Location
Cambridge, MA | United States
Job description
Director* CTSM Strategy
Your responsibilities are:
- Maintaining the overview of CMOs processes to identify and support opportunities /improvements and harmonization for CTSM
- Working with internal and external stakeholders to bring identified opportunities / new ways of working to life.
- Working within CTSM GMP/GCP Compliance & Operations and all associated functions such as CTSM Logistics, Product Supply Organization, etc., to identify improvement opportunities, works out improvement strategies with CTSM Excellence & Strategy and fosters implementation to ensure smooth and reliable execution of operational tasks
- Aligning with CTSM Excellence & Strategy to ensure process landscape related to CTSM GMP/GCP Compliance & Operations is displaying CTSM strategy
- Defining and leading implementation of CTSM GMP/GCP Compliance process initiatives
- Working with CTSM Excellence & Strategy and relevant functions to transfer strategic initiatives into processes e.g., CMC, QA, QP, ClinOps
What you have to offer :
- Relevant completed university education in pharmacy, chemistry, biotechnology, biochemistry or related discipline. Broad and/or in-depth and special task-specific expertise and skills (doctorate, if applicable)Possibly first relevant work experience in an industry setting, preferably in pharmaceutical or biotech industry / other relevant professional experience, such as at a supplier or in procurement
- Relevant professional experience (+5 years) in Clinical Supply, pharmaceutical or biotech industry as well as in Operations & Quality, or related field, such as Packaging & Labelling
- 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 GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
- Deep Knowledge about GMP principles (e.g., SOP's, Process Controls, etc.)
- Deep Understanding of Quality Management Systems (Deviation handling, CAPA and change control processes)
- Experience in compilation and coordination of regulatory documents
- Excellence Project Management Skills
- General understanding of IRT systems and standard office software proficiency (e.g., MS Office)
- Business-professional English language skills
- ·Ability to solve multi-layered and dynamic tasks in flexible and changing framework conditions
- Ability to implement effective change management and to develop and maintain a culture of openness
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 – Cambridge Erie Street, London, 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!
Job tags
Salary
