H-1B Visa Biotech Jobs
Biotech is one of the most active H-1B visa sponsoring sectors in the U.S., with drug development, genomics, and clinical research roles consistently qualifying as specialty occupations. Employers from large pharma to early-stage biologics companies file LCAs regularly, making it a strong market for H-1B holders at every career stage.
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Get Access To All JobsAt Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Job Posting: Biotech Network Advisor, Quality Assurance
Position Description:
The Quality Assurance Advisor reports directly to the Quality Executive Director and supports the Biotech Network Sites for capital project activities and supplier quality. This position will be responsible for supporting the design, engineering, commissioning, and qualification of facilities, utilities, and equipment. The role ensures compliance with the requirements of all relevant regulatory agencies. You will be responsible for advising and assisting in the review of commissioning, qualification, and validation documents supporting capital project execution. The Quality Assurance Advisor will provide leadership and guidance to other Quality staff engaged in capital project and technology transfer activities, and support establishment/continual improvement of local business processes and procedures that align with Elanco operational standards across the Biotech Network. The role will also provide support to all sites in the network related to materials management and the supplier quality program.
Your Responsibilities:
- Act as the Quality Assurance representative in all local and major capital project activities within the Biotech Network.
- Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to: definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, and support for process validation.
- Assist in defining needs for Quality Control testing laboratories and compliance needs of the same.
- Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and influence/align with local and global business partners to ensure compliant delivery.
- Act as a QA subject matter expert in project teams and committees.
- Review, revise, and approve relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, safety and environmental assessments, validation plans/protocols.
- Support the creation, review, and implementation of quality standards and procedures for new facilities, utilities, equipment, and manufacturing processes. Establish and continually improve local business processes and systems in alignment with Elanco operational standards across the Biotech Network.
- Support computer system validation activities including review and approval of validation protocols and reports.
- Partner with R&D, Manufacturing, Engineering, Supply Chain, and TSMS to support the successful technology transfer of new mAb products.
- Review and approve change management plans and complete/verify corresponding action items.
- Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and technical success.
- Provide leadership and guidance to Quality staff (internal and/or external) engaged in capital project and technology transfer activities.
- Demonstrate strict adherence to relevant local, state, and federal requirements, cGMP standards, and Elanco policies and procedures. Exemplify "Safety First and Quality Always" mind-set.
- Attend and complete necessary training as required in order to stay current with industry standards.
- Provide guidance on adherence to requirements related to materials management and supplier quality. Assist in the development and maintenance of functional standards and procedures.
Minimum Qualifications:
- Bachelor's degree in a science or engineering discipline.
- 10+ years' experience in quality, engineering, or validation roles in a regulated industry.
- Thorough knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU regulations as related to manufacturing, quality, and release activities.
- Strong leadership, team building, organizational, and interpersonal skills. High attention to detail.
- Knowledge and understanding of biopharmaceutical and pharmaceutical operations.
- Analytical Skills: Highly analytical and strong advocate for process improvement.
- Excellent written and verbal communication skills with internal and external customers, peers, and managers.
- Excellent computer, documentation, and organizational skills required.
- Demonstrated ability to work collaboratively and across multiple departments and organization levels. Experience with Microsoft Office (Microsoft Word, Excel, PowerPoint, and Outlook).
What will give you a Competitive Edge (Preferred Qualifications):
- MSc or PhD in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or a related discipline.
- Management/supervisory experience.
- Experience in tech transfer, optimization, and validation of analytical methods for characterization of biological products (e.g., mAbs, recombinant proteins, vaccines).
- Experience in materials management for USDA, FDA, or EMA regulated industries.
- Experience in operational excellence and root cause investigation procedures.
- Experience in Quality Control testing and environments.
- Experience in user specifications and design qualifications.
- Experience in equipment and facility commissioning, qualification, and validation procedures.
- Demonstrated success leading cross-functional teams/projects.
- Experience with SAP, JMP, Veeva Vault.
- Excellent technical writing skills.
- Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.
- International experience is highly valued.
Additional Information:
- This is a full-time, permanent, salaried, on-site position (supporting Biotech Network Sites).
- Minimal travel requirements (< 30%).
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Job Posting: Biotech Network Advisor, Quality Assurance
Position Description:
The Quality Assurance Advisor reports directly to the Quality Executive Director and supports the Biotech Network Sites for capital project activities and supplier quality. This position will be responsible for supporting the design, engineering, commissioning, and qualification of facilities, utilities, and equipment. The role ensures compliance with the requirements of all relevant regulatory agencies. You will be responsible for advising and assisting in the review of commissioning, qualification, and validation documents supporting capital project execution. The Quality Assurance Advisor will provide leadership and guidance to other Quality staff engaged in capital project and technology transfer activities, and support establishment/continual improvement of local business processes and procedures that align with Elanco operational standards across the Biotech Network. The role will also provide support to all sites in the network related to materials management and the supplier quality program.
Your Responsibilities:
- Act as the Quality Assurance representative in all local and major capital project activities within the Biotech Network.
- Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to: definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, and support for process validation.
- Assist in defining needs for Quality Control testing laboratories and compliance needs of the same.
- Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and influence/align with local and global business partners to ensure compliant delivery.
- Act as a QA subject matter expert in project teams and committees.
- Review, revise, and approve relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, safety and environmental assessments, validation plans/protocols.
- Support the creation, review, and implementation of quality standards and procedures for new facilities, utilities, equipment, and manufacturing processes. Establish and continually improve local business processes and systems in alignment with Elanco operational standards across the Biotech Network.
- Support computer system validation activities including review and approval of validation protocols and reports.
- Partner with R&D, Manufacturing, Engineering, Supply Chain, and TSMS to support the successful technology transfer of new mAb products.
- Review and approve change management plans and complete/verify corresponding action items.
- Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and technical success.
- Provide leadership and guidance to Quality staff (internal and/or external) engaged in capital project and technology transfer activities.
- Demonstrate strict adherence to relevant local, state, and federal requirements, cGMP standards, and Elanco policies and procedures. Exemplify "Safety First and Quality Always" mind-set.
- Attend and complete necessary training as required in order to stay current with industry standards.
- Provide guidance on adherence to requirements related to materials management and supplier quality. Assist in the development and maintenance of functional standards and procedures.
Minimum Qualifications:
- Bachelor's degree in a science or engineering discipline.
- 10+ years' experience in quality, engineering, or validation roles in a regulated industry.
- Thorough knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU regulations as related to manufacturing, quality, and release activities.
- Strong leadership, team building, organizational, and interpersonal skills. High attention to detail.
- Knowledge and understanding of biopharmaceutical and pharmaceutical operations.
- Analytical Skills: Highly analytical and strong advocate for process improvement.
- Excellent written and verbal communication skills with internal and external customers, peers, and managers.
- Excellent computer, documentation, and organizational skills required.
- Demonstrated ability to work collaboratively and across multiple departments and organization levels. Experience with Microsoft Office (Microsoft Word, Excel, PowerPoint, and Outlook).
What will give you a Competitive Edge (Preferred Qualifications):
- MSc or PhD in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or a related discipline.
- Management/supervisory experience.
- Experience in tech transfer, optimization, and validation of analytical methods for characterization of biological products (e.g., mAbs, recombinant proteins, vaccines).
- Experience in materials management for USDA, FDA, or EMA regulated industries.
- Experience in operational excellence and root cause investigation procedures.
- Experience in Quality Control testing and environments.
- Experience in user specifications and design qualifications.
- Experience in equipment and facility commissioning, qualification, and validation procedures.
- Demonstrated success leading cross-functional teams/projects.
- Experience with SAP, JMP, Veeva Vault.
- Excellent technical writing skills.
- Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.
- International experience is highly valued.
Additional Information:
- This is a full-time, permanent, salaried, on-site position (supporting Biotech Network Sites).
- Minimal travel requirements (< 30%).
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
See all H-1B Visa Biotech Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Biotech
Verify your degree field matches the role
Biotech roles often require a degree in molecular biology, biochemistry, or a directly related field. A general biology or chemistry degree may trigger an RFE if the job description demands a specific discipline. Confirm the match before applying.
Filter employers by LCA filing history
Use Migrate Mate to identify biotech companies with active H-1B LCA filings for your specific role type. Prioritizing employers with consistent filing history cuts the time you spend on companies that have never sponsored.
Target STEM-classified biotech job codes
Biotech roles tied to SOC codes in life sciences and biological research carry stronger specialty occupation standing. Check O*NET to confirm the job zone and degree requirements for the specific title your offer uses before the I-129 is filed.
Ask about cap-exempt facility affiliations
Some biotech roles at research hospitals, nonprofit institutes, or university-affiliated labs qualify for cap-exempt H-1B status, bypassing the lottery entirely. Ask hiring managers directly whether the entity files under a cap-exempt designation.
Confirm LCA wage level before accepting an offer
DOL requires the LCA to certify a prevailing wage at or above the level for your role and location. Use the OFLC Wage Search to check the Level I through Level IV range for your SOC code before negotiating compensation.
Build a credential portfolio for RFE readiness
Biotech H-1B petitions draw RFEs when degree-to-role alignment isn't obvious. Compile transcripts, published research, patents, and any credential evaluations now so your employer's attorney can respond to USCIS within the 87-day window without scrambling.
H-1B Visa Biotech: Frequently Asked Questions
Do biotech roles qualify as H-1B specialty occupations?
Most professional biotech roles qualify because they require at minimum a bachelor's degree in a specific field such as biochemistry, molecular biology, or biomedical engineering. USCIS evaluates the job description and the degree requirement, not the industry label. Roles where any bachelor's degree is acceptable, regardless of field, are harder to qualify. Your employer's attorney should document the degree-field connection explicitly in the I-129 petition.
How do I find biotech employers who actively sponsor H-1B visas?
Migrate Mate shows verified LCA filing history by employer and role, so you can see which biotech companies have sponsored H-1B workers in titles similar to yours. DOL publishes LCA disclosure data quarterly, and Migrate Mate surfaces that data by occupation code. This is more reliable than relying on a company's careers page, which rarely discloses sponsorship policy upfront.
Can I switch biotech employers after my H-1B is approved?
Yes. Under AC21 portability, you can change to a new biotech employer in the same or a similar occupational classification once your I-140 has been approved for 180 days or more. Outside of that, your new employer must file an H-1B transfer petition before you start work. You can begin working for the new employer as soon as USCIS receives the transfer petition, not only after approval.
Does working at a biotech startup affect H-1B sponsorship?
Startups can sponsor H-1B visas, but USCIS scrutinizes the employer-employee relationship more closely when the petitioner is small or early-stage. The company must demonstrate it can pay the prevailing wage and that the role constitutes genuine specialty occupation work. Startups where you hold equity or have significant control over your own work direction can face additional RFEs about the nature of the employment relationship.
What happens to my H-1B status if my biotech employer is acquired?
If the acquiring company assumes the liabilities and assets of your employer through a successor-in-interest acquisition, your H-1B status typically continues without a new petition, provided your job duties and location don't change materially. However, if the acquisition is structured as an asset purchase rather than a merger, a new I-129 may be required. USCIS guidance on successor-in-interest applies, and your employer's attorney should confirm which scenario applies before the deal closes.