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 in the small molecules space. 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 CROs. 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.

Qualifications

PhD in Pharmaceutical Technology/Pharmaceutics with 2 - 5 years of formulation research experience in Pharmaceutical R&D or M Pharm in Pharmaceutical Technology/Pharmaceutics with 7+ years of formulation research experience in Pharmaceutical R&D; first hand experience in developing wide variety of challenging formulations, novel technologies, dosage forms and drug delivery systems would be desirable

Essential skills / competencies

• Capable of conceptualizing product development strategies for fulfilling defined drug delivery goals by using conventional and innovative drug delivery approaches and building development plans to deliver commercially viable products
• Knowledge and research experience of conducting pre-formulation and formulation development activities (composition and manufacturing processes development) for solid and liquid dosage forms including parenteral formulations
• Demonstrated skill of scaling-up the laboratory / pilot scale manufacturing processes to commercial scales and technology transfer experience
• Good understanding of applying concepts of Design of Experimentation (DoEs) and Quality by Design (QBD) in formulation development
• Fundamental knowledge of drug degradation pathways and practical experience of using stabilization techniques for developing stable drug products including the packaging considerations for screening and selecting appropriate primary packaging materials and configurations
• A very good understanding of biopharmaceutics, IVIVC, dissolution methods, developing bio-relevant dissolution methods
• 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

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 emerging and new concepts and technologies
• 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