Director, Manufacturing Operations Position Available In Northampton, Pennsylvania

Director, Manufacturing Operations Particle Sciences Inc, an

Agno Pharma Company Bethlehem, PA Job Details Full-time Estimated:

$124K – $159K a year 14 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Referral program Qualifications Microsoft PowerPoint Microsoft Word Biology Statistics CGMP Microsoft Excel Microsoft Access Microsoft Outlook Management Doctoral degree Bachelor of Science Writing skills Laboratory experience Microsoft Office Master’s degree Doctor of Chemistry Analysis skills Supervising experience Bachelor’s degree Doctor of Philosophy Team management Production planning Organizational skills Manufacturing Senior level Communication skills Mechanical knowledge 10 years Full Job Description Job Summary We are seeking an experienced and dynamic Director of Manufacturing to lead our production operations. The ideal candidate will be responsible for overseeing the entire manufacturing process, ensuring efficiency, quality, and safety standards are met while driving continuous improvement initiatives. This leadership role requires a strategic thinker with a strong background in manufacturing processes and team management. Essential Duties and Responsibilities Direct and manage daily operations in commercial and clinical manufacturing of sterile products and drug implants. Determine staffing requirements and oversee the interview, hiring and training of new employees with the assistance of Human Resources. Ensure all staff receives appropriate training on job duties, corporate policies, applicable regulations and Quality Management Systems. Provide coaching and mentoring and conduct evaluations of all subordinate managers within the department. Ensure all manufacturing areas are appropriate for intended use and maintained in a state of readiness, in compliance with US and EU requirements. Review Master Batch Records, Standard Operating procedures, Qualification/Validation protocols and reports, calibration reports, and other essential cGMP documents, as necessary. Ensure timely, accurate production planning process is maintained, including sourcing and purchasing, coordinate repair and maintenance work within assigned areas. Establish and implement departmental goals, objectives and procedures, conferring with leadership member(s), management team, and staff as necessary. Monitor departmental performance against goals to ensure progress is being made, and corrective/preventive actions are taken if necessary. 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. Interact directly with clients and regulatory agencies, as necessary. Ensure efficient management of quality and cost control. Other duties, as assigned by area management. Knowledge, Skills and Abilities BS/MS/PhD, Engineering, Chemistry, Biology, or Pharmacy. Minimum 10 years of experience in manufacturing sterile pharmaceutical products. 10 years supervisory experience is required. Mechanical aptitude is preferred In-depth knowledge of cGMPs and working in a regulated environment following QbD, cGMP and SOPs is required. Experience writing and developing SOPs, IQ/OQ/PQ protocols, and other regulatory documentation is preferred. Experience participating in or managing audits and inspections from customers and regulatory authorities is required. Proficient with common PC based applications and specifically in the use of MS Office Has high-level user skills with MS Word, Excel, PowerPoint, Access, and Outlook Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials Organization, communication and analytical skills Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors Intermediate mathematical skills, including algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators Ability to define problems, collect data, establish facts, and draw valid conclusions Ability to work varied and extended hours/days, as business dictates To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

Physical Demands:

Regularly lift/carry/move up to 10 pounds, and occasionally lift/carry/move up to 50 pounds May require standing for extended periods of time This position requires the use of respirators. Employees must pass the medical evaluation and fit test to be eligible for respirator use.

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance

Schedule:

8 hour shift Monday to

Friday Experience:

manufacturing sterile pharmaceutical products: 10 years (Required) Ability to

Commute:

Bethlehem, PA 18017 (Required)

Work Location:

In person