Job Description
Primary Activities will include:
- Reports to the platform lead (or delegate) and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues.
- Supports facility start-up and technical transfers and/or provide global technical operations support for continuous commercial manufacturing at an External Partner.
- Provides on-going support to External Partners to resolve manufacturing issues, proactive analysis of process performance and develops plans to meet capacity needs.
- Collaborates with Biologics Quality Operations and others on the Focused Factory to support the product lifecycle.
- Supports validation strategies for new and existing products.
- Provides a 'calibrated' technical review of External Partners’ process change requests, deviations, protocols, and Master Batch Record changes.
- Troubleshoot manufacturing issues and support investigations through scientific problem-solving approaches.
- Understands regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
- Based on calibrated oversight model, minimizes duplication of efforts between External Partner and our Company’s systems.
- Partners with External Partner to achieve business goals and to establish a common culture that benefits both our Company and the External Partner.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Education Minimum Requirement:
- Bachelors or Masters or Equivalent in chemical/biochemical engineering, biotechnology, pharmaceutical science, life sciences
Required Experience and Skills:
- Proven experience in highly regulated certified manufacturing plants with a minimum of 12 yrs. experience in the areas of cell banking, Cell Culture manufacturing process, technical transfer, process validation, or have demonstrated experience in these areas.
- Demonstrated experience on scale-up, process design and tech transfer activities in cell culture large scale manufacturing (preferably 10kL and above)
- Design a process according to the facility fit and equipment fit with minimal changes.
- Great understanding and designing of the gassing strategies, simulation studies, designing protocols etc.
- Supporting of commercial process trouble shooting, investigations support
- Designing of a cleaning process, cleaning validations, dirty equipment hold times establishment, clean equipment hold times, establishing the carry over limits in multiproduct manufacturing set up.
- Establishing the media and product intermediate hold times.
- Perfusion technologies
- Establishing the comparability limits, and design a process to be within comparability.
- Support to design and establish Annual Product Quality Reports
- Proven experience in highly regulated certified manufacturing plants.
- Campaign reviews and product life cycle management
- Establishing the CPV limits and ensuring the process compliance within CPV.
Preferred Experience and Skills:
- Experience with High Performance Organizational tools, Well understanding on the manufacturing digitalization, computer system validation requirements, Process Validations/Cleaning Validations.
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.