Manager/Supervisor of Pharmaceutical GMP Operations

Supernus Pharmaceuticals, Inc. has an immediate opening to hire an experienced management personnel to lead our cGMP Operations department. For more information about Supernus Pharmaceuticals, Inc., please view our website at www.supernus.com.

 

For more information or to apply for this position, please send current resume and salary requirements to Supernus Human Resources department at jobs@supernus.com .

 

This position will have the following RESPONSIBILITIES:
- Direct, organize, and schedule all activities in the cGMP development area
- Organize and maintain SOPs and GMP training for all personnel who may be required to operate equipment in the development area
- Supervise and manage the professional development of all direct reports and make staffing recommendations for the department
- Maintain GMP equipment and facilities as per current federal regulations
- Initiate, direct and execute all development and scale-up strategies for new and existing CTM products
- Plan and execute laboratory research relating to the clinical manufacture of products
- Maintain broad knowledge of state-of-the-art principles and theories
- Serve as in-house and outside consultant for manufacturing practices and equipment, lab safety, and hazardous material use and storage
- May act as spokesperson on corporate research and development and advise top management in the field of expertise
- May participate in the development of patent applications for intellectual property
- Interface with various departments
- Use professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways
- Handle other duties as assigned
- Responsible for all safety issues related to company

 

The REQUIREMENTS for this position include:
- PhD in a scientific discipline or equivalent with 2+ years relevant experience; or MS in a scientific discipline with 4+ years of relevant experience; or BS in a scientific discipline with 6+ years of experience
- Proven ability to supervise and manage staffing issues
- Experience in the procedures required for inventory control, inventory sampling, dispensing, manufacturing and shipping to clinical sites
- Expert knowledge of cGMP and CTM principles and concepts
- Knowledge of the validation process and IQ/OQ for manufacturing and facilities required
- Ability to prioritize and schedule facility, equipment and personnel for multiple manufacturing operations in a short period of time
- Ability to work independently by gathering information and problem solving GMP issues in a manufacturing/packaging environment
- Extensive GMP manufacturing/packaging experience required, preferably with some experience troubleshooting equipment problems
- Knowledge of solid oral dosage related equipment
- Extensive knowledge of batch record, clinical supply documentation and retention
- Demonstrated success in technical proficiency, scientific creativity, collaboration with others, and independent thought

 

Supernus Pharmaceuticals, Inc. is an equal opportunity employer, and celebrates workplace diversity.