This position does have supervisory responsibilities.

1. Directly oversee assigned Production employees
2. Develop weekly/monthly goals and schedules for Supervisors/Leads and manages activities through shift Supervisors and/or Leads
3. Ensure department metrics are updated, accurate, and communicated to staff
4. Participate in all phases of production planning, tech transfer and implementation in collaboration with internal supporting departments
5. Assist with formulating annual budget and its maintenance
6. Oversee progress of Supervisors’ and/or Leads’ daily schedules to ensure safe and timely completion of products and/or projects
7. Liaise with internal groups (QA, QC, Regulatory, etc.) to facilitate issue resolution
8. Conduct, coordinate and document investigations and CAPAs
9. May establish and maintain systems to track department deliverables and trend performance against metrics
10. Ensure unit's compliance with GMP and/or controlled substance accountability, including elements such as documentation (SOPs and validation protocols, etc.)
11. Represent the department during internal and external tours, audits and regulatory audits, including directly interacting with DEA and/or other regulatory agencies
12. Develop written policies, standard operating procedures and methods
13. Review and approve MBRs, SOPs, validation protocols, summary reports
14. Author, approve and oversee completion of deviations, and CAPAs
15. Maintain communication with project management and supporting departments. Highlight issues and makes recommendations to area management and Senior Staff
16. Maintain consistent and direct communication with multiple clients, both on-site and remotely
17. Independently resolves complex issues
18. Complete annual performance appraisal for direct reports
19. Coach and develop junior staff. Work with area manager and senior staff to ensure talent is recognized, rewarded and retained
20. Ensure facility, equipment and personnel operate in a safe manner
21. Perform hazardous waste handling operations in accordance with Curia procedures
22. Perform waste container filling operations and applying identification markers and label, tracks movement of waste from generation point to central accumulation area

· High school education or equivalent

· Minimum 5-8 years’ experience in pharmaceutical manufacturing, including managerial experience in a cGMP environment

· Bachelor’s degree in relevant field

1. Strong supervision skills strongly preferred
2. Thorough knowledge and understanding of GMPs
3. Familiarity with FDA guidelines
4. Excellent communication skills
5. Desire to work collaboratively with clients, vendors, and supporting departments
6. Must be versatile with strong prioritization skills
7. Ability to delegate tasks appropriately to a wide range of skilled technicians and function
8. May be required to pass sterile gowning qualification

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.