MSD Associate Director Downstream Process_ Technical Specialist 

India, Telangana, Hyderabad 

436321595

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 Downstream Process, Large Scale Chromatography systems/Columns, Mixing Vessels and UF/DF systems.
• Demonstrated experience on scale-up, process design and tech transfer activities in large scale DSP manufacturing (preferably Chromatography column operations of 1 meter and above).
• Design a process according to the facility fit and equipment fit with minimal changes.
• Great understanding and Establishing of Mixing studies, Intermediate hold times, TFF Cassettes/Resin lifetime establishment, simulation studies, designing protocols and etc.
• Supporting of commercial process trouble shooting and investigation 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 facility set up.
• Establishing the Buffer and product intermediate hold times.
• Establishing the comparability limits and design a process to be within comparability.
• Support to design and establish Annual Product Quality Reports and CPVs.
• 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

Not Applicable

*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.