BioNTech

Lead state-level legislative and regulatory strategies to influence policy and foster relationships with government officials and industry stakeholders. | 10+ years of experience in state government affairs or public policy, proven success in influencing legislation, and strong relationship-building skills. | New Jersey, US   |   full time   |   Job ID: 11012     About the Role:   As Director, State Government Affairs, you will lead BioNTech's state-level engagement strategy, ensuring patient access to our innovative pipeline of medicines. This field-based role focuses on identifying and addressing key legislative and regulatory issues across multiple states that impact our business and patients. Your work will directly shape state policies to create favorable environments for our products, contributing to BioNTech’s mission of improving global health. You will collaborate across functions to develop proactive strategies that mitigate risks, leverage opportunities, and support product launches, access, reimbursement, and regulatory pathways. By building relationships with government officials and industry associations, you will play a pivotal role in advancing BioNTech’s priorities and bringing life-changing medicines to patients.   Your Contribution:   Develop and lead BioNTech's state-level legislative and regulatory strategies in collaboration with the US Commercial team.Shape public policy to ensure a favorable environment for product launches and patient access.Monitor state legislative developments; identify risks/opportunities and align strategies with internal stakeholders.Build strong relationships with government officials, regulatory agencies, and industry associations.Educate internal teams on emerging trends while integrating their feedback into strategic planning.Manage external consultants and lobbyists to ensure alignment with BioNTech’s priorities.   A Good Match:   Bachelor's degree with demonstrated expertise in state government affairs or public policy with 10 plus years of experience. Proven success influencing state legislation/regulation and fostering relationships with decision-makers.Strong skills in communication, coalition-building, and strategic planning.Ability to interpret complex policies, assess commercial implications, and collaborate cross-functionally.Comfortable managing regional responsibilities across multiple states; travel readiness required.   Preferred Qualifications: Experience with Medicaid policy, formulary processes, or state-level drug pricing frameworks and background within biopharmaceutical or biotech industry   This is your opportunity to join a dynamic team dedicated to advancing medicine through innovation. Apply now to make an impact at BioNTech!   US based candidates expected Pay Range: $168,100 - $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.        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:   Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Auto & Pet Insurance   …and more! More details to be shared.    Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.   Apply now - We look forward to your application!   Apply for our New Jersey, 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.

Lead downstream process development and characterization for monoclonal antibody manufacturing, supporting regulatory submissions. | PhD in a related field with extensive experience in biologics process development, scale-up, and CMC support, including BLA readiness. | Gaithersburg, US   |   full time   |   Job ID: 10993     About the Role:   As a Senior Scientist II in Process Development, you will play a pivotal role in advancing BioNTech’s antibody pipeline—a cornerstone of our therapeutic strategy. Your expertise will contribute directly to shaping downstream processing development and supporting CMC strategies for regulatory submissions. You will be part of a collaborative, lab-based team that thrives on innovation and precision. Together, we aim to redefine process development standards while contributing to BioNTech’s mission of pioneering immunotherapy solutions. This is your opportunity to influence key departmental goals and make a tangible impact.   Your Contribution:   Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing Lead studies and FMEA assessments to establish critical process parameters and proven acceptable ranges Optimize and characterize downstream processes including virus/impurity clearance, resin/membrane lifetime, and scale-up Execute all unit operations in downstream processing such as chromatography, viral filtration, and formulation Collaborate with cross-functional teams to design experiments, analyze results, support tech transfers, and ensure BLA readiness Contribute to CMC documentation by preparing process descriptions, protocols/reports, and QbD risk assessments   Requirements:   PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related field with 8 plus years’ relevant experience; or MS with 12 plus years of industry experience Extensive background in global pharma PD or MS&T for monoclonal antibodies or biologics.   Proven expertise in downstream process development including scale-up and technology transfer Demonstrated ability to conduct process characterization using DoE studies in scale-down models Solid understanding of biologics CMC with experience supporting PPQ/BLA readiness Strong leadership skills within cross-department technical teams Open-minded approach to ambiguity with a drive for innovation   Preferred Requirements:   Late-stage/BLA experience    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:   Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Auto & Pet Insurance   …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.

Develop and optimize LC-MS methods for biologics, lead qualification and validation efforts, and support regulatory submissions. | PhD in a related field with 8+ years industry experience, expertise in LC-MS, biologics characterization, and global pharma experience. | Gaithersburg, US   |   full time   |   Job ID: 10735     About the Role:   As a Senior Scientist II, Analytical Development, you will play a pivotal role in advancing BioNTech's mission to revolutionize healthcare through innovative antibody and ADC products. You will be part of a dynamic, lab-based team, driving technical excellence in LC-MS method development and characterization while contributing to regulatory strategies and submissions. Your expertise will directly support our goal of delivering high-quality therapies to patients worldwide. In this role, you will thrive in a fast-paced environment where ambiguity is an opportunity. Your ability to distill complex data into actionable insights will be instrumental in shaping analytical strategies and ensuring compliance with regulatory standards. Join us and make a meaningful impact on cutting-edge biopharmaceutical development.   Your Contribution:   Develop and execute phase-appropriate LC-MS strategies across early and late development stages, including BLA-enabling activitiesIdentify analytical risks and gaps; design mitigation plans and study strategies such as comparability, stability, characterization, and investigationsMentor scientists in LC-MS fundamentals, fostering scientific rigor and continuous improvement within the teamDefine and refine internal workflows and best practices for analytical development in high-impact environmentsLead optimization and qualification of LC-MS assays across platforms (e.g., intact mass, peptide mapping, released glycan analysis)Implement Multi-Attribute Methods (MAM) for antibody characterization, QC support, comparability studies, and change control   Requirements:   PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with relevant post-doctoral and 8 plus years industry experience; alternatively MS with substantial industry experienceHands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g China and/or global partners) is advantageousStrong background in biologics CMC principles including ICH Q6b standards, PPQ/BLA readiness, analytical control strategies, and specification settingExperience developing characterization methods for antibodies (e.g., glycans analysis) using diverse ionization modes preferredProven track record as a technical leader within cross-functional teams in dynamic environmentsOpen-minded approach to ambiguity; ability to create structured solutions where none exist   Prefered requirements: 7 plus years in global pharma AD and/or AS&T for monoclonal antibodies or related biologics; late-stage / BLA experience.  Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g China and/or global partners) is advantageous   US based candidates expected Pay Range: $130,800 - $209,400/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.      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:   Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Auto & Pet Insurance   …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.