Senior Specialist, Downstream Process _Operations

The External Manufacturing, senior specialist 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.

The Specialist (Biologics External Manufacturing) will provide operational 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.

• 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 8 -10 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.