Manufacturing Project Manager

FACETLLC is a pharmaceutical sciences company specializing in development and manufacturing of products for laboratory, medical, chemical, diagnostic, and government applications.  We help customers bring their products to market from research to launch where operations include formulation development, manufacturing and packaging of liquid and dry products in bulk and dosage forms, complex container/closure systems, and printed packaging materials.

Responsibilities

Manages multiple projects that support the manufacturing of new and existing products.  Responsible for administration of printed packaging materials, batch records, and requirements specification development for products to be assigned to the master schedule.  The Project Manager works closely with operations personnel to ensure training, procedures, processes, inventory, and equipment are established for in-process and finished product.

The Project Manager role serves as a liaison between the customer and management for new product development and integration of process schemes within the plant.  The project manager develops relationships with customers, manages and communicates project status and performance, and ensures alignment with production activities and corporate objectives.  Responsible for successful execution of multiple projects that support manufacturing and packaging of bulk, injectables, oral formulation, fluid delivery, printed packaging materials, and warehousing.

  • Coordinate preproduction administration to meet customer requirements and operational goals
  • Develop and write batch records, SOPs, and training materials that support production activities
  • Ability to operate in a flexible plant that produces multiple products simultaneously for scientific, technical, research-based environments
  • Develop clear and effective written proposals and quotations (RFQ) for current and prospective customers and coordinate with management, R&D, and manufacturing
  • Respond quickly to the customer, expediting the resolution of customer questions, concerns, and problems
  • Develop training programs and train employees on unit operations, safety, and compliance
  • Work with technical personnel to resolve capacity issues and unplanned downtime
  • Perform Root Cause Analysis on deviations, product complaints, and suspect results; develop and implement countermeasures to prevent recurrence and improve reliability
  • Maintain an organized and safe work environment and compliance with training, SOPs, and safe work practices
  • Develop quality systems that ensure conformance to established standards such as batch records, good documentation, site plan, employee checklist, facilities, and equipment, etc.
  • Understanding of cGMP and cGLP
  • Review batch records and procedures and perform lot disposition; coordinate project completion with metrics analysis and performance evaluation
  • Respond quickly to the customer, expediting the resolution of customer questions, concerns, and requests
  • Other duties as assigned

Basic Qualifications:

  • Bachelor’s degree in a Chemistry, Engineering, or other technical related field and 1-3 years work experience preferred
  • Valid Driver’s License

Additional Skills/Preferences:

  • Knowledge/experience in manufacturing, packaging, and/or project management
  • Knowledge of cGLP, cGMP, FDA and USP, regulatory requirements
  • Strong project management skills and highly organized; ability to manage multiple tasks and multiple projects simultaneously
  • Strong work ethic, detail and results orientated
  • Customer focused
  • Proficient in computer skills and desktop office products
  • Basic Adobe products skills preferred (e.g. Illustrator)
  • Familiar with web development and desktop publishing preferred
  • Excellent interpersonal oral and written communication skills
  • May need to be available off shift and respond to production issues
  • Some travel may be required
  • Applicant will work within a production plant. Some chemicals and allergens may be present. Mobility requirements and potential exposure to allergens should be considered when applying for this position
  • Completion of employment application; qualified candidates must be legally authorized to work in the US

FACETLLC is an equal opportunity employer. Qualified applicants are evaluated without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, disability, veteran status, and other protected characteristics