Rentschler Biopharma Inc.
Milford, Massachusetts, United States
(on-site)
Member Company
24 days ago
Job Type
Full-Time
Min Experience
3-5 Years
Min Education
BA/BS/Undergraduate
Required Travel
None
Salary - Type
Yearly Salary
Work Setting
Non-Lab
Job Function
Quality Control

Description

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies.  Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!  

Duties and Responsibilities

  • Processes changes of varying complexity to existing LIMS Master Data and Empower Enterprise
  • Creates new Master Data of varying technical complexity
  • Provide troubleshooting expertise and support for all LIMS and Empower activities and end users including instrument interfaces in conjunction with the IT Department
  • Interface with site personnel on integration of sample management and electronic system processes to ensure optimal laboratory operations
  • Provide hands-on, individual and group training(s) as needed for all user levels and develop training modules/protocols/work instructions accordingly
  • Update LIMS/ Empower, and corresponding departmental SOP and training materials as needed in accordance with global procedures and processes
  • Proactively reviews master data  and make changes as needed to support batch readiness
  • Adapt, improve, and modify work instructions to optimize use of Laboratory Systems (e.g., LIMS , Empower) for day-to-day processes
  • Develop understanding of manufacturing processes to provide thorough review and feedback for new material templates that are submitted by Product Development
  • Provide ad hoc reports as requested by various departments
  • Author quality system documentation such as change control, deviations, CAPAs, SOPs, work instructions

Qualifications

  • Bachelor’s Degree in STEM
  • 5+ years of relevant experience
  • Thorough knowledge of regulatory issues and the impacts on discipline
  • Experience in building Master Data in LabVantage LIMS
  • Experience in GMP environment is preferred
  • Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred
  • Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
  • Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines
  • Excellent organization and planning skills
  • Strong attention to detail and ability to adhere to standards procedures
  • Ability to drive functional, technical, and operational excellence
  • Good understanding of the complexity, interactions, and dynamics within an international company
  • Working understanding of systems and how they interact

Preferred Qualifications

  • Laboratory testing experience is highly desirable
  • Experience in creating custom fields in Empower software
  • Strong MS Excel, PowerPoint, and Word skills. Microsoft Project skills

Working Conditions

  • Normal office working conditions: computer, phone, files, fax, copier
  • Working in the laboratory environment may be required when setting up LIMS master data
  • Personal Protective Equipment must be worn as required
  • Minimum travel required

Physical Requirements

  • Frequent lifting up to 10 lbs; frequent standing/walking
  • Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods
  • PPE as required


Job ID: 73601148

Please refer to the company's website or job descriptions to learn more about them.

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