Associate Director, Technical Support
Role Overview
The Associate Director for Biosimilars Technical Services provides technical expertise for development, manufacturing, and packaging operations.
The role mitigates quality, regulatory compliance, and supply issues while supporting product launches and lifecycle activities.
The position is based in Andheri, Mumbai, with hybrid working.
Key Skills for This Role
Full Job Posting
About the Role
The Associate Director for Biosimilars Technical Services provides technical expertise for development, manufacturing, and packaging operations.
The role mitigates quality, regulatory compliance, and supply issues while supporting product launches and lifecycle activities.
The position is based in Andheri, Mumbai, with hybrid working.
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company focused on specialty, hospital, and rare disease medicines.
The company commercializes medicines across Europe, Canada, and Australia and operates a Centre of Excellence in Mumbai.
Its portfolio includes innovative medicines, specialty generics, biosimilars, and originator brands.
Responsibilities
- Provide technical expertise for biologic and biosimilar products.
- Resolve manufacturing, packaging, and artwork issues affecting supply, quality, or compliance.
- Lead decisions on manufacturing, product release, and product write-offs with cross-functional stakeholders.
- Analyze processes, recommend improvements, and solve complex business-impacting problems.
- Support acquisitions, critical projects, operational plans, and timely progress reporting.
- Ensure SOPs are available and approved where required.
- Manage budgets for technical activities and review them periodically.
- Train and develop the technical services team and implement performance metrics.
Qualifications
- Bachelor’s degree in chemistry, pharmacy, or another technically relevant graduate-level field.
- Master’s degree in chemistry, pharmacy, or another technically relevant graduate-level field.
- PRINCE2 certification and MS Project experience are specified.
Knowledge, Skills and Experience
- At least 15 years of overall experience, including 10 years in a hands-on biologics or biosimilar technical role.
- Experience may include drug substance or drug product development, formulation and fill-finish, technology transfer, production, or lifecycle management.
- Strong knowledge of sterile biologic or biosimilar products and commercial-scale CMC activities.
- Knowledge of batch planning, manufacturing, packaging, testing, release, distribution, supply, and CDMO operations.
- Working knowledge of upstream and downstream biologics or biosimilars manufacturing.
- Working knowledge of ICH requirements for biologic and biosimilar products.
- Clear communication, collaboration, adaptability, solution orientation, and continuous learning are expected.
Why ADVANZ PHARMA
- The company promotes entrepreneurship, challenge, personal growth, inclusion, and integrity.
- ADVANZ PHARMA offers flexible, agile working options and a competitive salary and benefits package.
- The company promotes from within and recognizes employee contributions through awards.
Application
- Applicants should include a CV and cover letter.
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