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Post: Manager - Analytical Development
Job Description
Overview
The Pharmaceutical Development & Manufacturing Sciences Organization (PDMS) of Janssen R&D, constituting of around 1200 people across the globe, aims to develop and bring products to the patients in a timely manner without delays. With a vision of ‘One passionate team transforming molecules to medicines for patients worldwide’ the PDMS Organization covers Active Pharmaceutical Ingredient (API) – Small Molecules, API – Large Molecules, Drug Product Development, Analytical Development, Portfolio Management, Clinical Supply Chain and Strategic Operations. Clinical Release & Stability (CRS) is a department of PDMS within the Janssen R&D organization. The department is responsible for clinical release and stability testing of Drug Substance (DS) and Drug Product (DP) for small molecules covering Phase 1 through Phase 3, DS and DP manufacturing process and product characterization support and the stability process for small and large molecules in R&D.
This position is in one for the external partner site (based in MUMBAI) of AD group at Higi, which is responsible for IND/CTA, NDA stability along with clinical release samples
• Department : PDMS - Clinical Release & Stability
• Location: Partners Site, Mumbai
• Division/ Sector: Janssen
• Reports To: Director –AD-CRS
Responsibilities:
The roles and responsibilities of this position include:
• Technical project delivery support from the outsourcing partners site to CRS Organization by interfacing with key stakeholders for all critical small molecule analytical projects to enable 100 % on time delivery.
• Ensure participation and focused progress of Analytical development groups/projects and other involved Technical integrator functions and facilities are transcribed onto partners site.
• Support strategy at partners site such as to meet Janssen organisation requirements as per compliance is met.
• Coordinate the execution of cross-site, cross-functional analytical deliverables, for method development, process scale-up, tech transfer, through late development.
• Responsible for the output and quality for technical reports and regulatory documentation through the writing of technical analytical content for regulatory submissions.
• Responsible for the resolution of Analytical project issues and lead QC-analytical activities at CRO/CMOs including release and stability testing, analytical methods transfer, qualification, validation and implementation.
• Routinely interface with PDMS Analytical Development, Business Development units, Formulations, Regulatory Affairs, and Quality Assurance to meet demand suppy gap control needs across multiple programs.
• Extensive interactions with the SPOC, functional Project leads such that lab is virtually available.
• Ensure alignment with stakeholders, early to late development and manufacturing for small molecules, such that the same is executed at partner sites
• Responsible for providing input to Project leads such as working as an extended arm for Analytical
Technical Project lead at partners site.
• Collaborating with the QC and Microbiology department of the Partners site so as to give virtual visibility to CRS Director on the analytical schedule, equipment use, investigations and analytical method trouble shooting.
• Shall be stationed at partners site
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Key Interaction Areas: Extensive interactions with multidisciplinary and multi-site groups and technical integrators which may include external vendors and/or strategic suppliers
Quality & Compliance Responsibilities: Performs activities following the GMP/safety requirements related to the assigned activity
Candidate Profile
Education:
• MS Degree in Analytical Chemistry, Pharmacy, or equivalent life sciences degree. Ph.D. is preferred
• At least 12 plus years of experience in reputed pharmaceutical company
Functional competencies (Skills, Knowledge and Attributes):
• General knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process.
• Knowledge of analytical or biochemistry in a R&D environment.
Behavioral Competencies (Leadership Imperatives):
• Technical and Project management skills, excellent writing and communication skills.
• Ability to foster team productivity and cohesiveness in a complex matrix environment.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics
Additional Information:
Location: Mumbai- Maharashtra
Requisition ID: 1600081351W
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
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