Associate Director of Manufacturing Operations

Avion Pharmaceuticals•Marietta, GA

18h

About The Position

Manages 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.

Requirements

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
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

Nice To Haves

Demonstrated experience, including troubleshooting, with, pilot scale and commercial-scale processing equipment and unit operations for oral solid dosage forms, is optional but desired.
Six Sigma and/or Process Excellence and/or Lean certification

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.
Providing guidance to production staff for the correct execution of production batch records and packaging batch records.
Writing and/or review of production deviation reports.
Technical problem solving, operational improvements and efficiency improvements to reduce operating costs.
Scheduling manufacturing activities as well as coordinating equipment maintenance and validation activities.
Supporting the Pharmaceutical Science team, as needed, for process development activities.
Recruiting, interviewing, hiring and training production staff and developing direct reports to establish career progression opportunities within the department and origination.
Serving as a process expert, technical resource and coach for the production team.
Adhering to capital and expense budgets as well as managing to standards and manpower requirements to meet production requirements.
Developing and maintaining operator training programs to standard operating procedures.
Creating and maintaining an environment of innovative continuous improvement, focusing on quality, cost reduction, process development and capacity.
Reviewing/writing operational SOP’s, recommending changes as appropriate.
Providing 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.
Performing other duties as assigned or requested.