Formulation Scientist I

Avion Pharmaceuticals•Fort Worth, TX

6d•Onsite

About The Position

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

Requirements

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.)
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

Nice To Haves

Advanced degree with a pharmaceutical sciences background, PhD preferred.
2-4 years of experience in a cGMP environment, preferably in pharmaceuticals

Responsibilities

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