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MSD Associate Director Upstream Process_ Technical Specialist 
India, Telangana, Hyderabad 
815061523

01.09.2024

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.