DescriptionManages all manufacturing and related activities required to support the production of clinical supplies, commercial batches, development, engineering and registration batches of oral solid dosage products. Responsible for leading the production of solid dose products to fulfill project schedules, within determined quality and safety standards. Supervises, develops and provides direction to assigned staff. This position works closely with Pharmaceutical Sciences, Engineering, Validation and Quality Assurance.
Essential Responsibilities:- Managing a staff of production personnel to ensure safety and quality compliance are prioritized for manufacturing goals of all manufacturing both commercial and product development.
- Responsible for providing guidance to production staff for the correct execution of production batch records and packaging batch records.
- Responsible for the writing and/or review of production deviation reports.
- Responsible for technical problem solving, operational improvements and efficiency improvements to reduce operating costs.
- Responsible for scheduling manufacturing activities as well as coordinating equipment maintenance and validation activities.
- Supports the Pharmaceutical Science team, as needed, for process development activities.
- Demonstrated experience, including troubleshooting, with, pilot scale and commercial-scale processing equipment and unit operations for oral solid dosage forms, is optional but desired.
- Recruiting, interviewing, hiring and training production staff and developing direct reports to establish career progression opportunities within the department and origination
- Serve as a process expert, technical resource and coach for the production team.
- Adhere to capital and expense budgets as well as manage to standards and manpower requirements to meet production requirements.
- Responsible for developing and maintaining operator training programs to standard operating procedures.
- Create and maintain an environment of innovative continuous improvement, focusing on quality, cost reduction, process development and capacity.
- Reviews/writes operational SOP's, recommending changes as appropriate.
- Provides input into operational strategic plans and activities.
- Responsible for safety, and compliance with state and federal laws to include OSHA and DEA activities for the manufacturing department.
- Performs other duties as assigned or requested.
Core Competencies:- Good communication skills both written and verbal
- Ability to read, analyze and interpret technical procedures or government regulations.
- Ability to demonstrated good problem solving skills and conflict resolution.
- Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management.
- Knowledge of cGMP's, regulatory guidelines and validation principles
- Working knowledge in MS Office products
- Dynamic self-starter with ability to handle multiple projects in a high paced work environment.
- Must have a bias for action and ability to make decisions
Minimum Qualifications:- Bachelor's degree in a science or technical area (chemistry, biology, quality, chemical or pharmaceutical engineering)
- 5 years' experience in manufacturing of solid dose products, with at least 3 years' experience managing direct reports
- Knowledge of pharmaceutical production and application of cGMP regulations in manufacturing environment
Preferred Experience- Six Sigma and/or Process Excellence and/or Lean certification
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
