Manufacturing Operations Director

Há 2 dias

Belém, Pará, Brasil Particle Sciences Inc, an Agno Pharma Company Tempo inteiro
Job Summary

We are seeking a highly experienced and skilled Manufacturing Operations Manager to lead our production operations. The ideal candidate will oversee daily operations, drive strategic planning, and ensure operational excellence in our commercial and clinical manufacturing facilities.

Key Responsibilities
  1. Direct and manage daily operations, including supervision of production personnel engaged in the manufacture of drug products.
  2. Determine staffing requirements and oversee the interview, hiring, and training of new employees with the assistance of Human Resources.
  3. Ensure all staff receives appropriate training on job duties, corporate policies, applicable regulations, and Quality Management Systems.
  4. Provide coaching and mentoring and conduct evaluations of all subordinate managers within the department.
  5. Ensure all manufacturing areas are appropriate for intended use and maintained in a state of readiness, in compliance with US and EU requirements.
  6. Review Master Batch Records, Standard Operating Procedures, Qualification/Validation protocols and reports, calibration reports, and other essential cGMP documents, as necessary.
  7. Ensure timely, accurate production planning process is maintained, including sourcing and purchasing, and coordinate repair and maintenance work within assigned areas.
  8. Establish and implement departmental goals, objectives, and procedures, conferring with leadership member(s), management team, and staff as necessary.
  9. Monitor departmental performance against goals to ensure progress is being made, and corrective/preventive actions are taken if necessary.
  10. Maintain awareness of inventory for consumable and packaging goods used in manufacturing. Develop and manage vendor relationships as needed. Provide oversight of ordering, organization, and stocking in manufacturing areas, as appropriate.
  11. Interact directly with clients and regulatory agencies, as necessary.
  12. Ensure efficient management of quality and cost control.
  13. Other duties, as assigned by area management.
Requirements
  1. BS/PharmD/PhD in Pharmacy, Engineering, or related discipline.
  2. 10 years of related experience in the pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP).
  3. Supervisory experience is required.
  4. Mechanical aptitude is preferred.
  5. In-depth knowledge of cGMPs and working in a regulated environment following QbD, cGMP, and SOPs is required.
  6. Demonstrated experience with pharmaceutical/biopharmaceutical manufacturing is required.
  7. Experience writing and developing SOPs, IQ/OQ/PQ protocols, and other regulatory documentation is preferred.
  8. Experience participating in or managing audits and inspections from customers and regulatory authorities is required.
  9. Proficient with common PC-based applications and specifically in the use of MS Office.
  10. Has high-level user skills with MS Word, Excel, PowerPoint, Access, and Outlook.
  11. Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals, and materials.
  12. Organization, communication, and analytical skills.
  13. Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors.
  14. Intermediate mathematical skills, including algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators.
  15. Ability to define problems, collect data, establish facts, and draw valid conclusions.
  16. Ability to work varied and extended hours/days, as business dictates.
Physical Demands
  1. Regularly lift/carry/move up to 10 pounds, and occasionally lift/carry/move up to 50 pounds.
  2. May require standing for extended periods of time.
  3. This position requires the use of respirators.
  4. Employees must pass the medical evaluation and fit test to be eligible for respirator use.
  5. Proper fit testing requires the employees to be clean shaven.
Benefits
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Retirement plan
  • Vision insurance
Work Schedule
  • 8 hour shift
Relocation
  • Bethlehem, PA Required)
Work Location
  • In person

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