Leitet ein Team von Operational Support Scientists und sorgt für regelkonforme und effiziente Produktionsabläufe in der Filling Line II.
Responsibilities
Führung, Coaching und Weiterentwicklung eines Teams von Operational Support Scientists
Steuerung und Sicherstellung der effektiven Umsetzung zentraler Compliance-Prozesse
Bereitstellung operativer Qualitäts- und Compliance-Unterstützung
Funktion als Subject Matter Expert für Deviation- und Change-Management-Prozesse
Sicherstellung der fristgerechten Prüfung, Genehmigung und Bearbeitung von Abweichungen, CAPAs, Änderungsanträgen
Requirements
Bachelor- oder Masterstudium in Life Sciences, Biotechnologie, Pharmazie, Ingenieurwissenschaften, Chemie oder vergleichbare naturwissenschaftliche Fachrichtung
Senior Specialist QA to provide proactive, real‑time quality assurance support within manufacturing operations at Johnson & Johnson Innovative Medicine in Leiden, Netherlands.
Compensation
The anticipated base pay range for this position is: €64 500,00 - €104 535,00
Responsibilities
Maintain an active QA presence in manufacturing areas during assigned shifts
Observe critical GMP and aseptic operations and provide real‑time quality guidance
Conduct routine floor walks, GMP observations, and GEMBA activities
Supervise compliance with procedures, data integrity principles, contamination control requirements, and cleanroom behaviors
Provide quality oversight for critical process steps and witnessing activities within the site Process Confirmation Program
Requirements
Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences, or another relevant scientific field
The Supervisor, Production is responsible for all aspects of a specific business unit within the Liquid Dose Production facility, including ensuring that all work is performed in compliance with Safe Work Practices, cGMP, Standard Operating Procedures, and company policies.
Compensation
The hiring range for this position is $83,958.00 - $139,930.00 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
Responsibilities
Provide results oriented leadership that drives continuous improvement consistent with the Operations Business Objectives
Co-ordinate, assign and supervise all production activities and outcomes for area of responsibility to ensure production schedule/agreed upon goals and objectives are met
Use systems and metrics to guide the initiation and execution of safety, quality, productivity and continuous improvement initiatives in support of the Operations Business Objectives
Provide strong leadership to the team that fosters personal development, interaction and participation, including coaching and administration of the Apotex Compatibility Process where necessary
Provide leadership as a member of the Production leadership team, building and maintaining positive relationships with the key business partners within and outside of Production
Requirements
Post-Secondary Diploma or Degree in Pharmaceutical Sciences, Engineering or related field
Nice to have: Previous experience in the Food, Consumer Packaged Goods or Pharmaceutical industry
Provide leadership and oversight for manufacturing operations within Cell Therapy while ensuring a safe, compliant, and efficient production environment.
Compensation
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
Responsibilities
Provide a safe, controlled work environment and ensure site safety objectives are communicated and understood by all manufacturing personnel.
Lead manufacturing teams and serve as the subject matter expert for assigned operations, including areas such as Cell Growth, Drug Product Filling, and related manufacturing processes.
Provide in-suite oversight during critical manufacturing activities such as harvest, vial filling, visual inspection, and other key production operations.
Support technical transfer activities, including process execution, methods transfer, engineering runs, training runs, water runs, and qualification activities.
Collaborate with Quality Assurance and cross-functional teams to establish procedures, quality systems, and manufacturing strategies for new and existing programs.
Requirements
Bachelor’s degree
Nice to have: automated drug product filling systems
Nice to have: RABS
Nice to have: isolator technology
Nice to have: automated or manual visual inspection systems
Lead and own process and equipment systems across the full lifecycle, providing technical leadership, design reviews, vendor coordination, and ensuring compliance with GxP and regulatory requirements.
Compensation
The expected base salary range for this position at hiring is $135,000 - $160,000. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Responsibilities
Own assigned process and equipment systems across the full lifecycle
Translate process, product, regulatory, operational, maintenance, and safety needs into user requirements, technical specifications, system risk assessments, design criteria, and acceptance requirements
Provide technical leadership and documented owner input during process, equipment, piping, automation, facility-interface, constructability, operability, maintainability, contamination-control, and safety reviews
Coordinate technical interfaces among internal functions, A/E partners, equipment vendors, integrators, and construction/CQV teams
Plan and support vendor document reviews, FAT, SAT, commissioning, troubleshooting, qualification, punch-list resolution, turnover, and package closeout
Requirements
Bachelor’s degree in an Engineering or Science discipline
Nice to have: technical experience with plasma or biological-material thawing
Nice to have: container opening
Nice to have: liquid pooling and transfer
Nice to have: automated material handling/robotics
QA Manufacturing SpecialistNewten23 health AG · Visp, Switzerland
Supervisor, ProductionNewApotex · Richmond Hill, Canada
QA ProfessionalNewNovo Nordisk A/S · Koriyama, Japan