Contract Manufacturing Business Manager at PETNET Solutions, Inc. in Knoxville, Tennessee
Posted in Other 2 days ago.
Job Description:
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
Beware of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site .
"Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."
As an equal opportunity employer, we welcome applications from individuals with disabilities.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities.
To all recruitment agencies:
Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.
#LI-BM1
PETNET
Equal Employment Opportunity Statement
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.
Reasonable Accommodations
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accommodation for disability form If you're unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here .
