5 Manager* Clinical Trial Supply Management GCP Operations Jobs in Cambridge, MA
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Manager* Clinical Trial Supply Management GCP Operations
$149k-176k (estimate)
Full Time
3 Months Ago
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BioNTech AG is Hiring a Manager* Clinical Trial Supply Management GCP Operations Near Cambridge, MA
Become a member of the BioNTech Family!
Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.
With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
Manager* Clinical Trial Supply Management GCP Operations
Your main responsibilities are:
- Supports and manages relationships with pharmacies in global clinical trials up to Phase III
- Contact for IMP-related and CTS-related questions for CROs/ Sites / pharmacies
- Contributes to training CROs and sub-contracted IMP services
- Liaises with GCP QA and supports CTSM GCP related activities
- Supports on appropriate CTSM GCP risk communication and ensures CTSM GCP requirements are met
- Manages complaints, deviations, changes, and other quality incidents for GCP topics
- Manages and coaches Specialist CTSM GCP
What you have to offer:
- Relevant professional experience (> 3 years) in Clinical Supply in Pharmaceutical or Biotech industry setting or any equivalent e.g., Pharmacy Services.
- Relevant completed university education in Pharmacy, experience as a Clinical Pharmacist or in an equivalent role.
- Proven track record of supply chain and study drug logistics (set up and management) in global clinical trials up to Phase III
- Deep Knowledge about Pharmacy Manuals / Pharmacy Questionnaires
- Deep Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
- Knowledge about standard office software proficiency (e.g., MS Office)
- Business-professional English language skills
- Self-motivated with strong problem-solving and learning skills
- Ability to create independent analyses and develop new solutions
- Excellent organizational and communicative skills
- Enjoys working in a team
- Ability to coach, mentor, and collaborate with business partners, analysts, and team members
- Openness to explore on new topics for setting up the trend
Benefits for you:
BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30 hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and subsidized parking
- Discounted Home and Auto Insurance
- Pet Insurance
Plus more benefits that will be shared upon hire!
Have we kindled your pioneering spirit?
Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form.
- BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
www.biontech.com
Job Summary
JOB TYPE
Full Time
SALARY
$149k-176k (estimate)
POST DATE
01/27/2024
EXPIRATION DATE
04/12/2024
WEBSITE
biontech.de
HEADQUARTERS
Mainz
SIZE
<25
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