Associate Director or Director, Manufacturing Solutions

POSTED: August 27, 2018
BUSINESS: PGC
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