Gaithersburg, US | full time | Job ID: 9427
About the role:
As Analytical Transfer Lead, you will play a pivotal role in advancing BioNTech's mission to develop cutting-edge therapies. As part of the Analytical Sciences and Technology (AS&T) team, you will be responsible for ensuring smooth analytical transfers within our manufacturing and testing network. Acting as the single point of contact (SPoC) for Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and internal sites, you will lead critical processes that facilitate innovation and operational excellence.
Your work will directly contribute to the onboarding of new partners into BioNTech's network and support routine operations, helping us maintain our commitment to delivering high-quality therapies to patients worldwide.
Your contribution:
Define, maintain, and facilitate communication between internal teams, external partners, and CMOs to ensure compliance and harmonization of analytical testing strategies
Lead analytical technology transfer projects across BioNTech’s internal and external manufacturing network
Conduct analytical investigations and problem-solving activities during technology transfers and routine production
Oversee the creation, revision, and approval of work instructions, transfer/validation documentation, and other supporting materials
Support the evaluation and implementation of state-of-the-art technologies for maintaining advanced analytical methods in collaboration with stakeholders
Provide troubleshooting support and drive continuous improvement initiatives in laboratory settings
A good match:
Bachelor's degree in biology, chemistry, pharmacy, biotechnology, or a related field. 6 plus years of experience in a regulated environment within the biotechnology or pharmaceutical industry, ideally under GMP standards.
Demonstrated expertise in leading analytical transfers including method implementation, optimization, troubleshooting, and validation
Strong knowledge of therapeutic protein analytics (e.g., antibodies or ADCs), particularly in areas such as HPLC, bioassays, or ELISAs
Exceptional organizational skills with an ability to manage multiple priorities effectively in a dynamic environment
Detail-oriented mindset with strong problem-solving abilities
Preferred qualifications:
Experience managing QC aspects at external partners like CMOs, familiarity with US, EU, EMA, and FDA regulatory standards. Advanced degree.
If the position is filled in the US, the Expected Pay Range is $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.
Your Benefits
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
…and more! More details to be shared.
Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.
Apply now - We look forward to your application!
Apply for our Gaithersburg, US location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.
BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.
BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.
Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html
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