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SKILLS/COMPETENCIES:

• Laboratory Experience: Extensive operational experience in a Pharmaceutical QC laboratory, specifically with Drug Substance and Drug Product processes. To be trained in and qualified for the assays that you are SME for and be able to perform investigational testing and train technicians for new methods.
• Technical Proficiency: Strong understanding of analytical technical transfer processes, compliance requirements, and troubleshooting skills. Advanced knowledge of modern methodologies; familiarity with cell cultures, advanced separation methods (cIEF, cSDS), microbiology methods, or compendial methods are a distinct advantage.
• Project Management: Demonstrated project management skills, able to effectively oversee and coordinate multiple projects, LEAN, Greenbelt certification.
  If you are passionate about contributing to the advancement of pharmaceutical science, are driven by excellence, and possess the required skills and qualifications, we invite you to apply for this exciting opportunity

Method Management: Act as the gatekeeper for the introduction of new analytical methods in the laboratory, ensuring that the scientific aspects are thoroughly assessed. Conduct feasibility experiments independently as necessary and continuously seek opportunities for method improvements in performance and execution. Oversee the entire lifecycle management of analytical methods, including their validation and verification. Furthermore, facilitate interactions with the Analytical Development (AD) team, particularly when methods transition into Quality Control (QC).

• Documentation and Compliance: As a Subject Matter Expert (SME) or delegate of QC Management, authors, reviews, and approves critical documents, including standard operating procedures. Ensure that this documentation serves as a critical component in maintaining compliance with regulatory standards for Good Manufacturing Practices (GMP). Design and create protocols related to compliant test method transfer and validation.
• Non-Conformance Investigation: You will be responsible for reviewing investigations related to non-conformances to ensure the highest quality standards are maintained. Your role will involve analyzing and interpreting data to identify discrepancies.
• Technical leadership: Apply scientific expertise to investigate and resolve complex technical issues in the laboratory. Lead investigations as a Subject Matter Expert, defining and implementing corrective and preventive actions (CAPA) alongside effectiveness checks. Furthermore, managing and documenting changes to a system, process, or product (Change Controls). You will assess the impact of the change, minimize risks, and ensure that all changes are approved, implemented, and monitored to ensure quality, safety, and compliance.
• Stakeholder management: Develop comprehensive business cases to justify the needs for new analytical equipment. Collaborate pro-actively with Analytical Development, Global QC, Local QC, and IT teams to select, purchase, and qualify new analytical equipment for QC laboratories.

Identify and seek out external resources (e.g. Parenteral Drug Association, International Society for Pharmaceutical Engineering, ) to build or enhance understanding of scientific discipline.

• Mentorship: Mentor and coach associate scientists and technicians, fostering a culture of excellence and continuous improvement within the team.
• Relationship: Reports to manager QC