MSD Associate Director_Drug Product -Operations Specialist 

India, Telangana, Hyderabad 

101650811

Job Description

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/Managecomplex 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.

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.