Associate Director of Drug Product Manufacturing-Secondary Packaging and supply chain Specialist

Job Description

Associate Director of Drug Product Manufacturing-Secondary Packaging and supply chain 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.

The Biologics Drug Product Primary and Secondary Packaging and Supply chain Expert is responsible for leading and overseeing the packaging processes for biologics drug products and assuring the distribution and supply in co-ordination with Internal and/or external sites. This role involves developing, implementing, and maintaining effective packaging strategies, ensuring compliance with industry regulations, and optimizing packaging operations to meet quality, safety, and timeline objectives at external partners.

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.
• Develop and implement packaging strategies for biologics drug products, considering various factors such as product stability, safety, regulatory requirements, market demands, and supply chain considerations.
• Collaborate with supply chain and procurement teams to identify and qualify appropriate primary and secondary packaging materials and suppliers, considering quality, cost-effectiveness, availability, and supply chain risks.
• Lead packaging design and development activities, working closely with cross-functional teams including R&D, manufacturing, quality, regulatory, and supply chain departments.
• Ensure compliance with cGMP (current Good Manufacturing Practices) guidelines and other relevant regulations throughout the packaging process and collaborate with supply chain teams to establish robust quality and compliance metrics across the packaging supply chain.
• Provide technical expertise and guidance on packaging equipment selection, qualification, and validation, considering supply chain efficiency and compatibility.
• Lead packaging process optimization initiatives to enhance efficiency, minimize waste, reduce costs, and optimize supply chain operations while maintaining product quality and integrity.
• Collaborate with External partners and internal stakeholders to resolve packaging-related supply chain issues, identify alternative sources, and implement continuous improvement initiatives.
• Conduct risk assessments and implement appropriate mitigation strategies to ensure packaging integrity, product stability, and uninterrupted supply chain.
• Provide technical expertise on packaging documentation, including Standard Operating Procedures (SOPs), specifications, and protocols, integrating supply chain requirements and ensuring clear documentation for supply chain traceability.
• Stay updated with industry trends, advancements, and regulatory changes related to biologics drug product packaging and supply chain management.
• The core expertise on pharma serialization process implementation, qualification and lifecycle management.

Education:

• Master’s degree in pharmacy, Chemical Engineering, Supply Chain Management, or a related field. Advanced certifications in packaging, supply chain, or regulatory affairs are preferred.

Required Skills:

• Proven experience in highly regulated certified manufacturing plants with a minimum of 12 yrs experience  in Drug Product vaccines and/or biologics supply chain and packing.
• Solid experience in primary and secondary packaging of biologics drug products within the pharmaceutical industry.
• In-depth knowledge of cGMP regulations and other relevant quality management systems for pharmaceutical packaging and supply chain management.
• Strong understanding of packaging materials, technologies, and equipment used in the biologics drug product industry, and their impact on supply chain operations.
• Demonstrated ability to lead and manage cross-functional teams in packaging-related projects, with a focus on collaboration with supply chain teams.
• Excellent problem-solving and analytical skills, with the ability to identify and resolve packaging-related issues and optimize supply chain processes.
• Effective communication and interpersonal skills to collaborate with internal teams, external suppliers, regulatory agencies, and supply chain partners.
• Detail-oriented mindset with a focus on quality, compliance, and supply chain traceability.
• Ability to prioritize and manage multiple tasks simultaneously in a fast-paced environment, with a strong understanding of supply chain dynamics.
• Proficient in using relevant software applications for packaging design, supply chain management, and documentation.
• Knowledge of integration points between SAP PP and other modules such as Materials Management (MM), Sales and Distribution (SD), and Quality Management (QM).
• Knowledge of serialization implementation methodologies and project management principles.
• Experience in implementing serialization solutions within a pharmaceutical manufacturing environment, including integration with ERP systems.
• Understanding of data integrity and security considerations in serialization processes.
• Proficiency in serialization software platforms and related technologies.
• Strong attention to detail and ability to navigate complex regulatory requirements.
• Knowledge of serialization-related quality control processes, such as aggregation and decommissioning.
• Understanding of the impact of serialization on supply chain operations and logistics.

Preferred Skills:

• Deep knowledge on Biologics packaging requirements, impact on product stability, Cold chain requirements of the biologics/Vaccines, Forecast/Demand and supplies of Biologics, working environment with CMO or External partners and connecting the Internal and external stakeholders with one vision/goal.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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Relocation:

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