Scientist III, Pharma R & D (Formulation)

---

Job description

Description:

The Scientist III develops and executes formulation strategies related to product development, such as project planning, experimental design and data evaluations. The Scientist III applies technical expertise and has knowledge of various formulation development approaches. Demonstrates leadership and experience in the area of pre-formulation, formulation and process development of immediate and modified solid dosag. The position reports to a Manager/ Principal Scientist as described in the current organization chart of the department.

Essential Functions:

Develops formulation strategy and designs experimental plan, formulation and process development work for oral controlled release and immediate release dosage.
Responsible for selection of raw materials, packaging components and process requirements based on sound scientific principles. Perform formulation screening and optiimization based on physico-chemical and biopharmaceutical properties of drug molecules.
Reviews analytical and clinical data and makes scientific conclusions.
Writes and reviews protocols and batch records for process development and evaluation work, scale up and pivotal batch manufacturing.
Creates and reviews technical documents, reports and presentations for cross functional teams. Writes Modules of ANDA and NDA for submission.
Maintain Design history files for combination products. Develop design and development plan.
Keeps updated on cGMP and current technologies.

Additional Responsibilities:

Provides scientific and technical direction to junior staff members (scientists I, II, technicians & operators) to ensure project deadlines and performance standards are met.
Identifies, analyzes and suggests corrective actions to optimize R&D processes, technologies and regulatory compliance issues.
Equipment: Becomix, Tube filler, Transdermal, liquid manufacturing equipment, high sheer mixer, V-Blenders, Comil, Fitzmill, Hot melt extrusion, tablet press and coating equipment.
Reviews Junior Scientist work.

Qualifications - External

Education:

Master Degree (MS/MA): Pharmaceutical, Chemistry or related technical field - Preferred
Bachelors Degree (BA/BS): Pharmaceutical, Chemistry or related technical field - Required

Experience:

3 years or more experience with a Master Degree in Development of Pharmaceutical Dosage Forms is preferred.
5 years or more experience with a BS in Development of Pharmaceutical Dosage Forms is required.

Skills:

Must have knowledge of Pharmaceutical product development and manufacturing process. - Intermediate
Must be precise and consistent in day to day developmental work, easily trainable and ready to learn. - Intermediate
Must be able to effectively communicate reports, problems or issues, verbally as well as in writing. - Intermediate
Must have good oral and written communication skills. - Intermediate
Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Intermediate
Must follow safe practices as defined by the SOP's and MSDS. - Intermediate
Must be willing to work extended hours as and when required. - Intermediate
Strong interpersonal skills and maintaining cooperative working relationships with others. - Intermediate
Managing multiple projects, duties and assignments. - Intermediate

Specialized Knowledge:

Must possess in depth knowledge and trouble shooting skills.
Must have a good understanding of complex modified release dosage forms.
Must Possess in-depth knowledge of the operation and troubleshooting skills for various lab scale equipments to production scale equipments: including Blenders, granulators, fluid bed dryers, fluid bed coaters, mills, vibrorotatory sifters, encapsulation equipments (Manual to fully automatic), tablet presses and tablet coaters, roller compaction, packaging.
Works independently once assignments and responsibilities are outlined and delegated. Effective in oral and written communication skills at all levels and cross functionally.