Senior Formulation Scientist: Tech Transfer Lead

Sovereign Pharmaceuticals

Fort Worth (TX)

On-site

USD 120,000 - 170,000

Full time

12 days ago

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Job summary

Sovpharm in Fort Worth, TX seeks an experienced Formulation Development Scientist to support design, filing, transfer and launch of complex dosage forms (505(b)2, ANDA, ANADA, OTC). You will lead tech transfers, ensure cGMP compliance, and collaborate with manufacturing and QA to drive projects to completion.

The role requires a PhD with 6–12 years in solid/liquid dosage forms and strong problem-solving and project management skills.

Qualifications

  • Advanced degree with pharmaceutical sciences background, PhD required.
  • 1
  • 6–12 years of experience in solid and liquid dosage forms development.
  • 6–12 years of experience in a cGMP environment in pharmaceuticals.
  • Adhere to all laboratory requirements in accordance with SOPs and regulatory practices such as GMPs, GDPs, GLPs, and OSHA regulations.
  • Effective communication skills, written and verbal
  • Knowledge of pharmaceuticals research and development
  • Statistical experimental design techniques
  • Bench/Pilot scale operations (granulation, compression, coating, etc.)
  • 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

Responsibilities

  • Monitor project activities to insure timely completion.
  • Reviewing their protocols, manufacturing process 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 physical characteristics of drug product and raw materials.
  • Peer review laboratory notebooks, data, protocols and reports
  • Identifies non-routine technical problems & recommend solutions
  • Provide leadership in technical transfers between companies and internally
  • Understands applicable cGMP, DEA regulations and Quality Procedures
  • Recommends new technology & science to meet department goals

Skills

Effective communication
Statistical design
Project management
Organizational skills
Detail oriented
Problem solving
Adaptability
Team collaboration
Documentation writing
SOP compliance

Education

PhD in pharmaceutical sciences
6–12 years in dosage form development
cGMP pharmaceutical experience

Job description

Sovpharm in Fort Worth, TX seeks an experienced Formulation Development Scientist to support design, filing, transfer and launch of complex dosage forms (505(b)2, ANDA, ANADA, OTC). You will lead tech transfers, ensure cGMP compliance, and collaborate with manufacturing and QA to drive projects to completion.

The role requires a PhD with 6–12 years in solid/liquid dosage forms and strong problem-solving and project management skills.

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