Associate Director* CMC Manufacturing Technologies
Open for hire at one of the following locations – Shanghai. - Job ID: 7366
Join our team of pioneers!
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.
Associate Director* CMC Manufacturing Technologies
The Associate Director CMC Manufacturing Technologies is a key member of a global CMC team and will be responsible for leading tech transfer processes from one CDMO to another across different continents during the clinical stage. This involves collaborating with internal and external teams to ensure a seamless and efficient technology transfer. The role also includes serving as the operative CDMO manager, overseeing day-to-day operations at the CDMO, and ensuring compliance with company policies and business requirements. Additionally, the Associate Director CMC Manufacturing Technologies will lead CMC due diligence activities, ensuring a comprehensive evaluation of all aspects of the development program and appropriate identification and reporting of risks.
Your main responsibilities are:
- Lead the tech transfer of clinical-stage processes from one CDMO to another, including project planning, risk assessment, and oversight of transfer activities
- Develop and maintain project timelines, budgets, and resource plans for tech transfer projects
- Collaborate with internal and external teams to ensure successful technology transfer
- Serve as the project-specific primary point of contact for the CDMO, managing the onboarding and day-to-day operations and ensuring that all activities are in compliance with company policies and contractual requirements (scope of work)
- Establish and cultivate strong relationships with CDMO partners, fostering effective communication and collaboration. Represent CMC internally in the Supplier Relationship Team.
- Lead CMC due diligence teams during the evaluation of China-based development programs, working closely with cross-functional teams to evaluate all aspects of the program and identify and report risks appropriately.
- Provide regular updates to senior management on project status, risks, issues and CDMO performance
What you have to offer:
- Bachelor's degree in a scientific or engineering field, advanced degree preferred
- Minimum of 7 years of experience in pharmaceutical or biotech industry, with at least 5 years of experience in technology transfer and/or CDMO management
- Strong project management skills, with experience leading cross-functional teams and managing budgets and timelines
- Knowledge of GMP regulations and requirements for biopharmaceutical manufacturing
- Expertise in the development and manufacturing of protein-based therapeutics and ADCs
- Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
- Ability to work independently and prioritize tasks in a fast-paced, dynamic environment
- Strong intra-cultural expertise and fluency in English, both written and verbally
This is a challenging and rewarding role for an experienced professional with a strong background in technology transfer and CDMO management. The successful candidate will have the opportunity to impact critical projects and contribute to the growth and success of a leading biotech company.
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 – Shanghai. Apply now for your preferred job and location through our careers site.
*BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. 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!