Formulation Development Manager

Avion Pharmaceuticals, LLC; Fort Worth (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

Avion Pharmaceuticals, LLC in Fort Worth, TX seeks a senior leader to oversee formulation development for 505(b)2, ANDA, ANADA and OTC products. The role drives pre-formulation, process development, and tech transfers with a focus on cGMP compliance.

The ideal candidate holds a PhD in pharmaceutical sciences and brings 10+ years in solid and liquid dosage forms development within a cGMP environment, along with exceptional leadership and communication skills.

Qualifications

• PhD in pharmaceutical sciences or related field.
• 10+ years in solid and liquid dosage forms development.
• 10+ years in a cGMP environment in pharmaceuticals.
• Familiar with SOPs and regulatory practices (GMPs, GDPs, GLPs, OSHA).
• Strong communication and project-management skills.

Responsibilities

• Coordinate the Formulation Development group activities.
• Manage raw materials evaluations for new incoming materials.
• Review protocols, manufacturing processes and reports for accuracy.
• Design protocols, develop plans, and pre-formulations and formulation activities.
• Lead technology transfer between sites and clients; ensure successful transfers.
• Ensure adherence to cGMP, DEA regulations and quality procedures.

Skills

Formulation development leadership

Project management

cGMP/GDP/GLP knowledge

Communication

Problem-solving

Education

PhD in Pharmaceutical Sciences

Tools

Bench/Pilot scale operations

Regulatory compliance knowledge

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

• Coordinates the activities of the Formulation Development group which includes the following
• Manages raw materials commodity evaluations for new incoming materials
• Conduct performance evaluation of direct reports
• Train other scientists on new equipment and techniques
• Monitoring the team’s project activities to ensure timely completion.
• Review protocols, manufacturing processes and reports for accuracy
• Designing protocols, developing plans, and pre-formulations and formulation activities.
• Developing process, manufacturing instructions and technology packages.
• 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 & recommends 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
• Interacts with clients via email, teleconferences, and on-site visits
• Performs other tasks as assigned.

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.

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

JOB DESCRIPTION

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.

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.

REQUIRED EDUCATION AND EXPERIENCE

• Advanced degree with pharmaceutical sciences background, PhD required.
• 10+ years of experience in solid and liquid dosage forms development
• 10+ 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
• Upholds Confidentiality
• Highly efficient and accurate

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

PREFERRED EDUCATION AND EXPERIENCE

• Advanced degree with pharmaceutical sciences background, PhD required.
• 10+ years’ experience in solid and liquid dosage forms development
• 10+ years’ experience in a cGMP environment preferably in pharmaceuticals