The incumbent will be responsible to support analytical research and development activities for NCE (new chemical entity), LCM (life cycle management) and NEB (new established brand) projects. The person hired into this position will work in close collaboration with other functional line colleagues (chemistry, formulation, API scale up etc) to best support product and process development in line with project plan. Candidate will be responsible for supporting multiple projects and the interfacing with various customers and partner groups across the organization such as global development team, regulatory, quality, manufacturing and clinical organizations as well as coordinate the analytical activities outsourced to vendors. The candidate will be responsible for authoring various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc.
Post : Scientist
Responsibilities
The incumbent will be responsible to support pharmaceutical research and development activities for NCE (new chemical entity), LCM (life cycle management) and NEB (new established brand) projects. The person hired into this position will work in close collaboration with other functional line colleagues (chemistry, analytical, API scale up etc) to best support product and process development in line with project plan. Candidate will be responsible for supporting multiple projects and interfacing with various customers and partner groups across the organization such as global development team, regulatory, quality, manufacturing and clinical organizations as well as coordinate the product development activities outsourced to vendors. The candidate will be responsible for authoring various documentations such as manufacturing instructions, manufacturing process validation plans, protocols, reports, SOPs, CMC technical sections for regulatory submission etc.
Essential skills / competencies
- Knowledge of pre-formulation and formulation development activities and processes for solid and liquid dosage forms including parenteral formulations
- Basic understanding of developing commercial dosage forms including scale-up and technology transfer experience to pilot/commercial scale
- Basic knowledge on Design of Experimentation and Quality by Design aspects for formulation development
- Fundamental knowledge of drug degradation pathways, stabilization techniques and biopharmaceutical aspects of drug products
- Understanding of packaging considerations for commercial products and primary pack screening and selection activities
- Good understanding of GMP and knowledge of ICH, Pharmacopoeial, Technical and Regulatory requirements in relation to pharmaceutical product development and manufacturing
- Good at interpersonal and communication skills
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Other attributes desirable
- Exhibits a thorough understanding of own scientific/technical area. Stays current with new developments and trends in that area and their application to development projects. Understands and applies in-house technologies (automation, DOE, etc.).
- With general guidance from supervisor, uses knowledge and experience to design, conduct and interpret data from experiments. Plans work independently based on specific objectives. Prioritizes tasks; keeps management/team informed of progress and adjusts work accordingly. Displays knowledge of project goals.
- Demonstrates the ability to identify and recommend solutions for problems that arise in the course of experimentation. Identifies and utilizes the most reliable resources to get at the rootofaproblem.
- Understands safety. Considers safety an integral part of planning for and performance of work function.
- Communicates technical information efficiently and accurately. Practices active listening skills to understand information being communicated by others. Can deliver and articulate presentations in a team environment. Writes clearly and concisely. Maintains laboratory notebook meeting corporate standards.
- Modifies techniques and work processes to improve the way work is done, introducing imaginative approaches and championing new technologies to improve group/team performance.
- Recognizes the importance of relationships within the work group. Builds a sense of partnership with others in the work group to achieve results. Builds and maintains a strong network with people from other departments to enhance collaboration on assignments
Additional Information:
Location: Navi Mumbai
Qualification: M. Pharm/Ph.D
Function: Research and Development
End Date: 30th November, 2017
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