STEM OPT Technical Lead Jobs
Technical Lead roles qualify for the 24-month STEM OPT extension when your degree falls under an eligible CIP code and your employer is enrolled in E-Verify. With up to 36 months of total OPT work authorization, you have real runway to build team leadership experience while pursuing long-term sponsorship.
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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.
Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team to help build a state-of-the-art facility and Technical System from the ground up, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description:
Technical Lead – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical leadership and oversight to clinical and commercialization activities of gene therapy product at the Lebanon Advanced Therapies (LP2) site. The scope of the role includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing.
The TS/MS Technical Lead can be involved with clinical trials and supports all commercialization activities up to submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and LP2 commercialization procedures.
The TS/MS Technical Lead works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.
Key Objectives/Deliverables
- Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization.
- Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products.
- Support identification and development of new manufacturing technologies and processes to support commercialization.
- Lead risk management activities as it pertains to new products (FMEA).
- Own Tech Transfer strategy for the manufacturing site.
- Ensure that an accurate instruction set (eBRs and procedures) and PFD describe the process and control strategy for new products.
- Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications.
- Understand, justify, and document the process validation strategy for new products.
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: tech transfer risk assessments / plans / reports, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, PFDs, etc.
- Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections.
- Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in LP2.
- Serve as technical interface with development.
- Communicate effectively with process team members, development colleagues, tech transfer team members, and other parties.
- Identify opportunities for best practices and implement improvements to manufacturing technology.
- Own and prepare Annual Product Reviews, etc.
Basic Requirements:
- B.S. in Biotechnology, Biochemistry or related quantitative field
- 3+ years of experience in pharmaceutical/biotech manufacturing industry
- 1+ year of experience with new product submission and filing
Additional Preferences:
- Experience with product commercialization
- Demonstrated experience managing and collaborating with CMOs
- Demonstrated technical capability with high productivity
- Proven track record of curiosity with learning agility
- Self-starter with high initiative and data-driven approach to problem-solving
- Demonstrated strong interpersonal skills
- Demonstrated strong verbal and written communication skills
- Demonstrated adaptability and flexibility to working in different environments, teams etc.
- Demonstrated ability to participate in and facilitate decision-making
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 $129,000 - $189,200. 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.
Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team to help build a state-of-the-art facility and Technical System from the ground up, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description:
Technical Lead – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical leadership and oversight to clinical and commercialization activities of gene therapy product at the Lebanon Advanced Therapies (LP2) site. The scope of the role includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing.
The TS/MS Technical Lead can be involved with clinical trials and supports all commercialization activities up to submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and LP2 commercialization procedures.
The TS/MS Technical Lead works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.
Key Objectives/Deliverables
- Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization.
- Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products.
- Support identification and development of new manufacturing technologies and processes to support commercialization.
- Lead risk management activities as it pertains to new products (FMEA).
- Own Tech Transfer strategy for the manufacturing site.
- Ensure that an accurate instruction set (eBRs and procedures) and PFD describe the process and control strategy for new products.
- Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications.
- Understand, justify, and document the process validation strategy for new products.
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: tech transfer risk assessments / plans / reports, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, PFDs, etc.
- Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections.
- Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in LP2.
- Serve as technical interface with development.
- Communicate effectively with process team members, development colleagues, tech transfer team members, and other parties.
- Identify opportunities for best practices and implement improvements to manufacturing technology.
- Own and prepare Annual Product Reviews, etc.
Basic Requirements:
- B.S. in Biotechnology, Biochemistry or related quantitative field
- 3+ years of experience in pharmaceutical/biotech manufacturing industry
- 1+ year of experience with new product submission and filing
Additional Preferences:
- Experience with product commercialization
- Demonstrated experience managing and collaborating with CMOs
- Demonstrated technical capability with high productivity
- Proven track record of curiosity with learning agility
- Self-starter with high initiative and data-driven approach to problem-solving
- Demonstrated strong interpersonal skills
- Demonstrated strong verbal and written communication skills
- Demonstrated adaptability and flexibility to working in different environments, teams etc.
- Demonstrated ability to participate in and facilitate decision-making
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 $129,000 - $189,200. 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 84+ STEM OPT Technical Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new STEM OPT Technical Lead Jobs.
Get Access To All JobsTips for Finding STEM OPT Authorization in Technical Lead
Verify your CIP code before applying
Pull your degree's CIP code from your DSO and cross-reference it against the official STEM OPT CIP code list maintained by ICE. Computer science, electrical engineering, and information systems degrees are commonly approved, but adjacent fields like MIS or applied math can vary by institution.
Filter job listings by E-Verify status
Before submitting any application, confirm the employer is actively enrolled in E-Verify using the E-Verify employer search. A Technical Lead offer from a non-enrolled employer cannot support your STEM OPT extension, regardless of how strong the offer looks.
Target companies with existing H-1B filing history
Use Migrate Mate to search Technical Lead roles filtered by employers with documented visa sponsorship activity. DOL Labor Condition Application data shows which companies have filed for similar roles, so you're targeting employers already familiar with the process.
Build your I-983 training plan around leadership competencies
USCIS requires a completed I-983 training plan before your STEM OPT extension is authorized. For Technical Lead roles, map your learning objectives to specific engineering or systems competencies, not just management tasks, to satisfy the practical training requirement for a STEM-designated position.
Negotiate offer timing around your OPT expiration
If your initial 12-month OPT expires while an H-1B visa petition is pending, cap-gap protection extends your authorization through September 30 of that fiscal year. Structure your start date and onboarding timeline so you're not caught between your OPT end date and a pending STEM extension approval.
Check prevailing wage requirements for your level
Technical Lead positions span multiple DOL wage levels depending on supervisory scope and years of experience. Run your target job title and metro area through the OFLC Wage Search to understand where your offer should land before you enter salary negotiations with a sponsoring employer.
Frequently Asked Questions
Does a Technical Lead role qualify for the STEM OPT extension?
Yes, if your degree is in a STEM-designated field with an eligible CIP code and the role directly applies that training. Technical Lead positions in software engineering, systems architecture, or data infrastructure typically satisfy the practical training requirement. Your DSO confirms eligibility based on your specific degree and the employer's I-983 training plan, not just the job title.
What E-Verify requirement applies to my STEM OPT employer?
Your employer must be actively enrolled in E-Verify before your STEM OPT extension can be authorized. This applies to every employer in the chain, including the direct hiring entity, not a staffing intermediary. You can confirm enrollment through E-Verify's employer search tool. If the employer isn't enrolled, your DSO cannot approve the I-983 and the extension cannot proceed.
How do I complete the I-983 training plan for a Technical Lead position?
The I-983 requires you and your employer to define specific learning objectives tied to your STEM degree. For Technical Lead roles, this means documenting engineering skill development, not just team management responsibilities. Both you and a company supervisor sign the form before your DSO submits the STEM OPT application. USCIS can audit I-983 compliance, so the training objectives need to reflect your actual day-to-day technical work.
What happens to my STEM OPT authorization if my employer loses E-Verify enrollment?
If your employer's E-Verify enrollment lapses after your STEM OPT extension is approved, you must report the change to your DSO within five days and begin finding a new qualifying employer. Your existing extension authorization doesn't automatically terminate, but you cannot continue working for an employer who is no longer enrolled. USCIS treats continued employment under those conditions as a violation of your status.
Where can I find Technical Lead jobs at employers already set up for STEM OPT?
Migrate Mate filters Technical Lead listings by employers with active E-Verify enrollment and documented visa sponsorship history, so you're not spending time on companies that can't support your extension. Searching there lets you focus on roles where the employer already understands the I-983 process and has filed Labor Condition Applications for similar positions before.