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
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