Formulation Scientist I

Alora Pharmaceuticals, LLC.; Fort Worth (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Sovereign is seeking a formulation development professional to support design, filing, transfer and launch of pharmaceutical products. The role involves coordinating project timelines, reviewing protocols and processes, and creating robust technical documentation.

Ideal candidates hold an advanced degree in pharmaceutical sciences with 2–4 years in dosage form development, and experience in cGMP environments. Strong communication, organization, and problem-solving skills are essential.

Qualifications

• Advanced degree in pharmaceutical sciences.
• 2–4 years of experience in solid and liquid dosage forms development.
• Knowledge of GMP, GDP, GLPs, and OSHA regulations.

Responsibilities

• Monitor project activities to ensure timely completion.
• Review protocols, manufacturing processes and reports for accuracy.
• Design protocols, development plans, and pre-formulations.
• Develop processes, manufacturing instructions and tech packages.
• Write project updates and technical documents.
• Lead technology transfer activities between sites and partners.
• Understand cGMP, DEA regulations and Quality Procedures.

Skills

Effective communication

Organizational skills

Project management

Self-Starter

Detail oriented

Multitasking

Problem solving

Confidentiality

Reliability

Accuracy

Education

Advanced degree in pharmaceutical sciences

PhD preferred

Job description

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.