Contract Manufacturing Business Manager

Knoxville, Tennessee


Employer: PETNET Solutions, Inc.
Industry: Legal & Compliance
Salary: Competitive
Job type: Full-Time

Title:

PETNET Solutions Contract Manufacturing Business Manager

Scope:

The PETNET Solutions Contract Manufacturing Business Manager will be responsible for coordinating and driving day to day operations related to contract manufacturing activities at the participating PETNET pharmacies. The role requires working closely and collaboratively with PETNET team members to prioritize and drive project implementations in support of new products, new contract manufacturers, process maintenance and improvement for External Manufactured and Contract Manufactured products at PETNET Solutions, a multi-national, wholly-owned subsidiary of Siemens Molecular Imaging. PETNET is the worldwide leader in the manufacturing and distribution of radiopharmaceuticals for positron emission tomography. This position is located in Knoxville, TN.

Summary of Responsibilities:

The position is responsible establishing and maintaining alignment between the 3 rd party drug sponsor and key PETNET functional teams in order to drive alignment of key goals and metrics between centralized and decentralized operational activities . Responsibility also includes the ability to influence across the PETNET organization (Operations, Engineering Services, QA/QR, and others) and build effective relationships both internal and external and interface with senior management and 3 rd party drug sponsors.

Specific Responsibilities:

  • Serve as a liaison between the drug sponsor and PETNET Manufacturing, PETNET Manufacturing Engineering and other support groups, PETNET Quality and Regulatory, Legal and PETNET Executive Management
  • Support contract development and negotiations for manufacture of 3 rd party clinical and commercial drugs in alignment with PETNET's strategic plan
  • Analyze and use statistical data in support of decisions
  • Work cross-functionally to ensure continuity of supply for contract manufactured products according to contractual terms and obligations
  • Coordinate and drive resolution to the working issues and day to day relationships with 3 rd party drug sponsors
  • Establish and manage business, operations, and quality relationships and communications between PETNET and the drug sponsor as a point of contact for the contract manufacturing relationship
  • Coordinate among cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve operational and quality objectives, plans, and performance goals
  • Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues as agreed with 3 rd party drug sponsors

Organizational responsibilities

• Key leadership position that must work cross functionally within organization to drive overall business results

• Interface with external and internal customers and suppliers to drive continual process and service improvements

• Primary interface between drug sponsor and key PETNET functional teams in order to drive alignment of key goals and metrics between centralized and decentralized operational activities

General

• B.S. or B.A. degree in Life Sciences, Physical Sciences, Engineering or related scientific discipline is required.

• Minimum 4 years experience in the development , production and/or support of PET biomarkers used in Phase 3 clinical trials or commercial operations

• Experience managing contract manufacturing or other 3rd party client relationships

• Strong interpersonal, organizational and managerial skills

• Excellent attention to detail in the execution of job responsibilities

• Ability to accomplish multiple tasks in fast-paced environment

• Travel as required to perform job function

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://jobs.siemens-healthineers.com/careers

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PETNET

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Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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Created: 2024-06-25
Reference: 420392
Country: United States
State: Tennessee
City: Knoxville
ZIP: 37918


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