Assistant Manager - R&D Job

Job description

Assistant Manager
- R&D-1500058639WDescriptionJohnson & Johnson
- Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas.
Job Description:Job Title (India Specific): Assistant Manager – R&DDepartment: PDMS – SMMD
- ADJob Location: MumbaiDivision: PharmaceuticalReporting To: Senior ManagerPosition Summary: Knowledge of dissolution method development and industrial experience in the area of In Vitro dissolution method development using various dissolution apparatus. Experienced in physiology based dissolution testing and desirable knowledge of pharmacokinetics to predict in vivo performance of drug product. Good knowledge of current regulatory guidance on topic of dissolution is desirable. Ability to communicate and collaborate both within and across the research groups. Good knowledge of English, both spoken and written.
Job Responsibilities:
- Dissolution method development and support formulation development of different types of Formulations Like Tables and Capsules using dissolution apparatus USP
- I , II , III and IV
- Designs and executes scientific experiments. Provides scientific leadership. Actively and personally involved in lab work. Originates and develops new project ideas. Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information.
- Is responsible for the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, reviews data and draws conclusions.
- Ensures the proper and timely preparation of technical reports, manuscripts and other documents
- Analyzing and drawing interpretation out of the dissolution data sets.
- Trouble shooting the problems associated with instruments or methods.
- Writing Method Development & Validation reports.
- Design of experimental set up and interpretation of data.
- Peer data review in a compliant way.
- Performing activities following the GMP/ safety requirements related to the assigned activity.
Key Interaction Areas: Drug Product Development, Pharma Science group, Biopharm Team, Clinical Team, Spec management teamQuality & Compliance Responsibilities: Is responsible for the proper recording of information. Ensures that records and raw data are properly retained.
QualificationsEducation & Certifications: M.Sc. or M.Pharm, Ph.
D. preferredExperience: About 10 Years of industrial experience in formulation or Analytical development, dissolution development experience preferred.
Functional competencies (Skills, Knowledge and Attributes):
- Discriminatory Dissolution method development for Oral solid dosage form.
- Physiology Based Dissolution testing.
- Basic knowledge of Pharmacokinetics and its correlation to in vitro dissolution.
- Biorelevant dissolution testing of Oral Solid Dosage form.
- Clinical Relevance and correlation of dissolution method.
- Instrument operation-Dissolution Apparatus I,II, III and IV, HPLC and UPLC.
- QbD based method development using DOE software and interpretation.
- Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations.
Behavioral Competencies (/Leadership Imperatives):
- Good Communication and presentation skills.
- Should a team player.
- Decision making capabilities.
- Good Collaborative skills.
- Planning and execution.
Primary Location:Asia Pacific-India-Maharashtra-Greater MumbaiOrganization: Johnson & Johnson Private Limited (8080)Job Function: R&D