H-1B Visa Formulation Scientist Jobs
Formulation Scientist roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in chemistry, chemical engineering, pharmaceutical sciences, or a directly related field. Employers file a Labor Condition Application with DOL and an I-129 petition with USCIS to sponsor your status for up to three years, extendable to six.
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Biogen is seeking a Principal Scientist, Oral Formulation Development to provide scientific leadership for the development of small molecule oral drug products. This role leads formulation and process development across clinical programs, with a focus on enabling technologies for challenging compounds, clinical manufacturing readiness, and technology transfer. The role requires the ability to manage multiple interfaces with manufacturing, quality, regulatory CMC, and other technical functions. This role will also be responsible for managing external partnerships and advancing new technologies and workflows that strengthen Biogen’s oral drug product development capabilities.
What You’ll Do
- Lead formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage forms across all stages of development.
- Develop enabling formulation approaches for challenging compounds, including poorly soluble, poorly permeable, unstable, or complex molecules.
- Serve as the drug product representative on cross-functional CMC and asset teams, driving alignment across regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.
- Influence portfolio decisions through assessment of developability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.
- Champion technology transfer, clinical manufacturing readiness, and scale-up activities at internal and external manufacturing sites.
- Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.
Oversee completion of drug product sections for regulatory submissions and related technical documentation.
Required Skills
- PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline with a minimum of 10 years’ experience in oral drug product development.
- Demonstrated track record leading formulation and process development for oral solid dosage forms from early development through clinical manufacturing.
- Strong understanding and hands-on experience with oral solid dose manufacturing unit operations and manufacturability considerations.
- Experience with scale-up, technology transfer, clinical manufacturing, and external manufacturing organizations.
- Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase-appropriate development strategies.
Preferred Skills
- Deep expertise in enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.
- Experience implementing new technologies, digital tools, knowledge platforms, or best practices across multiple programs.
- Demonstrated success managing external CDMO/CMO relationships and technology transfer activities.
- Experience with late-stage development, commercial readiness, process characterization, and process validation.
Job Level: Management
Additional Information
The base compensation range for this role is: $159,000.00-$219,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit, and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
About the Role
Biogen is seeking a Principal Scientist, Oral Formulation Development to provide scientific leadership for the development of small molecule oral drug products. This role leads formulation and process development across clinical programs, with a focus on enabling technologies for challenging compounds, clinical manufacturing readiness, and technology transfer. The role requires the ability to manage multiple interfaces with manufacturing, quality, regulatory CMC, and other technical functions. This role will also be responsible for managing external partnerships and advancing new technologies and workflows that strengthen Biogen’s oral drug product development capabilities.
What You’ll Do
- Lead formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage forms across all stages of development.
- Develop enabling formulation approaches for challenging compounds, including poorly soluble, poorly permeable, unstable, or complex molecules.
- Serve as the drug product representative on cross-functional CMC and asset teams, driving alignment across regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.
- Influence portfolio decisions through assessment of developability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.
- Champion technology transfer, clinical manufacturing readiness, and scale-up activities at internal and external manufacturing sites.
- Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.
Oversee completion of drug product sections for regulatory submissions and related technical documentation.
Required Skills
- PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline with a minimum of 10 years’ experience in oral drug product development.
- Demonstrated track record leading formulation and process development for oral solid dosage forms from early development through clinical manufacturing.
- Strong understanding and hands-on experience with oral solid dose manufacturing unit operations and manufacturability considerations.
- Experience with scale-up, technology transfer, clinical manufacturing, and external manufacturing organizations.
- Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase-appropriate development strategies.
Preferred Skills
- Deep expertise in enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.
- Experience implementing new technologies, digital tools, knowledge platforms, or best practices across multiple programs.
- Demonstrated success managing external CDMO/CMO relationships and technology transfer activities.
- Experience with late-stage development, commercial readiness, process characterization, and process validation.
Job Level: Management
Additional Information
The base compensation range for this role is: $159,000.00-$219,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit, and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Formulation Scientist
Align your degree to the role
Your H-1B petition is stronger when your degree field directly maps to formulation work. A chemistry, pharmaceutical sciences, or chemical engineering degree paired with a job description citing those disciplines reduces RFE risk on the specialty occupation requirement.
Look up prevailing wages before negotiating
Use the OFLC Wage Search to find the certified wage level for Formulation Scientist positions in your target metro before you negotiate an offer. Your employer's LCA must certify a wage at or above that level, so knowing it protects you.
Target employers with active LCA filing history
Search Migrate Mate to find employers with verified H-1B LCA filing history for formulation and R&D roles. Pharma, biotech, and consumer goods manufacturers file regularly, making them more predictable sponsors than companies filing for the first time.
Confirm each worksite before your LCA is filed
If your role involves work at a contract manufacturing site, a client facility, or a second lab location, alert your employer early. DOL requires a separate certified LCA for each worksite, and adding locations after filing creates compliance gaps.
Review the O*NET profile before your interview
O*NET lists the core tasks and knowledge domains for formulation scientist roles. Preparing examples that map your experience to those specific duties helps you and your employer build a coherent specialty occupation case for USCIS.
Track cap selection rule changes before each cycle
H-1B cap selection rules have changed recently. Check USCIS directly each year for current registration requirements and timelines so your employer files your petition with accurate, up-to-date procedures.
H-1B Visa Formulation Scientist: Frequently Asked Questions
Does a Formulation Scientist role qualify as an H-1B specialty occupation?
Yes. Formulation Scientist positions typically require at least a bachelor's degree in chemistry, pharmaceutical sciences, chemical engineering, or a closely related discipline. Because the role demands theoretical and applied knowledge specific to those fields, it meets the USCIS specialty occupation standard. Your employer documents this in the I-129 petition by describing the degree requirement and how it ties to the actual job duties.
Which industries sponsor H-1B visas most often for Formulation Scientists?
Pharmaceutical manufacturers, biotechnology companies, medical device firms, cosmetics and personal care product developers, and specialty chemical companies are the most active sponsors. These employers run ongoing R&D programs that require formulation expertise and file LCAs regularly through DOL. You can browse employers with verified H-1B LCA filing history for these industries on Migrate Mate.
What documents should I prepare before my employer files the H-1B petition?
Gather your academic transcripts and degree certificates, any credential evaluations if your degree is from outside the U.S., and documentation of specialized training or certifications in formulation techniques. Your employer will need these to build the specialty occupation argument in the I-129 and to satisfy USCIS that your background directly supports the role.
Can my employer transfer my H-1B if I move to a different lab or formulation site?
A change of worksite requires a new certified LCA filed with DOL before you begin working at the new location. This applies even within the same employer if the new site is in a different metropolitan statistical area. Short-term placements at client or contract manufacturing sites also require their own LCA, so flag any worksite changes to your employer early in the planning process.
How long does H-1B status last for a Formulation Scientist position?
H-1B status is initially granted for up to three years and can be extended for an additional three years, reaching a six-year maximum under standard rules. Extensions beyond six years are possible if your employer has an active green card process that has reached a certain stage. USCIS sets those extension rules, so your employer's immigration counsel should track your timeline against your priority date.