Associate Director or Director, Manufacturing Solutions

POSTED: November 30, 2020
BUSINESS: Parsolex
POSITION TYPE: Full-time 
START DATE: Immediate Availability

Essential Functions :

• Direct and manage all manufacturing and packaging activities of a current Good Manufacturing Practices (cGMP) facility providing contract analytical, development, and manufacturing solutions to pharmaceutical companies
• Ensure activities are performed in compliance with federal regulations and Purdue GMP Center (PGC) policies and procedures
• Collaborate with management on strategic planning and execution to achieve corporate objectives and ambition
• Develop and manage the budget and  have responsibility for the profit and loss for department
• Be responsible for achieving business development objectives / targets, including dollar sales and project profitability
• Author proposals, including scope and budget, for external (client) and internal projects and manage resources against these activities
• Participate in strategic initiatives, including lead generation and vetting of new business opportunities to achieve top-line growth targets
• Collaborate with and advise other functional areas, as needed, (e.g., Client Services, Development, Analytical, Quality, Engineering/Facilities)
• Manage and mentor operations staff to achieve operational excellence

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 non-sterile, pharmaceutical products per the cGMPs and client specifications
• Assist in planning and organizing production and logistical activities to complete and ship pharmaceutical products to the client/distributor
• Procure materials and equipment as needed
• Provide general oversight to state licensing procedures
• Create, review and execute cGMP documentation, including batch records, that meet the standards of PGC Quality
• Develop capital equipment growth plans, performing diligence and making recommendations
• 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

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 PGC staff and 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
• Prioritize multiple project objectives to optimize the efficiency of the staff
• Manage, motivate, and instruct staff to meet PGC’s goals and objectives
• Execute at a high level in a multi-disciplined team environment.
• Apply working knowledge of CFR Part 21

Education/Experience:

• Bachelor's degree in pharmacy, science, or engineering
• Minimum of 10 years of appropriate pharmaceutical production experience with management experience in a cGMP environment
• Experience in technical services preferred
• PhD can substitute for work experience in certain instances

Environmental/Hazardous Conditions:

• Exposure to dust, odors, gases, noxious fumes, toxic chemicals (biological and/or chemical agents)
• Exposure to moving objects and vibration
• Proximity to mechanical parts and noise

Requirements:

• 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

Application Instructions:

Interested candidates please send your cover letter and resume to careers@gmpcenter.com