TN Visa Product Director Jobs
Product Director roles qualify for TN visa sponsorship under the USMCA's Management Consultant and Engineer categories, depending on your specialization and how the employer defines the role. Canadian citizens can enter at the border with employer documents. Mexican citizens apply at a U.S. consulate. A bachelor's degree in a relevant field is required.
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Get Access To All JobsAt Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral drug products of various modalities spanning from small molecules, peptides, oligopeptides, bioconjugates, proteins, vaccines to monoclonal antibodies, etc. The organization is also committed to the development of genetic medicines which includes active investments in AAV, LVV, mRNA, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new technology capability to support complex drug product commercialization in different drug product presentations such as co-formulation, high concentration, and long-acting presentations, etc. in different devices as the combination products.
We are seeking a highly motivated process engineer leader with extensive industry experience and knowledge in parenteral drug product process development from compounding to fill/finish to advance Lilly portfolio from clinical to commercialization. This position is located at Lilly’s tech center, next to Lilly’s headquarter in Indianapolis. This position seeks a candidate with extensive industry experience in process development. This candidate would drive cross-functional collaboration with Lilly internal and external key stakeholders to advance portfolio assets. If you are interested in developing novel medicine to serve millions and millions of patients, you should consider joining our diverse and high-performing team.
Responsibilities:
- Lead talented scientists to design and execute complex process studies to define clinical and commercial manufacturing process for various parenteral drug products. Mentor scientists to improve their scientific understanding in study design capabilities.
- Lead the efforts to design the process development and characterization of various new modalities, especially novel drug product presentations for late-stage process development, including assessing and mitigating process risks during scale-up via a deep understanding of in-process and final product critical quality attributes and critical process parameters.
- Drive collaboration with Lilly’s internal and external key stakeholders to address complex tech transfer challenges across sites, including both internal and external manufacturing organizations, and work closely with stakeholders to ensure the integration of novel excipients and technologies into CMC development timeline and appropriate pathway for regulatory submission.
- Drive collaboration with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author and review tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.
- Ensure consistency in technical deliverables and documentation across transfers.
- Cross-Functional Collaboration: Represent BRD organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline along with key deliverables to meet the requirements for regulatory submission.
- External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
- Innovation: Initiate and drive innovation to tackle complex new modalities process performance and product quality for various new modalities as well as new technologies. Actively involve and contribute to BRD and cross-functional innovation to support PRD strategy decision. Present scientific findings and present to internal and external stakeholders and leverage the innovations to advance Lilly portfolio.
Basic Requirements:
- Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences are highly preferred with a minimum of 7 years of industry experience directly in parenteral drug product process development from bulk drug product compounding to fill/finish.
- Extensive experience and knowledge with process development of parenteral drug products such as peptides, ADCs, fusion proteins, mAbs and vaccines manufacturing process is required.
- Large scale process development experience from clinical to commercialization is required.
- Hands-on experience in designing and optimizing manufacturing processes including large scale compounding, filtration and fill/finish is required.
- Strong knowledge and experience with regulatory submissions (INDs, NDAs and/or BLAs of parenteral drug products is required.
- Strong understanding of cGMP requirements, ICH and regulatory guidelines is a must.
Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with a lab environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in a laboratory environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $239,800.
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, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral drug products of various modalities spanning from small molecules, peptides, oligopeptides, bioconjugates, proteins, vaccines to monoclonal antibodies, etc. The organization is also committed to the development of genetic medicines which includes active investments in AAV, LVV, mRNA, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new technology capability to support complex drug product commercialization in different drug product presentations such as co-formulation, high concentration, and long-acting presentations, etc. in different devices as the combination products.
We are seeking a highly motivated process engineer leader with extensive industry experience and knowledge in parenteral drug product process development from compounding to fill/finish to advance Lilly portfolio from clinical to commercialization. This position is located at Lilly’s tech center, next to Lilly’s headquarter in Indianapolis. This position seeks a candidate with extensive industry experience in process development. This candidate would drive cross-functional collaboration with Lilly internal and external key stakeholders to advance portfolio assets. If you are interested in developing novel medicine to serve millions and millions of patients, you should consider joining our diverse and high-performing team.
Responsibilities:
- Lead talented scientists to design and execute complex process studies to define clinical and commercial manufacturing process for various parenteral drug products. Mentor scientists to improve their scientific understanding in study design capabilities.
- Lead the efforts to design the process development and characterization of various new modalities, especially novel drug product presentations for late-stage process development, including assessing and mitigating process risks during scale-up via a deep understanding of in-process and final product critical quality attributes and critical process parameters.
- Drive collaboration with Lilly’s internal and external key stakeholders to address complex tech transfer challenges across sites, including both internal and external manufacturing organizations, and work closely with stakeholders to ensure the integration of novel excipients and technologies into CMC development timeline and appropriate pathway for regulatory submission.
- Drive collaboration with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author and review tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.
- Ensure consistency in technical deliverables and documentation across transfers.
- Cross-Functional Collaboration: Represent BRD organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline along with key deliverables to meet the requirements for regulatory submission.
- External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
- Innovation: Initiate and drive innovation to tackle complex new modalities process performance and product quality for various new modalities as well as new technologies. Actively involve and contribute to BRD and cross-functional innovation to support PRD strategy decision. Present scientific findings and present to internal and external stakeholders and leverage the innovations to advance Lilly portfolio.
Basic Requirements:
- Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences are highly preferred with a minimum of 7 years of industry experience directly in parenteral drug product process development from bulk drug product compounding to fill/finish.
- Extensive experience and knowledge with process development of parenteral drug products such as peptides, ADCs, fusion proteins, mAbs and vaccines manufacturing process is required.
- Large scale process development experience from clinical to commercialization is required.
- Hands-on experience in designing and optimizing manufacturing processes including large scale compounding, filtration and fill/finish is required.
- Strong knowledge and experience with regulatory submissions (INDs, NDAs and/or BLAs of parenteral drug products is required.
- Strong understanding of cGMP requirements, ICH and regulatory guidelines is a must.
Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with a lab environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in a laboratory environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $239,800.
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 TN Visa Product Director Jobs
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Get Access To All JobsTips for Finding TN Visa Sponsorship in Product Director
Frame your credentials around USMCA categories
Product Director doesn't appear verbatim in the TN visa occupation list. Document how your degree and responsibilities fit Management Consultant or Engineer categories before applying, so your credential package matches what CBP officers review.
Target employers with recent visa filing experience
Search for companies with recent visa filings in roles similar to yours to identify employers experienced with sponsorship logistics. These employers have demonstrated familiarity with work visa processes and may be more likely to support candidates requiring work authorization, including those pursuing TN status.
Get the support letter right before crossing
Your employer's support letter must state your job duties, degree requirements, and TN category explicitly. Canadian citizens present this at a port of entry, so ambiguous language about your role scope can result in a CBP referral or denial on the spot.
Address Mexican consular timelines early in negotiations
Mexican nationals must schedule a consular appointment in Mexico, which adds weeks to your start date. Raise this during offer negotiations so your employer builds realistic onboarding timelines and doesn't rescind for a delayed start.
Use Migrate Mate to find TN-ready Product Director roles
Search Migrate Mate to filter Product Director openings by employers who actively sponsor TN visas, so you're not cold-applying to companies that haven't navigated this process before.
Clarify TN status classification with HR before signing
Some employers classify Product Directors under broad job codes that don't map cleanly to a TN category. Confirm with HR that your offer letter specifies a recognized USMCA occupation before you sign, not after CBP reviews your documents.
Product Director TN Visa: Frequently Asked Questions
Does a Product Director role actually qualify for a TN visa?
It depends on how the role is defined. Product Director doesn't appear as a standalone TN occupation, but many Product Director positions qualify under Management Consultant or Engineer categories when the job duties and required degree align with those definitions. The employer's support letter must make that connection explicit, because CBP officers evaluate the role description and your credentials together.
How does TN visa sponsorship compare to H-1B for a Product Director position?
TN has no lottery, no annual cap for Canadians, and can be approved at the border the same day for Canadian citizens. H-1B visa requires an employer to enter a lottery in March, wait months for selection, then file a petition before an October start date. For a senior product role, TN is typically faster and less expensive for both you and your employer, though it requires a clear category fit.
What documents does my employer need to prepare for TN sponsorship?
Your employer needs a support letter on company letterhead stating your job title, a description of your duties tied to a recognized TN occupation category, your required qualifications, your compensation, and the intended duration of employment. You'll also need your own credential documents, including your degree certificate and transcripts. Canadian citizens bring these to a port of entry; Mexican nationals submit them at a U.S. consulate appointment.
Where can I find Product Director jobs with TN visa sponsorship?
Migrate Mate is built specifically for Canadian and Mexican professionals seeking U.S. roles with TN visa sponsorship. You can filter by job title and visa type to surface employers who have already sponsored TN workers, which significantly narrows your search to companies that won't require you to educate them on the process during hiring.
Can I switch employers after starting a Product Director role on TN status?
Yes, but you need a new TN authorization tied to the new employer before you start. Canadian citizens can get this at a port of entry or via a USCIS change of status filing. Mexican nationals need a new consulate appointment. You can't simply transfer your existing TN to a new company, so factor the processing timeline into any job transition plan.