills and Experience**:
- Advanced knowledge in sterile drug product manufacturing (liquids, lyophilized products, suspensions, small and large molecules).
- The role holder will have in depth understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP)), Environmental Health and Safety (EHS) aspects of drug product (DP) manufacturing, validation, quality systems, equipment innovations, upgrades, and instrumentation. Ability to work on own and as part of a team and to drive issues to resolution.
- Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.
- Experienced in statistical process analysis, including use of statistical software platforms (e.g. M
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