summary / objective
Support Sovereign’s analytical development activities to achieve successful design, filing, transfer and launch of 505(b)2, ANDA and OTC products.
· Perform release and stability testing for raw materials and drug products
· Execute method transfers and method equivalency studies
· Conduct method validation experiments as per written protocols
· Performs characterization of physical and chemical characteristics of drug product and raw materials.
· Peer review laboratory notebooks, data, protocols and reports
· Understands applicable cGMP, DEA regulations and Quality Procedures
· Performs other tasks as assigned.
This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers, phones, and copiers. The employee is occasionally exposed to toxic and/ or caustic chemicals such as Sodium Hydroxide, Hydrochloric Acid, Acetonitrile, Methanol, and other chemical solutions necessary in analytical chemistry.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must regularly lift and/ or move up to 50 pounds. Specific vision abilities required by this position include close vision, color vision and the ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand, walk, sit and talk or hear. The employee is occasionally required to climb or balance, stoop, kneel, crouch, crawl and smell.
position type/expected hours of work This is a full-time position. Days and hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required.
required education and experience
· Advanced degree with Chemistry background, Masters preferred
· 2-5 years experience in pharmaceutical laboratory
· Operation of HPLC and efficient with Empower 3 Software
· Compendial/Non-compendial testing of raw materials
· Adhere to all laboratory requirements in accordance with SOPs and regulatory practices such as GMPs, GDPs, GLPs, and OSHA regulations.
· Understanding of Analytical Chemistry including but not limited to the following techniques and how to utilize them, as needed, for projects, both simple and complicated, as assigned:
o Sample Preparation Techniques
o Titration/electrode chemistry
· Effective communication skills, written and verbal
· Demonstrate project management skills
· Organizational and interpersonal skills
· Ability to innovate new ideas
preferred education and experience
· Advanced degree with Chemistry background, Masters preferred
· 2-5 years experience in pharmaceutical laboratory
· Ability to handle multiple projects
work authorization/security clearance (if applicable)
Authorized to work in the U.S.