Reports to: Associate Director, Product Development
Position Summary:
Accountabilities’:
Under limited direction and supervision, carries out design and development of formulations and processes by QbD, manufacturing of exhibit batches, preparation of product development reports, support of all necessary documentation for ODR and regulatory submissions
Level of Responsibility: Low
Dimension:
• Must have the ability to identify and analyze unique problems. Ability to efficiently handle pharmaceutical unit operations, such as fluid bed coater, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation and packaging.
• Communicating clearly and concisely, both orally and in writing. Leading the activities of technical personnel; making decisions and satisfying the needs of a research program
• Operating scientific and personal computers. Managing multiple projects, duties and assignments
• Establishing and maintaining cooperative working relationships with others.
Delegation of Responsibility:
In the absence of the Sr. Product Development Scientist, all the above responsibilities shall be discharged by the Associate Director- Product Development or designee.
Job Profile:
• Designs experimental plan; performs pre-formulation, formulation development work and optimize formulation and process by QbD.
• Involves in development of product, raw material specifications including evaluation of physicochemical properties and compatibility of raw materials. Reviews analytical data to support the product development work.
• Plans appropriate analytical testing and stability studies
• Writes protocols and batch records/lab note book to carry out process development and evaluation work, scale up and pivotal batch manufacturing for NDA,ANDA's submission to regulatory agency.
• Prepares pharmaceutical product development report (PDR), Quality overall
• Summary (QOS) and other necessary documents to support regulatory filing
• Surveys the scientific literature and performs patent search to remain current with recent developments in generic pharmaceutical research and regulatory arena and novel drug delivery systems.
• Plans bioequivalence studies on drug product and evaluates the bioequivalence data to recommend changes in formulation, if needed
• Maintains appropriate documentation of primary data records, report sheets and laboratory notebooks as required by Standard Operating Procedures
• Comply with all applicable laws and regulations, and adhered to all policies, procedures and training relevant to the position
• Other responsibilities may be assigned as deemed necessary
• Assessment and Planning of Work.
• Areas where decision is made in consultation with others
• The incumbent must be able to provide scientific and technical directions to staff members, Technicians & Operators to ensure project deadlines and performance standards are met.
• Production schedule of EB batches.
• Regulatory requirements
Problems/ Key Features
• This position has direct impact on the successful performance of the company.
• The incumbent must be able to manage tight time-lines and solve related problems.
• Research and using new technology
Interface:
Internal
• Analytical Sciences
• Technical Services, Validation and Production
• Quality Control, Quality Assurance and Quality Compliance
• Regulatory, Planning Department and Project Management
• External
• Equipment material vendors
Competencies Required:
Technical Competencies
• Advanced knowledge of theories, practices and principles of physical pharmacy, pharmaceutics, pharmacokinetics, bio pharmaceutics and statistical designs
• Product formulations, product stability, packaging, and FDA submission methods and practices
• Product design of controlled release dosage forms, working knowledge of multiparticulate systems, matrix systems, diffusion controlled and osmotically engineered pharmaceutical dosage forms. Experience with other dosage forms is a plus
• Experience with multiple bench top, pilot and manufacturing equipment
• Ability to perform mathematical calculations, operations and basic statistics
• Proficiency in MS Office applications (Word, Excel)
Behavioral Competencies
• Ability to positively interact with personnel of diverse backgrounds.
• Conduct oneself in a professional manner.
• Maintain a positive attitude.
• Strong written and verbal communication skills
• Strong attention to detail