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Post: Executive - R&D
Job Description
Position Summary:
- 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 CRS group at Higi, The CRS Group is responsible for IND/CTA, NDA stability along with clinical release from Pilot Plant.
Job Responsibilities:
- Technical review of project data generated at CRS organization.
- Technical review of data generated at partners’ site for CRS Organization by interfacing with key stakeholders.
- Responsible to meet 100% on time delivery of assigned project activities.
- Support partners to harmonise the data review process as per the Janssen requirements.
- Responsible for review of qualification and calibration data of Instruments and equipment’s.
- Understanding of the current GMP requirements and different regulatory requirements related to Lab operations.
- Interact with Project leads and scientific integrators as per the need to resolve analytical issues.
- Good understanding of Quality systems and ability to investigate non compliances.
- Fair amount of experience in handling events, deviations, Change controls and CAPAs.
- Knowledge on instrument qualification and calibration process.
- Understanding of 21 CFR part 11 requirements.
- Hands on experience in handling all general analytical instruments in the labs.
- Technically strong and good understanding of analytical techniques such as chromatography, dissolution, Moisture determination, particle size determination, spectroscopy etc.
- This role requires fair amount of domestic travel (about 30%) to Partner sites.
Qualifications
Education & Certifications: MS Degree in Analytical Chemistry, Pharmacy, or equivalent life sciences degree.
Experience: At least 8 years of experience in reputed pharmaceutical company.
Functional competencies:
- General knowledge of the pharmaceutical drug development process.
- Knowledge of ICH guidelines and pharmacopeia requirements.
- Understanding of method development, Method validation and Method transfer requirements.
- Good understanding of statistical tools in applied analytical chemistry
Behavioral Competencies:
- Ability to work in teams
- Good communication and writing skills
- Good Interpersonal skills with the ability to adapt to the organisational dynamics.
- Flexibility and commitment to target delivery
Additional Information:
Experience: Min 8 years
Qualification: B.Pharm, M.Pharm
Location: Mumbai- Maharashtra
Functional Area: R&D
Industry Type: Pharma/Biotech/Clinical Research
End Date: 10th December, 2015
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