Sr. AD Scientist

Sovpharm; Fort Worth (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Sovpharm is seeking an experienced analytical chemist to support development activities for 505(b)2, ANDA, and OTC products in a pharmaceutical lab environment.

The role involves release and stability testing, method development/validation, and method transfers using HPLC, dissolution, UV/Vis, FTIR, MS, GC, and other techniques. Strong communication, project management, and training skills are required. Extended hours may be needed.

Qualifications

• 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

Responsibilities

• Support analytical development activities for design, filing, transfer, and launch of products (505(b)2, ANDA, OTC)
• Perform release and stability testing for raw materials and drug products
• Develop and validate analytical methods on quantitative instruments
• Execute method transfers and method equivalency studies
• Conduct method validation experiments per protocols
• Author protocols and reports; train analysts on instrumentation
• Peer review notebooks, data, protocols, and reports
• Identify non-routine problems and propose solutions
• Ensure compliance with cGMP, DEA regulations, and quality procedures
• Recommends new technology to meet dept goals
• Utilize MasterControl QMS to train, review, and approve documents
• Work with toxic and caustic chemicals in lab environment

Skills

Analytical chemistry

HPLC

Dissolution

UV/Vis

FTIR

Mass spectrometry

GC

Titration/electrode chemistry

Empower 3 Software

MasterControl QMS

Education

Advanced degree in Chemistry

Master’s preferred

Tools

Empower 3 Software

MasterControl QMS

Job description

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.