Top 128 Medical laboratory scientist Jobs in Gaithersburg, Md

Associate Director, AS&T Lifecycle Management (Chemical Method Expert)
BioNTech AG —Gaithersburg, MD
- $146,300 - $234,100 a year
- Full-time
- Background check
- Senior level
- Commercial
- Health savings account
- AD&D insurance
Associate Director, AS&T Lifecycle Management (Biological Method Expert)
BioNTech AG —Gaithersburg, MD
- $146,300 - $234,100 a year
- Full-time
- Background check
- Senior level
- Commercial
- Health savings account
- AD&D insurance
Medical Laboratory Scientist I
Quest Diagnostics —Gaithersburg, MD
- $26.48 - $43.70 an hour
- Full-time
- OSHA
- Bachelor of Science
- HIPAA
- Employee stock purchase plan
- Disability insurance
Quick Apply
13d
Scientist I/II - Bioconjugation
MacroGenics,Inc./MGNX —Rockville, MD
- $86,100 - $146,300 a year
- Bachelor of Science
- Analysis skills
- Bachelor's degree
- Paid parental leave
- Employee stock purchase plan
Quick Apply
Public Health Laboratory Scientist I
Fairfax County Government —Fairfax, VA
- $58,043.44 - $101,575.97 a year
- Weekends as needed
- English
- Office
- Driver's License
- Paid holidays
- Disability insurance
5d
Medical Lab Scientist I - Part - time - DCMC
Luminis Health —Lanham, MD
- $39.50 - $44.52 an hour
- Part-time
- Bachelor's degree
- Mentoring
- 1 year
- AD&D insurance
- Paid holidays
13d
Clinical Laboratory Scientist
GAP SOLUTIONS INC —Bethesda, MD
- $75,000 - $135,000 a year
- Email
- Bachelor of Science
- Writing skills
- Bachelor's degree
Quick Apply
Medical Laboratory Scientist II - Core Lab Night Shift
MedStar Health —Washington, DC
- $35.68 - $64.71 an hour
- Full-time
- Customer service
- Data analysis skills
- Mid-level
Medical Laboratory Scientist 1
Inova Health System —Fairfax, VA
- Part-time
- Mid-level
- Bachelor's degree
- 1 year
- Free parking
- Retirement plan
1d
Biologist I
Battelle —Washington, DC
- $66,000 - $93,000 a year
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- Bachelor's degree
- Wellness program
- Health insurance
Biological Scientist
Global Solutions Network Inc —Bethesda, MD
- $75,000 - $89,000 a year
- Full-time
- Microsoft Outlook
- Mid-level
- Master's degree
- Travel reimbursement
- Profit sharing
Quick Apply
Assistant Scientist, Biologist
MRIGlobal —Gaithersburg, MD
- $55,000 - $66,000 a year
- 8 hour shift
- Bachelor of Science
- Analysis skills
- Quality control
- Paid parental leave
- Paid holidays
Quick Apply
3d
Medical Technologist PRN - Microbiology
Holy Cross Health —Silver Spring, MD
- $29.86 - $43.34 an hour
- Part-time
- Hospital
- 5 years
- Computer literacy
- Opportunities for advancement
- Flexible schedule
13d
Scientist
Smithers PDS LLC —Gaithersburg, MD
- $70,000 - $85,000 a year
- Extended hours
- Computer literacy
- Bachelor of Science
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
14d
Lab Supervisor 1 - Analytical Development
Merck KGaA —Rockville, MD
- $81,900 - $122,800 a year
- Mid-level
- Master's degree
- Bachelor's degree
- Paid holidays
- Disability insurance
Scientist 2 - Stability
Merck KGaA —Rockville, MD
- $71,700 - $132,000 a year
- Oracle
- Bachelor of Science
- Mid-level
- Paid holidays
- Disability insurance
Associate Scientist
Meso Scale Diagnostics, LLC. —Gaithersburg, MD
- $78,100 - $116,200 a year
- Public speaking
- Mid-level
- Master's degree
- Paid parental leave
- AD&D insurance
Quick Apply
9d
Laboratory Technician / Scientist / Manager
Psomagen, Inc. —Rockville, MD
- $47,000 - $60,000 a year
- Weekends as needed
- Research
- Mid-level
- Supervising experience
- Health insurance
- Dental insurance
Quick Apply
Medical Laboratory Scientist II
Quest Diagnostics —Chantilly, VA
- $35.78 - $48.06 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
- Employee stock purchase plan
- Disability insurance
Quick Apply
21h
Associate Scientist, Bioanalytical Lab
Meso Scale Diagnostics, LLC. —Gaithersburg, MD
- $78,100 - $116,200 a year
- Maintenance
- Mid-level
- Master's degree
- Paid parental leave
- AD&D insurance
Quick Apply

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Associate Director, AS&T Lifecycle Management (Chemical Method Expert)

BioNTech AG -
Gaithersburg, MD

Apply Now

Job Details

Full-time
$146,300 - $234,100 a year

Benefits

Health savings account
AD&D insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Loan assistance
Life insurance
Pet insurance

Qualifications

Biology
FDA submissions
Statistics
Infrared Spectroscopy (IR)
Pharmaceutical laboratory environment
Defect analysis
High-performance liquid chromatographs
Biotechnology
Investigational new drug (IND) applications
Statistical analysis
ICH guidelines
Laboratory regulatory affairs
Pharmaceutical company experience
Pharmaceutical analysis
Pharmacy
Mass spectrometers (MS)
Chemistry, manufacturing & controls
Chemistry
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Verification of laboratory test methods
Quality control experience within pharmaceutical industry
International corporation experience
GMP for research safety and compliance
Root cause analysis
Senior level
Cross-functional collaboration
Test validation method
Cross-functional communication
Nuclear magnetic resonance (NMR) spectroscopy

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
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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Apply Now

Refine Your Search

medical laboratory scientist jobs in gaithersburg, md

Associate Director, AS&T Lifecycle Management (Chemical Method Expert)

Associate Director, AS&T Lifecycle Management (Biological Method Expert)

Medical Laboratory Scientist I

Scientist I/II - Bioconjugation

Public Health Laboratory Scientist I

Medical Lab Scientist I - Part - time - DCMC

Clinical Laboratory Scientist

Medical Laboratory Scientist II - Core Lab Night Shift

Medical Laboratory Scientist 1

Biologist I

Biological Scientist

Assistant Scientist, Biologist

Medical Technologist PRN - Microbiology

Scientist

Lab Supervisor 1 - Analytical Development

Scientist 2 - Stability

Associate Scientist

Laboratory Technician / Scientist / Manager

Medical Laboratory Scientist II

Associate Scientist, Bioanalytical Lab

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