Manager* CTSM GMP Operations

Hiring By - Biostaffic

 BioPharma

United Kingdom

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Open for hire at one of the following locations – London, Cambridge Erie Street, Mainz Goldgrube. - Job ID: 3089
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Manager* CTSM GMP Operations
Your main responsibilities are:
  • Responsible for GMP process development and continuous improvement in Clinical Trial Supply Management (CTSM ) related to secondary packaging and labeling (P&L) of investigation al medicinal products (IMPs) ( e.g. product specification files, clinical labels, P&L ordering, expiry update, destruction)
  • Responsible for evaluation and implementation of state-of-the-art strategies related to IMP P&L, e.g. just-in-time manufacturing, pooled supplies , process digitalization .
  • Represents CTSM as expert on IMP P&L activities in cross-functional teams
  • Represents CTSM in setup of processes with internal and external P&L CMO ' s including generation & maintenance of knowledge about CMOs' offered processes
  • Responsible for ( coordination of ) label setup for study drugs ensuring regulatory requirements and agreed milestones, quality and costs are met
  • Liaises with GMP QA and other relevant cross functional interfaces and supports on CTSM GMP activities related to IMP P&L
  • Liaises with IMP Manager to define GMP requirements for clinical trial s and setup P&L processes with vendors
  • Supports on appropriate CTSM GMP risk communication and ensures CTSM GMP requirements are met
  • Provides input into Certification and Release Strategy for clinical trial s (e.g., QP declaration, Sponsor release)
  • Reviews, aligns, and provides input to QAAs for internal and external CMO s
  • Coaching of less experienced team members
What you have to offer:
  • University degree in Science, Engineering, Supply Chain Management or related discipline
  • Multiple years of work experience in Clinical Supply in Pharmaceutical or Biotech Industry setting or other relevant professional experience in Packaging and Labeling
  • 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 GMP Principles (SOPs, Documentation, etc.) and Deep Understanding of Quality Management Systems
  • Advanced knowledge in preparing for and participating in audits and inspections
  • Understanding of Planning & Scheduling processes
  • Knowledge about contract settings
  • Knowledge about IRT systems and standard office software proficiency (e.g., MS Office)
  • Effective stakeholder management
Benefits for you
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – London, Cambridge Erie Street, Mainz Goldgrube . Apply now for your preferred job and location through our careers site .
  • 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!

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • United Kingdom

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
BioNTech SE
BioNTech SE

Current Openings: 0

At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. To pioneer the next generation of patient-specific immunotherapies, we have combined ground-breaking research with cutting-edge technologies to develop therapeutics for cancer and beyond. Our broad and synergistic suite of platforms, which include mRNA therapeutics, engineered cell therapies, antibodies and small molecule immunomodulators have been optimized for distinct modes of action, high precision targeting, high potency and efficacy. We are also developing in parallel our own state-of-the-art manufacturing processes to complement our drug development platforms. We were founded in 2008 in Mainz, Germany and have been driven to become the leading global biotechnology company for individualized cancer medicine. We have over 20 product candidates in development, 8 candidates in 9 ongoing clinical trials, treated over 250 patients across 17 tumor types and supported by more than 1100 employees. As we prove the value of our approach in the clinic, we continue to build a network of world-class corporate and scientific collaborators, manufacturing and team required to bring individualized treatments to patients worldwide. To learn more about us, visit https://biontech.de/ Our privacy statement can be found here: https://www.biontech.com/int/en/home/data-privacy-statement.html
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