STEM OPT Biochemist Jobs
Biochemist roles in pharmaceuticals, biotech, and research institutions are strong fits for F-1 students with STEM degrees in biochemistry, molecular biology, or related fields. Your STEM OPT extension adds 24 months of work authorization, giving you up to 36 months total, as long as your employer is enrolled in E-Verify.
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Get Access To All JobsAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Position Overview:
The BRD Analytical Development team is seeking an Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). This role is primarily laboratory-based, with responsibility for developing and qualifying analytical methods for characterization, release, and stability testing of drug substance and drug product across the genetic medicines portfolio, spanning early-phase IND-enabling studies through commercial BLA readiness. The successful candidate will have deep hands-on expertise in chromatographic and electrophoretic separations and will contribute to GMP analytical activities within a cross-functional CMC development environment.
Key Responsibilities:
- Design, develop, optimize, and execute chromatographic separations methods including anion-exchange (AEX/IEX), size-exclusion chromatography (SEC), and ion-pairing reversed-phase HPLC (IP-RP-HPLC) for purity, integrity, and quality attribute assessment of genetic medicine drug substance and drug product.
- Develop and execute capillary electrophoresis methods (CE-SDS, cIEF) for size- and charge-based characterization of drug substance components.
- Develop, qualify, and validate robust analytical methods for the identification and quantitation of process-related residual impurities in support of product quality and regulatory requirements.
- Apply separations-based techniques to support DS and DP release, characterization, and stability programs across genetic medicine modalities.
- Troubleshoot chromatographic and electrophoretic method performance issues including resolution, peak shape, carryover, and reproducibility, and implement appropriate corrective strategies.
- Evaluate and implement fit-for-purpose separations technologies to advance the analytical control strategy for genetic medicine programs.
- Contribute to analytical control strategies for genetic medicine drug substance and drug product, including identification of critical quality attributes (CQAs) and appropriate test methods.
- Support assay qualification, verification, and validation activities per ICH Q2(R2) and applicable regulatory expectations for genetic medicine and ATMP products.
- Contribute analytical data and technical content supporting stability study design and execution across DS and DP matrices.
- Ensure all analytical work is conducted in compliance with GMP, GLP, and applicable HSE requirements; maintain awareness of internal quality procedures and regulatory expectations.
- Author and review analytical methods, protocols, qualification/validation reports, method transfer packages, and technical summaries with high scientific accuracy and clarity.
- Maintain rigorous electronic laboratory notebook (ELN) practices and documentation standards for all experimental records.
- Support technology transfer of analytical methods to CRO/CMO partners and Lilly manufacturing sites; participate in cross-site qualification or co-validation studies.
- Provide technical input during interactions with external analytical partners; review and interpret externally generated data packages.
- Maintain awareness of emerging analytical technologies, regulatory guidance updates, and industry best practices relevant to genetic medicine analytical development.
- Collaborate within cross-functional project teams including process development, quality, regulatory affairs, and clinical operations to deliver analytical support for clinical trials and regulatory submissions.
- Communicate analytical results, timelines, and technical challenges clearly to team members and project stakeholders in oral and written formats.
- Contribute to a positive, inclusive, and scientifically rigorous team culture; share technical knowledge and support the growth of colleagues.
Basic Qualifications:
- Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 0-5+ years of relevant pharmaceutical or biotech industry experience; or
- M.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 6+ years of relevant pharmaceutical or biotech industry experience; or
- B.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 12+ years of relevant pharmaceutical or biotech industry experience.
- Demonstrated hands-on laboratory proficiency with HPLC/UHPLC platforms and chromatographic separations (AEX/IEX, SEC, IP-RP-HPLC) applied to biopharmaceutical drug substance or nucleic acid analytes in a pharmaceutical or biotech development context.
- Practical experience with capillary electrophoresis platforms (CE-SDS and/or cIEF) for biopharmaceutical characterization in a pharmaceutical or biotech development context.
- Experience with method development, optimization, and qualification/validation of separations-based methods in a pharmaceutical or biotech development context.
- Demonstrated ability to independently design experiments, generate high-quality data, and interpret results in a development environment.
- Familiarity with GMP/GLP requirements and their application to analytical method development and documentation.
Additional Skills & Preferences:
- Experience applying separations methods to genetic medicine or ATMP products, including viral vector purity profiling, empty/full capsid ratio assessment, or nucleic acid payload characterization.
- Familiarity with orthogonal characterization platforms such as flow cytometry or mass spectrometry for genetic medicine product analysis.
- Knowledge of FDA/EMA regulatory expectations for separations-based CQA testing in genetic medicine CMC submissions.
- Experience supporting analytical aspects of IND or BLA/MAA submissions, including contributing to Module 3 analytical sections.
- Experience with immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing.
- Experience with method transfer to external CRO/CMO organizations and participation in inter-laboratory comparability studies.
- Proficiency with electronic laboratory notebooks (e.g., Benchling) and data management systems.
- Effective oral and written communication skills; ability to present complex technical information to multidisciplinary audiences.
- Demonstrated ability to manage multiple priorities and work productively in a fast-paced, collaborative team environment.
Additional Information:
- Travel: 0 to 15%
- Potential exposure to chemicals, allergens, and loud noises.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $244,200.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Position Overview:
The BRD Analytical Development team is seeking an Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). This role is primarily laboratory-based, with responsibility for developing and qualifying analytical methods for characterization, release, and stability testing of drug substance and drug product across the genetic medicines portfolio, spanning early-phase IND-enabling studies through commercial BLA readiness. The successful candidate will have deep hands-on expertise in chromatographic and electrophoretic separations and will contribute to GMP analytical activities within a cross-functional CMC development environment.
Key Responsibilities:
- Design, develop, optimize, and execute chromatographic separations methods including anion-exchange (AEX/IEX), size-exclusion chromatography (SEC), and ion-pairing reversed-phase HPLC (IP-RP-HPLC) for purity, integrity, and quality attribute assessment of genetic medicine drug substance and drug product.
- Develop and execute capillary electrophoresis methods (CE-SDS, cIEF) for size- and charge-based characterization of drug substance components.
- Develop, qualify, and validate robust analytical methods for the identification and quantitation of process-related residual impurities in support of product quality and regulatory requirements.
- Apply separations-based techniques to support DS and DP release, characterization, and stability programs across genetic medicine modalities.
- Troubleshoot chromatographic and electrophoretic method performance issues including resolution, peak shape, carryover, and reproducibility, and implement appropriate corrective strategies.
- Evaluate and implement fit-for-purpose separations technologies to advance the analytical control strategy for genetic medicine programs.
- Contribute to analytical control strategies for genetic medicine drug substance and drug product, including identification of critical quality attributes (CQAs) and appropriate test methods.
- Support assay qualification, verification, and validation activities per ICH Q2(R2) and applicable regulatory expectations for genetic medicine and ATMP products.
- Contribute analytical data and technical content supporting stability study design and execution across DS and DP matrices.
- Ensure all analytical work is conducted in compliance with GMP, GLP, and applicable HSE requirements; maintain awareness of internal quality procedures and regulatory expectations.
- Author and review analytical methods, protocols, qualification/validation reports, method transfer packages, and technical summaries with high scientific accuracy and clarity.
- Maintain rigorous electronic laboratory notebook (ELN) practices and documentation standards for all experimental records.
- Support technology transfer of analytical methods to CRO/CMO partners and Lilly manufacturing sites; participate in cross-site qualification or co-validation studies.
- Provide technical input during interactions with external analytical partners; review and interpret externally generated data packages.
- Maintain awareness of emerging analytical technologies, regulatory guidance updates, and industry best practices relevant to genetic medicine analytical development.
- Collaborate within cross-functional project teams including process development, quality, regulatory affairs, and clinical operations to deliver analytical support for clinical trials and regulatory submissions.
- Communicate analytical results, timelines, and technical challenges clearly to team members and project stakeholders in oral and written formats.
- Contribute to a positive, inclusive, and scientifically rigorous team culture; share technical knowledge and support the growth of colleagues.
Basic Qualifications:
- Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 0-5+ years of relevant pharmaceutical or biotech industry experience; or
- M.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 6+ years of relevant pharmaceutical or biotech industry experience; or
- B.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 12+ years of relevant pharmaceutical or biotech industry experience.
- Demonstrated hands-on laboratory proficiency with HPLC/UHPLC platforms and chromatographic separations (AEX/IEX, SEC, IP-RP-HPLC) applied to biopharmaceutical drug substance or nucleic acid analytes in a pharmaceutical or biotech development context.
- Practical experience with capillary electrophoresis platforms (CE-SDS and/or cIEF) for biopharmaceutical characterization in a pharmaceutical or biotech development context.
- Experience with method development, optimization, and qualification/validation of separations-based methods in a pharmaceutical or biotech development context.
- Demonstrated ability to independently design experiments, generate high-quality data, and interpret results in a development environment.
- Familiarity with GMP/GLP requirements and their application to analytical method development and documentation.
Additional Skills & Preferences:
- Experience applying separations methods to genetic medicine or ATMP products, including viral vector purity profiling, empty/full capsid ratio assessment, or nucleic acid payload characterization.
- Familiarity with orthogonal characterization platforms such as flow cytometry or mass spectrometry for genetic medicine product analysis.
- Knowledge of FDA/EMA regulatory expectations for separations-based CQA testing in genetic medicine CMC submissions.
- Experience supporting analytical aspects of IND or BLA/MAA submissions, including contributing to Module 3 analytical sections.
- Experience with immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing.
- Experience with method transfer to external CRO/CMO organizations and participation in inter-laboratory comparability studies.
- Proficiency with electronic laboratory notebooks (e.g., Benchling) and data management systems.
- Effective oral and written communication skills; ability to present complex technical information to multidisciplinary audiences.
- Demonstrated ability to manage multiple priorities and work productively in a fast-paced, collaborative team environment.
Additional Information:
- Travel: 0 to 15%
- Potential exposure to chemicals, allergens, and loud noises.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $244,200.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
See all STEM OPT Biochemist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new STEM OPT Biochemist Jobs.
Get Access To All JobsTips for Finding STEM OPT Authorization in Biochemist
Verify your CIP code before applying
Your degree's Classification of Instructional Programs code determines STEM OPT eligibility. Biochemistry typically falls under CIP 26.0202. Confirm your program's code with your DSO before you apply, so there are no surprises at the I-983 stage.
Target E-Verify enrolled biotech employers
Your employer must be enrolled in E-Verify for your STEM OPT extension to be valid. Search the E-Verify employer search tool to confirm enrollment before accepting an offer, not after you've already signed.
Use Migrate Mate to find STEM OPT biochemist roles
Many biochemist postings don't explicitly state E-Verify enrollment. Migrate Mate filters for employers who meet STEM OPT requirements, so you're applying to roles where the authorization pathway is already confirmed.
Build a training plan tied to biochemist duties
Your I-983 must map specific learning objectives to your actual job duties. For biochemist roles, connect tasks like assay development or data analysis to the STEM knowledge your degree covers. Generic plans get rejected by DSOs.
Check prevailing wage before negotiating your offer
Your employer's LCA must certify a wage at or above the prevailing wage for your role and location. Run the OFLC Wage Search using your SOC code for biochemists before you negotiate, so you know the DOL floor going in.
Frequently Asked Questions
Does my biochemistry degree qualify me for the STEM OPT extension?
It depends on your program's CIP code, not just the degree title. Biochemistry programs coded under CIP 26.02 are on the STEM Designated Degree Program List maintained by DHS. If your degree is in a related field like molecular biology or chemical biology, check the exact code with your DSO. USCIS does not approve extensions for programs not on the official list.
What does the I-983 training plan require for a biochemist position?
Your I-983 must describe specific goals, learning objectives, and how the biochemist role relates to your STEM degree. For lab or research positions, you'll need to connect job duties, such as protein characterization or cell culture work, to coursework or skills from your program. Your employer must sign it, and your DSO must approve it before your STEM OPT extension begins.
How do I confirm a biochemist employer is enrolled in E-Verify?
E-Verify maintains a public employer search tool where you can look up any company by name to confirm active enrollment. Do this before accepting an offer. An employer who isn't enrolled cannot legally employ you on STEM OPT, and enrollment can't be retroactively applied after your start date.
How do I find biochemist employers who accept STEM OPT students?
Migrate Mate is built specifically for STEM OPT job seekers and surfaces biochemist roles at employers already enrolled in E-Verify. Most job postings don't advertise E-Verify status or OPT compatibility, which makes filtering through standard searches unreliable. Migrate Mate removes that guesswork by surfacing roles where the core STEM OPT requirements are already met.
What happens to my STEM OPT authorization if my H-1B is selected in the lottery?
If your STEM OPT is still valid when your H-1B petition is filed and selected, cap-gap rules under USCIS automatically extend your work authorization through September 30 of that year. Your employer must remain E-Verify enrolled throughout the cap-gap period. If your OPT expires before your H-1B start date and you're not in cap-gap, you must stop working.