Gaithersburg, US | full time | Job ID: 11211
About the Role:
As Director of Analytical Development, you will play a pivotal role in advancing our antibody and ADC programs from early clinical development through BLA readiness. Your expertise will drive the technical strategy for product-specific analytical development, ensuring our methods and strategies align with BioNTech's mission to revolutionize cancer treatment and immunotherapy.
Working in non-GMP laboratories, you'll collaborate closely with cross-functional teams-including Process Development, Global Technical Development leads, MS&T, AS&T, QC, Regulatory, and Quality-to deliver robust analytical solutions that directly impact our success. You'll thrive in an innovative environment where your contributions shape the future of biologics manufacturing.
Your Contribution:
Partner with global team leads to develop and implement robust method development processes and analytical control strategies
Identify analytical risks and data gaps; design and execute mitigation studies such as comparability, forced degradation, structure-function analysis, stability testing, and investigations
Establish internal best practices and analytical playbooks in a fast-paced environment
Support the definition of CQAs and associated control strategies through experimental studies across various phases
Contribute to CMC documentation (IND/IMPD, BLA/MAA) by providing technical input on analytics, product characterization, and investigations
Lead a team of technical experts in hands-on laboratory work including method development, troubleshooting, and lifecycle management
A Good Match:
PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 10+ years of relevant experience; or MS with 12+ years of industry experience
Extensive experience in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage clinical manufacturing/BLA readiness preferred
Hands-on expertise in biologics method development, qualification/validation, transfer processes; knowledge of ADC-specific analytics desirable
Strong understanding of biologics CMC guidelines (e.g., ICH Q6B), QbD principles, PPQ/BLA readiness strategies, specification setting & justification
Proven leadership experience within dynamic cross-departmental environments; excellent communication skills to influence across matrixed teams
Preferred requirements: Global regulatory experience (e.g., submissions or partnerships in US/EU/China
If the position is filled in the US, the Expected Pay Range is $168,100/year to $268,700/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.