Associate Director_Drug Product -Operations Specialist

Associate Director_Drug Product -Operations Specialist The External Manufacturing, Senior Specialist/Associate Director will support a technical team interfacing between our Company and External Partners (EP) in the Biologics Drug Product 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 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 Product unit operations such as Formulation, Filling, Secondary packaging, Aseptic operations and Media fills.). The candidate will be based in India report to the Platform Lead, Drug Product External Manufacturing. Responsibilities:

• 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.
• Provides a single point of technical contact to assigned External Partners, impacted our Manufacturing sites, and Commercialization.
• Provides technical oversight, management, and planning promotion for complex partnership models. Functions objectively and provides coordination, communication, and oversight of assigned External Partner technical issues.
• Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit management to assure resourcing for each activity.
• Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to standards, and ensure deliverables are technically sound.
• Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
• Develops and executes validation strategies for new and existing products.
• Provides manufacturing process sponsorship to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
• Ensures targeted communications and alignment across technical functions. Guides and coaches others in change direction
• Sponsor/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites
• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between External Partner and our Company s systems
• In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers
• Comprehends the true regulatory standards and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these standards
• Partners with External Partners to achieve business goals and to establish a common culture that benefits both our company and External Partners

Education:

• A Master s degree in Engineering or applicable Science.
• Solid experience in Drug Product vaccines and/or biologics technical operations.

Required Skills:

• Minimum of 12 years of relevant working experience in aseptic drug product manufacturing technical services (MS&T) (product presentations/ technologies, aseptic processing and microbial reduction techniques, sterile manufacturing equipment), good understanding on secondary packaging, and cold chain validations.
• Highly knowledgeable on Production operating software (Eg: SIEMENS PCS/Delta V or relevant) and capable to write/review recipes.
• Expertise and demonstrated accomplishments directing technical transfers.
• Skills in directing cross-functional teams in promotion of manufacturing operations at internal sites or External Partner(s) is preferred
• Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred
• Advanced problem-solving skills in guiding teams to resolve complex business or technical issues.
• Excellent management, partnership, change management, association, diagnostic skills, partnership, and engagement as a team player with

• Dependable association and communication skills (both verbal and written).
• Well demonstrated knowledge in Aseptic processes and simulation activities.

Preferred Skills:

• Experience with High Performance Organizational tools, Well understanding on the manufacturing digitalization, computer system validation requirements, Process Validations/Cleaning Validations and Aseptic processes.