09 Aug
|
BIOCON BIOLOGICS
|
Bengaluru
09 Aug
BIOCON BIOLOGICS
Bengaluru
Job DescriptionRole description
NLead tracking & reportingof end-to-end execution of generics manufacturing and quality programs for commercial manufacturing. Drive cross-functional coordination to ensure timely delivery, regulatory compliance, product quality, supply continuity, and successful commercialization of generic pharmaceutical products.
NKey Responsibilities
n1. Program Management
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- Develop and maintain integrated trackers, milestones, timelines, budgets, and governance dashboards.
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- Track progress and ensure on-time delivery of key manufacturing, quality, regulatory, and supply chain deliverables.
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- Lead operations reviewsand provide management updates on risks, opportunities, and mitigation plans.
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- Drive accountability across cross-functional teams to achieve project objectives.
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n2. Quality & Compliance
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- Partner with Quality teams to ensure compliance with GMP, regulatory requirements, and company quality standards.
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- Oversee project-relateddeviations, CAPAs, change controls, investigations, and quality risk management activities.
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n3. Cross-functional Leadership
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- Collaborate with Manufacturing, QA, QC, Regulatory Affairs, MSAT, Supply Chain, Procurement, R&D;, and External Manufacturing teams.
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- Facilitate decision-making and issue resolution among stakeholders.
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- Drive alignment across global and regional teams to meet business priorities.
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n4. Risk & Stakeholder Management
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- Identify project risks and develop mitigation strategies.
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- Escalate critical issues proactively and drive timely resolutions.
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- Manage communication with senior leadership and present project progress, challenges, and recommendations.
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nQualifications & Experience
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- Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, Chemical Engineering, or related discipline.
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- 8–15 years of experience in pharmaceutical manufacturing, quality, technical operations, program management, or related functions.
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- Proven experience managing complex pharmaceutical projects, preferably in generics manufacturing and commercialization.
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- Solid understanding ofGMP, regulatory requirements, technology transfer, validation, and quality systems.
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nKey Competencies
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- Program & Portfolio Management
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- Manufacturing Operations
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- Quality Systems & Compliance
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- Risk Management
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- Regulatory Knowledge
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- Leadership & Influencing Skills
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- Stakeholder Management
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- Problem Solving & Decision Making
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- Executive Communication
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📌 Project Manager (Generics Manufacturing & Quality) (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru