Overview

Manage routine manufacturing tasks under the guidelines of established procedures and cGMP regulations under guidance of senior management and provide leadership to other employees.

Candidate Requirements

  • Bachelor’s degree in life sciences or equivalent training and/or experience is necessary.
  • Two to five (2-5) years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required.
  • Proven self-starter.

Available for off-shift and/or on-call work, as needed.

Responsibilities

  • Manage routine manufacturing activities; including day to day scheduling and raw materials/consumables management.
  • Provide leadership when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling duties as needed.
  • Accurately document data and complete batch records as needed.
  • Successfully complete facility’s gowning and manufacturing qualification program.
  • Perform and train other employees in various manufacturing tasks, including, but not limited to: fill/finish, lyophilization, gowning, sanitization, and component and equipment preparation activities.
  • Operate production equipment.
  • Perform and assist in the development of formulation activities.
  • Perform duties in ISO 4.8 and ISO 7 cleanrooms.
  • Execute and author well-defined procedures and assist other technical personnel on issues and problems.
  • Initiate revisions to cGMP/procedure guidelines.
  • Assist in the scheduling and performance of routine maintenance of production equipment.
  • Oversee operations of the production areas, including the warehouse and utility areas.
  • Participate in client communications, including problem solving, schedule development, and project status updates.
  • Perform routine performance assessments with direct reports.
  • Define and uphold disciplinary actions for poor performance of direct reports, as necessary.
  • Foster a positive team environment that promotes productivity and employee satisfaction
  • Support Agency, customer and vendor audits as needed.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Perform all other tasks, projects, and duties as assigned.

Skills

  • Prior GMP sterile manufacturing experience preferred.
  • Professional and positive approach.
  • Proven leadership skills.
  • Self-motivated.
  • Ability to follow procedures and regulatory guidance documents.
  • Strong in building relationships and able to communicate at all levels.
  • Team player, and able to work on own initiative.
  • Proficiency in both written and verbal communication and presentations.
  • Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
  • Results oriented and efficient.
  • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
  • Ability to work closely with a diverse customer base (internally and externally).
  • Ability to work well in a cross-functional team environment.
  • Must have proficient computer skills in Microsoft Word, Excel and Outlook.

If you would like to be considered, please submit your resume on our careers page.