Manager - Materials Process & Delivery

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Job Description

Job Description: MPD Materials Process/Packaging Delivery - PS - Band 1

Job Family Summary:

The job family for this role includes a collection of jobs related to the process and delivery of materials and packaging in the MPD sector. This includes managing resources, coordinating with various teams, and ensuring timely delivery.

Job Description:

This role is part of the MPD Materials Process/Packaging Delivery team. The primary responsibility is to support and assist in executing strategies within the team and organization. The role involves participation in the development and implementation of new ideas, techniques, procedures, services, or products under guidance.

Key Responsibilities:

Responsible for process development (scale up to commercial scale), Technology transfers, New vendor qualification for India/ AMA region for development of highly regulated markets with focus on quality, safety, regulatory compliance, cost effectiveness and operational feasibility. Lead process development from brief definition through to improving manufacture at scale on innovation, renovation and operational (cost savings, quality, complexity reduction) projects, by following best practices. Define, Develop & validate the cleaning & Sanitization Procedures Create, Review, Approve of all the technical documents (Validation protocols, trial reports) in digital system. To actively work and support all the saving projects related to process & materials. Provide training to the cross functional teams and CMO's for imparting training of products, process, technical standards…etc. Responsible for providing expert technical support for the development, troubleshooting of raw materials, Investigation related Out of Specification of finished product/stability failures…etc. Strong communication/regular updates on project status with key stakeholders - QA, Operations, regulatory function

Qualifications:

Technical Skills:

• Hands-on experience in product technology transfers, process development (lab scale to commercial scale) of oral solid dosage/soft gels
• New Vendor development (materials or products)
• Hands-on experience in defining, developing & validating the cleaning & sanitization procedures.
• Experience in handling regulatory audits – USFDA, MHRA, ANVISA
• Experience in equipment (used in oral solid dosage /soft gels) & area qualifications.
• Hands on experience in creating developing, reviewing & approving various documents -specifications, validation protocols. reports as latest regulatory requirements/guidelines
• Hands-on experience in product technology transfers, process development (lab scale to commercial scale) of oral solid dosage/soft gels
• New Vendor development (materials or products)
• Hands-on experience in defining, developing & validating the cleaning & sanitization procedures.
• Experience in handling regulatory audits – USFDA, MHRA, ANVISA
• Experience in equipment (used in oral solid dosage /soft gels) & area qualifications.
• Hands on experience in creating developing, reviewing & approving various documents -specifications, validation protocols. reports as latest regulatory requirements/guidelines
• Good understanding of latest cGMP guidelines, different market regulatory requirements with respect to product categories (drug/food/nutraceuticals )

Soft Skills

• Collaboration-Build leverage strong relationships across functions, suppliers & manufacturing plants.
• Agility: Lead multiple projects, tasks & priorities simultaneously, flexible to handle rapidly changing project or business need
• Strong Owner Ship & Personal Accountability
• Strong communication skills in both oral & written.
• Team Player
• People Management

Digital Skills

• MS Suite including Microsoft xl, Word, Power point, Outlook
• eBMR, Track & Trace, Track wise
• Digital acumen towards latest technologies …eg  AI tools

Additional Info

• Experience & expertise in different functions (technology transfers, Quality assurance, vendor development, operations, analytical. etc.) is highly desirable.  
• Experience in pharmaceutical greenfield projects desirable but not mandatory
• Expected travel 20% both local  & international
• This role demands higher  flexbility to adjust with  work patterns/timings

Job Qualifications

Graduation / Post graduation in science or pharmacy

Minimum 7 Years hands on experience in the pharmaceutical Industry in Oral solid dosage forms /soft gels /liquids/parentals

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