Gaithersburg, US | full time | Job ID: 11410 About the Role: As a Senior Scientist I in Process Development at BioNTech, you will play a key role in advancing our antibody pipeline, which is central to our therapeutic st…
Skills: Downstream Processing, Process Development, Monoclonal Antibodies, Scale-up, Technology Transfer
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Smithers - Materials and Components
Associate Project Manager or Project Manager
Gaithersburg, Maryland, United States · Hybrid
$88k–$130k/yr
Senior
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$114k–$182k/yr
Full-time
postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, AD&D Insurance, Critical Illness Insurance
Posted 23d ago
Apply by Dec 1
~40 hrs/week
Responsibilities
Lead the development, optimization, and characterization of downstream purification processes for monoclonal antibodies. Contribute to CMC documentation and regulatory submissions while managing scale-up and technology transfer activities.
Requirements
Requires a PhD with 6+ years of experience or an MS with 8+ years of industry experience in biologics process development. Must have expertise in downstream unit operations and a strong understanding of PPQ/BLA readiness.
Full job description
Gaithersburg, US | full time | Job ID: 11410
About the Role:
As a Senior Scientist I in Process Development at BioNTech, you will play a key role in advancing our antibody pipeline, which is central to our therapeutic strategy. This position offers the opportunity to actively contribute technical leadership to downstream processing development while supporting CMC strategy for regulatory submissions. You will be part of a dynamic, lab-based team that thrives on collaboration and innovation to drive impactful results.
In this role, you will leverage your expertise in downstream processing to develop scalable purification processes, optimize manufacturing workflows, and ensure compliance with global regulatory standards. Your ability to distill complex data into actionable insights will be critical in shaping BioNTech’s success in delivering novel therapies to patients worldwide.
Your Contribution:
Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges for process characterization Lead development, optimization, and characterization of downstream processes, including scale-up, virus/impurity clearance, and resin/membrane lifetime Conduct downstream process unit operations such as depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation Collaborate with cross-functional teams to design experiments, analyze results, support technology transfers, and meet project timelines Contribute to CMC documentation by drafting process descriptions, characterization reports, QbD risk assessments, and other technical reports Drive the creation of best practices and workflows for process development in a fast-paced environment
A Good Match:
PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related discipline with 6 plus years of relevant experience (including post-doctoral training), or MS with 8 plus years of industry experience 6 years’ experience in global pharma PD or MS&T for monoclonal antibodies or related biologics Expertise in downstream process development including scale-up and technology transfer Proven ability to design and execute process characterization studies using scale-down models that inform PPQ strategy Strong understanding of biologics CMC processes including PPQ/BLA readiness; experience with antibody or ADC development preferred Demonstrated technical leadership within cross-functional teams and programs Willingness to travel domestically and internationally as required by program needs
Your benefits and remuneration:
Expected Pay Range: $113,600/year to $181,600/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.
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
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.
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2008
Headquarters
Mainz, Rhineland-Palatinate
LinkedIn followers
300,826
Total funding
$2.0B
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
🔗 Privacy Statement: https://www.biontech.com/int/en/home/data-privacy-statement.html
🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
BiotechnologyIndividualized cancer medicinePatient-specific immunotherapymRNA therapeuticsCell therapyAntibody therapeuticsSmall molecule immunomodulatorsTailored therapeuticsImmunotherapyOncology
How many Healthcare jobs are open in Gaithersburg, MD right now?
There are currently 349 open healthcare positions in Gaithersburg, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Gaithersburg, MD?
Companies currently hiring include AstraZeneca, Asbury Communities, Inc., Adventist HealthCare, Sheppard Pratt, BAYADA Home Health Care, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Gaithersburg, MD?
Yes — 96 of the 349 open healthcare positions offer remote or hybrid work (6 remote, 90 hybrid).
How do I apply for Healthcare jobs in Gaithersburg, MD?
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