Associate Director, Downstream Process

Job Description

The External ManufacturingAssociate Director will support a technical team interfacing between our Company and External Partners (EP) in the Biologics Drug substance manufacturing area. This individual will support the platform lead(s) in the execution of technical transfers to and from External Partners through process validation completion and/or provide global technical operations support for continuous commercial manufacturing at an External Partner and this individual will have to work from Hyderabad site operations.

The Specialist (Biologics External Manufacturing) will provide technical support to the platform lead and to the Focused Factory. Key elements of this role include supporting team/partner interactions proactive analysis of process performance supporting change management deviations/investigations resolution of production issues regulatory filing support and supporting continuous improvement initiatives with partners. The ideal candidate will be able to travel to domestic partner sites to effectively manage the partnership and associated activities and will also have effective communication skills and tools for remote support to the partnerships/virtual sites. Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing technology validation engineering quality analytical drug substance unit operations such as downstream/purification processes Viral clearance studies/validations and establishing the cold chain processes).

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 Companys 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.

Required Skills:

Preferred Skills:

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