Gaithersburg, US | full time | Job ID: 11547 About the Role: As the Associate Director AS&T Lifecycle Management, you will be making a meaningful contribution to the ongoing product development and regulatory submission …
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Director, Oncology Commercial Data Science & AI Products
Gaithersburg, Maryland, United States · Hybrid
$186k–$279k/yr
Senior+
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$146k–$234k/yr
Full-time
postgraduate degree
Benefits, Annual Bonus, Equity
Posted 13d ago
~40 hrs/week
Responsibilities
Provide technical analytical expertise for antibody laboratory activities and manage method lifecycle activities for late-stage and commercial projects. Act as a Subject Matter Expert for regulatory filings and submissions to health authorities.
Requirements
Requires an advanced degree in a scientific field with over 10 years of experience in a regulated pharmaceutical environment. Must have comprehensive expertise in analytical methods for ADCs and a strong background in CMC activities for biological products.
Full job description
Gaithersburg, US | full time | Job ID: 11547
About the Role:
As the Associate Director AS&T Lifecycle Management, you will be making a meaningful contribution to the ongoing product development and regulatory submission (BLA/MAA) of our Protein-based therapeutic pipeline as part of our Analytical Sciences & Technology (AS&T) department. In this role, you will be the main point of contact for specific methods within your area of expertise. You will ensure that the analytical methods comply with GMP standards and provide accurate, precise, and reliable results.
Your Contribution:
Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory, and for late-stage and commercial projects across a global network • Responsible for the design and performance of method validations and transfers as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations); potential hands-on work in the laboratory required • Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners • Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products • Act as analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions
A Good Match:
An advanced university degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related field with 10+ years in a regulated environment in the pharmaceutical industry • Comprehensive expertise in analytical methods specific for ADCs: Drug-to-antibody ratio, Free drug, Residual impurities, Unconjugated antibody, Conjugate variants, Conjugated small molecule impurities, Charge variants; additionally beneficial: HPLC, GC, Mass spectrometry, NMR, and IR techniques for the analysis of Linker-payload intermediate • Hands-on experience with assay development, design and performance of method validations, as well as data analysis and statistical evaluation • Strong background in CMC activities for late-stage development and commercial biological products • In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices • Proven experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities • Experience in working in intercultural, cross-functional, and global teams • Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies • Highly motivated and willingness to work in a fast-paced and fast-evolving environment
Preferred Qualificaitons:
• Experience managing method validation and transfer activities across external partners. • Demonstrated ability to lead and support QC quality events and root cause investigations.
Your benefits and remuneration:
Expected Pay Range: $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.
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
300,447
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 much do Management & Leadership jobs in Gaithersburg, MD pay?
Based on 226 listings with disclosed salaries, most management & leadership jobs in Gaithersburg, MD pay between $54k–$241k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Gaithersburg, MD right now?
There are currently 271 open management & leadership positions in Gaithersburg, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Gaithersburg, MD?
Companies currently hiring include AstraZeneca, Adventist HealthCare, Asbury Communities, Inc., BAYADA Home Health Care, Five Below, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Gaithersburg, MD?
Yes — 83 of the 271 open management & leadership positions offer remote or hybrid work (4 remote, 79 hybrid).
How do I apply for Management & Leadership jobs in Gaithersburg, MD?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.