summary/objective
Support Sovereign’s analytical development activities to achieve successful design, filing, transfer, and launch of 505(b)2, ANDA, and OTC products.
essential functions
- Perform release and stability testing for raw materials and drug products
- Develop and validate analytical methods on various quantitative instruments
- Execute method transfers and method equivalency studies
- Conduct method validation experiments as per written protocols
- Author technical documents such as protocols and reports
- Performs characterization of physical and chemical characteristics of drug product and raw materials.
- Peer review laboratory notebooks, data, protocols, and reports
- Identifies non-routine technical problems and recommends solutions
- Understands applicable cGMP, DEA regulations, and Quality Procedures
- Recommends new technology & science to meet dept goals
- Train other analysts on new instrumentation and techniques
- Utilize MasterControl QMS Software to train on, review, and approve official documents such as test methods, protocols, and reports.
- Performs other tasks as assigned.
required skills/ abilities
- 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:
- HPLC
- Dissolution
- UV/Vis
- FTIR
- Mass Spectrometry
- Sample Preparation Techniques
- GC
- Titration/electrode chemistry
- Others as appropriate
- Effective communication skills, written and verbal
- Demonstrate project management skills
- Organizational and interpersonal skills
- Ability to innovate new ideas
- Ability to handle multiple projects.
- Self-starter, organized, dependable, and goal-oriented.
required education and experience
- Advanced degree with Chemistry background, Master’s preferred
- 8-12 years of experience in a pharmaceutical laboratory
- Operation of HPLC and proficient with Empower 3 Software
- Compendial/Non-compendial testing of raw materials
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.
physical demands
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.
work environment
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.