Scientist

2 months ago

Somerset, United States Buzzclan IT Services Pvt. Ltd Full time

**Job Title - Formulation Scientist**
**Location - Somerset, NJDuration: Long Term contractRole Summary**
Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment.

**Essential Duties and Responsibilities**
- Review Literature and gather patents and published articles on the selected projects.
- Analyze and interpret results in written and oral format in consultation with Product Development Management.
- Determine the best possible strategy for formulating assigned projects and meet regulatory criteria.
- Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms.
- Perform formulation experiments to develop ANDA or NDA submission batches.
- Responsible for CMC documentation, project documentation and for preparing necessary technical reports.
- Perform all the processing steps such as weighing, blending, milling, compression etc.
- Directs the work and schedules of technicians and provides technical assistance to associates and other formulation scientists.
- Maintain accurate lab notebooks and complete all related development reports, in compliance with departmental needs and SOPs.
- Technical responsibility for interpreting, organizing, executing and coordinating assignments and assigned development projects.
- Maintains liaison with individuals and units within or outside of the organization as directed by Product Development Management.
- Plans, organizes and supervises the assigned work staff of associates and technicians.
- Responsible for project management of assigned product development projects.
- Responsible for the production of clinical supplies
- Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with the manufacturing department as needed.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices.

**Education & Experience**
- Master’s degree (or higher) in a pharmaceutical science field preferred.
- Minimum 4 years of experience in pharmaceutical drug product development, preferably in generic pharmaceuticals.
- Technical expertise necessary to design pharmaceutical products and manufacturing processes.
- Proven ability to supervise technical and operational personnel.

**Job Type**: Contract

Pay: $35.00 - $40.00 per hour

Expected hours: 40 per week

Schedule:

- 8 hour shift

**Experience**:

- Formulation: 5 years (required)
- NDA submission: 4 years (required)
- ANDA submission: 4 years (required)
- Drug Development: 5 years (required)
- GMP: 4 years (required)

Work Location: In person

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