CMO Manager II

The CMO Manager is responsible for managing the Global Contract Manufacturing relationships for commercial drug product-lyophilized parenterals and capsules. The focus for this position is for the management of oncology therapies distributed globally. The CMO Manager will work together with Quality Assurance, Quality Control, Regulatory Affairs, and Technical Operations to ensure product quality and supply demand is consistently met for  Commercial Products. 

ACCOUNTABILITIES: 
• Day to day management of routine production of Drug Product and Finish goods packaging sites. 
• Primary CMO contact for operational and business relationship activities. 
• Leads a core team comprised of QA, QC, Regulatory Affairs, Technical Operations, and Logistics, and Supply Operations Systems personnel to effectively manage CMOs. 
• Responsible for initiation and timely resolution of deviations and change controls associated with routine manufacture of drug product and finished goods. Triages out to Technical Operations for troubleshooting, and management of in depth process investigations, as appropriate. 
• Authors, reviews, and/or approves pertinent SOP’s and manufacturing process instructions. 
• Authors or reviews pertinent CMC sections for regulatory submissions. 
• Participates in CMC teams for key therapeutics distributed globally. 
• Administering purchase orders related to project execution as needed. 
• Identify continuous improvement and process improvement opportunities. 

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
The candidate should preferably have a BS in chemistry, biology, or closely related disciplines and 7+ yrs of experience working in manufacturing, supply chain, or pharmaceutical development. The candidate should have a good working knowledge of manufacturing operations, biologics drug substance manufacturing, drug product manufacturing (oral solid dose and/or parenterals,) pharmaceutical packaging, CMC regulations, cGMP, and sterility assurance techniques. The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment. The candidate should also be self-motivated, able to thrive in a fast paced environment with minimal direction and be able to multitask, to work on a number of deadline driven projects simultaneously with a sense of urgency. Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. 

PHYSICAL DEMANDS: 

• Office work 
• Computer use 
• Airline travel 

TRAVEL REQUIREMENTS: 

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. 
• Position requires up to 25% domestic and international travel.

Company Description

Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.

At The Fountain Group, we know that searching for a new career can be stressful, which is why we take time to understand your skills and personal goals. We understand the importance of job flexibility and professional growth, and offer top-notch positions with leading employers. In fact, the majority of our clients are well known Fortune 100-500 companies. We also offer a variety of benefits to our associates to ensure their overall happiness.

In addition to assisting with your job search, we will help you through every step of the process offering online tutorials and additional resources to enhance your industry knowledge and skills. As your employment agent, we are dedicated to providing career counseling and job advice, knowing precisely what established companies want.

At The Fountain Group, we treat you like family, regardless of your proximity to our office. We are dedicated to providing you with an exciting, challenging and highly rewarding place to work. Become a part of our team today and let us put your talents to work.

If you are interested in hearing more about the position please respond to this email with a copy of your resume in word form with the best contact info Please forward this email to any friends or colleagues

Work location: Cambridge, MA