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Post: Senior Manager - Product Life Cycle Management
Product Lifecycle Management and Specifications is a department of Pharmaceutical Development and Manufacturing Sciences - Small Molecule Value Stream - Analytical Development, within the Janssen R&D organization. The department is responsible for:
* The management of the specifications for the Janssen commercial products (from starting materials to active pharmaceutical ingredients and drug products for small molecules)
* The coordination of the analytical activities in PDMS/SM-AD related to commercial products and central point of contact with the Janssen Supply Chain (JSC)
* Design and improvement of the specification setting process from early development through commercial launch through delisting.
- Science/risk based management of specification setting for Small Molecule APIs, intermediates, starting materials and commercial drug products.
- Issuance of Specification Justification reports through consolidation of development or post-approval information from the JSC sites and from third party suppliers.
- Advise technical teams on API and drug product control strategy, specification and analytical issues.
- Ensure the proper and timely preparation of specification reports and other documents. Critical evaluation and interpretation of current files and data.
- Planning, coordination, tracking, execution and closure of the change control records for new analytical proposals.
- Answer questions, complaints, remarks or suggestions related to specifications from regulatory authorities and/or affiliates. Prepare and support Health Authority inspections and customer audits for assigned portfolio.
- Participate as a technical team member in compliance and/or process improvement initiatives and project teams as related to specifications and analytical maintenance.
- Provide project leadership or participate as team member on more advanced and complex scientific projects across organizations.
- Master in Chemistry, Pharmacy, Biochemistry or equivalent field is required; an advanced scientific degree (PhD) is preferred. A minimum of 12 years of experience in industry or combined industry with relevant post graduate academic research is required.
- Strong technical knowledge and experience with Small Molecule API and DP analytics (methods and specifications) is required. Insight in chemical processes, product quality assurance/control, and product development and manufacturing is an asset.
- Knowledge of global regulatory requirements and guidelines applicable to pharmaceuticals (small molecules) and of the submission process is preferred. Experience with responding to health authority questions related to analytics and specifications is required.
- Demonstrated ability to author, review and approve scientific reports and sections of regulatory filings. Ability to work independently, handle multiple & complex tasks in an organized and productive manner, and respect commitments is required.
- Good communication skills (intercultural & interdisciplinary communication). Cooperate across functions, business units and geographical boundaries.
- Knowledge of English Language, both written and spoken is essential.
Qualification: Master in Chemistry, Pharmacy, Biochemistry
Location: Mumbai- Maharashtra
Requisition ID: 1600113667W
Industry Type: Pharma/Biotech/Clinical Research
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