MSD Associate Director Downstream Process _Operations Specialist 

India, Telangana, Hyderabad 

951153864

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.
• Work with site support groups to assess raw materials and consumables suitability for the manufacturing process according to the defined quality standards.
• 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.

• The qualified candidate will provide expertise in the following areas, working closely with the Platform Lead DS operations:

• Change management and regulatory support planning
• Project management and External partner’s oversight
• Overseeing the production planning and inventory control
• Operational excellence and continuous improvement initiatives
• Communication and collaboration with External partners

Education Minimum Requirement:

• Bachelors or master’s 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.
• Large Scale DSP manufacturing set-up, Equipment design, commissioning, and qualifications.
• Well versed with Executional software’s, Recipe design, qualification, and execution.
• Facility Fit assessment, equipment characterizations.
• Well knowledgeable on tech transfers, CMC package support for site variation filings
• Establishing the Large-scale Chromatography column packing procedures, column packing trouble shooting.
• Establishing the mixing studies, Intermedia hold times, cleaning process design, qualification and validations.
• Well knowledge on writing/reviewing the process recipes, conducting the simulations and qualifications.
• MBR preparation/review according to the MES requirements
• Awareness on MES is desirable.
• Process Validations, Cleaning Validations (CHT, DHT), Sterilization validations, Buffer/Intermediate hold times
• DSP Process design (at a scale of 100cm chromatography column and above) and to meet comparability acceptance criteria.

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.