Formulation Scientist I

summary/objective Support Sovereign's Formulation development activities to achieve successful design, filing, transfer, and launch of 505(b)2, ANDA, ANADA, and OTC products.

Essential functions

Monitoring their project activities to ensure timely completion. Reviewing their protocols, manufacturing processes, and reports for accuracy Designing protocols, developing plans, and pre-formulations and formulation activities. Developing process, manufacturing instructions, and technology packages. Writing project updates.

Work with process/manufacturing personnel for successful and effective transfer of technology. Author technical documents such as protocols and reports Performs characterization of the physical characteristics of drug products and raw materials. Peer review laboratory notebooks, data, protocols, and reports Identifies non-routine technical problems & recommends solutions Provide leadership in technical transfers between companies and internally Understand applicable cGMP, DEA regulations, and Quality Procedures Recommends new technology & science to meet department goals Required education and experience Advanced degree with pharmaceutical sciences background.

2-4 years of experience in solid and liquid dosage forms development Adhere to all laboratory requirements in accordance with SOPs and regulatory practices such as GMPs, GDPs, GLPs, and OSHA regulations. Knowledge of pharmaceutical research and development Statistical experimental design techniques Bench/Pilot scale operations (granulation, compression, coating, etc.)

Preferred education and experience Advanced degree with a pharmaceutical sciences background, PhD preferred. 2-4 years of experience in a cGMP environment, preferably in pharmaceuticals Required skills/competencies Effective communication skills, written and verbal Organizational and interpersonal skills Ability to innovate new ideas Demonstrate project management skills Professional Self-Starter Organized and detail-oriented Reliable and Dependable Ability to handle multiple projects Abstract problem-solving skills Confidentiality Highly efficient and accurate 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 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, 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, and other chemical solutions necessary in formulation development.

The employee may also be required to wear personal protective equipment to provide adequate protection from raw materials.