Overview
Generalist Medical Lab Scientist/Technician (FT, Rotating) – Center City Jobs in Philadelphia, PA at Thomas Jefferson University and Hospitals
locations
Milford, MA, United States
time type
Vollzeit
posted on
Heute ausgeschrieben
job requisition id
JR2138
Rentschler Biopharma ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene Beratungsleistungen einschließlich Projektplanung und regulatorischer Unterstützung an. In Stevenage, UK, haben wir das auf Zell- und Gentherapie spezialisierte Unternehmen Rentschler ATMP Ltd. gegründet.
Wir sind ein Familienunternehmen mit rund 1.400 Mitarbeiter/-innen aus 25 Nationen. Was uns bei Rentschler Biopharma vereint, ist die Leidenschaft für das, was wir tun. Wir versetzen unsere Partner in die Lage, Patienten mit schweren oder seltenen Erkrankungen zu helfen.
Mit unserer Hingabe und unserem Wissen wandeln wir medizinische Forschung in ausgezeichnete Biopharmazeutika um. So leisten wir einen entscheidenden Beitrag zur weltweiten Verfügbarkeit essenzieller Therapien. Um unser langfristiges und nachhaltiges Wachstum zu sichern, bauen wir unser Team weiter aus. Werden Sie Teil unseres einzigartigen Teams und gestalten Sie mit uns gemeinsam die Zukunft der Biopharma-Branche!
Duties and Responsibilities
Primary QC contact for the complete analytical methods portfolio and link between project team, international customers as well as internal and external laboratories
Representative of the QC labs as well as Rentschler quality standards in assigned client projects; working in collaboration with all QC departments (AD, Microbiology, Raw Materials, and Release) and potentially Process Development Analytics to gather information to present to client and providing client feedback and requests back to the appropriate departments
Determines client needs for requested work packages and collaborate internally to assess capabilities/capacity
Prepare for client facing meetings by consulting SMEs, reviewing work package data, and generating presentations as appropriate
Project planning of analytical work packages including method developments, qualifications, validations, specification development, sampling plans
Assess new projects as it relates to QC activities and capabilities
Coordination of analytical support and timelines between development, production, and QC departments
Organizational and technical support of analytical method developments in the context of projects Initiate and own change controls related to client request for SOPs, Specification Documents, Scope of Analytical Methods
Inter-laboratory compilation, evaluation and documentation of various analytical data as well as collaboration in the lifecycle management of analytical methods as it relates to assigned projects
Provide collaboration and potential authoring SOP’s, lab investigations, OOS Investigations, and deviations as it relates to assigned projects
Escalation of quality critical issues in customer projects within the Rentschler Quality Unit
Review/Collaboration of development, validation, and Qualification of analytical methods per ICH USP guidelines
Continuous research for new methods/techniques as well as initiation and organization of laboratory testing
Ensure department readiness for audits by both internal and external authorities; potential contact person for analytical laboratories during both internal and external inspections
Qualifications
Masters Degree in field of biochemistry, biotechnology or comparable field with at least 5+ years of experience in Analytical Process Sciences, Analytical Development, and/or project management in a Pharmaceutical, Biotechnology, CDMO, or other healthcare related field.
OR
Bachelors Degree with 7+ years of experience in Analytical Process Sciences, Analytical Development, and/or project management in a Pharmaceutical, Biotechnology, CDMO, or other healthcare related field
Solid experience in common biological and protein chemical analytical methods
Knowledge of GMP-compliant analytics
Strong Understanding of GMP’s with expectations of a commercial GMP environment
Must communicate effectively (verbal and written) with director and peers; written communicate skills require full competence in following detailed written instructions, creating/revising SOP’s and reports
Advanced knowledge development, approval, manufacturing and testing of biopharmaceuticals
Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint and Project
Working Conditions
May require working in laboratory environment including using chemical reagents and analytical equipment
Personal Protective Equipment must be worn as required
Normal office working conditions: computer, phone, files, fax, copier
Will interact with other people and clients
Pace may be fast and job completion demands may be high
Physical Requirements
Frequent lifting up to 10 lbs
Frequent standing/walking to work in lab environment for extended periods
Frequent sitting for extended periods to use computer
Brauchen Sie Hilfe?
Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team:
[email protected]
Title: Generalist Medical Lab Scientist/Technician (FT, Rotating) – Center City
Company: Thomas Jefferson University and Hospitals
Location: Philadelphia, PA
