Bioequivalence Jobs (NOW HIRING)

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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

Minimum Educational Qualifications required for the job

MS or PhD in Pharmacy or Pharmaceutical Technology or Chemistry.

5+ years of experience for MS and 3+ years' experience for PhD in developing various dosage forms.