Associate Director or Director of Production

POSTED: November 13, 2017
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time
START DATE: Immediate Availability

DUTIES/RESPONSIBILITIES:

Essential Functions

  • Manage and direct all manufacturing and packaging activities of the cGMP facility.
  • Ensure activities are performed in compliance with federal regulations and Purdue GMP Center policies and procedures.
  • Provide assistance to other functional areas, as needed, (e.g., Business Development, Development).

Additional Responsibilities

  • Comply with all state and federal laws regarding the manufacture and/or packaging of pharmaceutical products.
  • Direct manufacturing and packaging activities in the production of pharmaceutical products per the cGMPs and client specifications.
  • Maintain production schedule as needed for internal and client driven projects.
  • Assist in planning and organizing production and logistical activities to complete and ship pharmaceutical products to the client/distributor.
  • Provide general oversight to state licensing procedures.
  • Create, execute and review production records compliant of the cGMPs.
  • Assist in client proposal cost quote estimates to the Business Development.
  • Provide guidance and assistance in future plans and capabilities for Purdue GMP Center.
  • Provide knowledge and guidance on pharmaceutical processing techniques and equipment selection, operation and maintenance.
  • Evaluate, procure, operate and maintain process and packaging equipment, as necessary.
  • Provide/apply insights to help on development-related projects.
  • Complete other duties as assigned.

REQUIREMENTS/QUALIFICATIONS:

Knowledge/Skills/Abilities

  • Proficient in Microsoft Word, Excel, PowerPoint and Outlook.
  • Demonstrate a high level of verbal and written communication skills.
  • Ability to effectively interact with staff, management team, clients, visitors, students, senior business leaders, service providers, PRF facilities staff, and University officials.
  • Demonstrate a high level of integrity, judgment, diplomacy, maintain confidentiality and exercise discretion on various matters and customer service.
  • Maintain confidentiality and exercise discretion on various operational matters.
  • Plan and organize staff activities to meet Purdue GMP Center goals and objectives.
  • Prioritize multiple project objectives to optimize the efficiency of the staff.
  • Manage, motivate, and instruct staff to meet Purdue GMP Center’s goals and objectives.
  • Execute at a high level in a multi-disciplined team environment.
  • Apply working knowledge of CFR Part 21.
  • Favorable security (DEA/FBI/criminal) check and negative controlled substance test.
  • Regular and reliable attendance is a requirement of this position.
  • This job description is subject to change by the employer as the needs of the employer and requirements of the job change.

Education/Experience

  • Bachelor's degree in Pharmacy, Science, or Engineering.
  • Indiana pharmacy license preferred.
  • Minimum of seven years of appropriate pharmaceutical production experience with management experience in a cGMP environment.
  • PhD can substitute for work experience in certain instances.

APPLICATION INSTRUCTIONS:

Interested candidates please send your cover letter and resume to humanresources@prf.org.  

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