H-1B Visa Principal Scientist Jobs
Principal Scientist roles qualify as H-1B visa specialty occupations under the research and life sciences SOC codes, requiring at least a bachelor's degree in a directly related field. Large pharmaceutical, biotech, and tech R&D employers regularly file H-1B petitions for this title, and many are cap-exempt through university or nonprofit research affiliations.
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Principal Scientist, Biologics, Sterile Drug Product Commercialization
As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for biologics.
It is the division’s leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of biologics and combination products.
We are seeking an experienced Principal Scientist to advance and commercialize biologics pipeline programs. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.
Accountabilities and Responsibilities for this position include but are not limited to the following:
- Execute and provides oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation
- Leads and/or serves on cross functional biologics drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
- Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
- Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
- Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
- Develops a process and product development plan. Influences decisions related to primary packaging and combination product design.
- Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
- Ensures fit-for-purpose scale-down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
- Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in-process controls. Drives and influences process demonstration and qualification (PPQ) and shelf-life strategies.
- Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions.
- Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
- Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Travel:
This position may require travel up to 25%; Must be able to travel for this position.
Position Qualifications:
Education Minimum Requirements
- B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
- Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
- Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience
Required Experience and Skills:
- Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs and/or fusion proteins)
- Experience with at scale biologics drug product manufacturing and fill finish operations
- Experience with late-stage commercialization of biologics programs
- Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
- Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment
Preferred Experience and Skills
- Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial
- Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
- Experience with commercialization of biologics programs through PPQ and launch
- Working knowledge in analytical methods and product attributes for biologics
- Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
- Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
- Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
- Experience in Data Analytics, Computer Modeling, and Digital Applications.
- Working understanding of analytical methods to characterize biologics and other sterile drug products
Required Skills:
Accountability, Biochemistry, Biologics, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Manufacturing, Cross-Functional Teamwork, Decision Making, Design Management, Driving Continuous Improvement, Drug Product Development, Drug Product Manufacturing, Good Manufacturing Practices (GMP), Manufacturing Processes, Manufacturing Scale-Up, Mentorship, Multivariate Data Analysis, New Product Introduction Process, Planning, Process Characterization, Process Control, Process Design, Process Optimization
Preferred Skills:
Biological Manufacturing
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
COMPENSATION
- Salary Range: $173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/30/2026
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R389384
INTRODUCTION
Principal Scientist, Biologics, Sterile Drug Product Commercialization
As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for biologics.
It is the division’s leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of biologics and combination products.
We are seeking an experienced Principal Scientist to advance and commercialize biologics pipeline programs. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.
Accountabilities and Responsibilities for this position include but are not limited to the following:
- Execute and provides oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation
- Leads and/or serves on cross functional biologics drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
- Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
- Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
- Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
- Develops a process and product development plan. Influences decisions related to primary packaging and combination product design.
- Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
- Ensures fit-for-purpose scale-down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
- Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in-process controls. Drives and influences process demonstration and qualification (PPQ) and shelf-life strategies.
- Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions.
- Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
- Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Travel:
This position may require travel up to 25%; Must be able to travel for this position.
Position Qualifications:
Education Minimum Requirements
- B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
- Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
- Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience
Required Experience and Skills:
- Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs and/or fusion proteins)
- Experience with at scale biologics drug product manufacturing and fill finish operations
- Experience with late-stage commercialization of biologics programs
- Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
- Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment
Preferred Experience and Skills
- Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial
- Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
- Experience with commercialization of biologics programs through PPQ and launch
- Working knowledge in analytical methods and product attributes for biologics
- Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
- Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
- Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
- Experience in Data Analytics, Computer Modeling, and Digital Applications.
- Working understanding of analytical methods to characterize biologics and other sterile drug products
Required Skills:
Accountability, Biochemistry, Biologics, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Manufacturing, Cross-Functional Teamwork, Decision Making, Design Management, Driving Continuous Improvement, Drug Product Development, Drug Product Manufacturing, Good Manufacturing Practices (GMP), Manufacturing Processes, Manufacturing Scale-Up, Mentorship, Multivariate Data Analysis, New Product Introduction Process, Planning, Process Characterization, Process Control, Process Design, Process Optimization
Preferred Skills:
Biological Manufacturing
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
COMPENSATION
- Salary Range: $173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/30/2026
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R389384
See all 341+ H-1B Visa Principal Scientist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Principal Scientist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Principal Scientist
Verify your SOC code before applying
Principal Scientist maps to multiple SOC codes depending on your discipline. Check O*NET to confirm the right code for your specialty, since mismatches between your degree field and the SOC code on the LCA are a common source of H-1B RFEs.
Target cap-exempt employers directly
Universities, nonprofit research institutions, and government research labs can file H-1B petitions outside the annual cap and lottery. Prioritizing these employers means your petition can be filed any time of year, not just in April.
Use Migrate Mate to filter by LCA filing history
Search Principal Scientist roles on Migrate Mate to see which employers have active DOL Labor Condition Application filings for this title. That filing history confirms the employer has sponsored this role before, not just that they're open to it in principle.
Request the prevailing wage determination early
Ask your prospective employer to run the OFLC Wage Search for your specific SOC code and worksite location before your offer letter is finalized. The offered salary must meet or exceed the prevailing wage level, and misalignments discovered late can delay filing significantly.
Document your research contributions for the specialty occupation argument
USCIS scrutinizes Principal Scientist petitions where the role blends research and management duties. Gather publications, patent filings, and project records that show your duties require a specific advanced degree, not just general scientific knowledge.
Negotiate H-1B filing timelines into your offer
Cap-subject H-1B petitions have an October 1 start date, meaning an April lottery win translates to a five-month gap. During offer negotiations, clarify whether the employer will cover premium processing and how they handle your authorization during the gap period.
H-1B Visa Principal Scientist: Frequently Asked Questions
Does a Principal Scientist role qualify as an H-1B specialty occupation?
Yes. Principal Scientist positions qualify as H-1B specialty occupations because the role requires at least a bachelor's degree in a directly related scientific field, such as biochemistry, molecular biology, chemistry, or data science. USCIS looks at whether the specific duties require that degree, not just whether the employer prefers it. Roles that blend scientific research with broad management duties face more scrutiny, so the job description should clearly tie each core duty to a specialized degree requirement.
Which employers most commonly sponsor H-1B visas for Principal Scientists?
Pharmaceutical companies, biotechnology firms, medical device manufacturers, and large technology companies with in-house R&D divisions are the most active H-1B sponsors for Principal Scientist roles. Universities and nonprofit research institutes also sponsor this title and have the added advantage of being cap-exempt, meaning they aren't subject to the annual H-1B lottery. You can browse employers with verified LCA filing history for this role on Migrate Mate.
How does the H-1B cap lottery affect Principal Scientist job seekers?
If you're targeting a for-profit employer that isn't affiliated with a university or qualifying nonprofit, your H-1B petition enters the annual lottery capped at 85,000 slots. Registration opens in March, and selections are announced before April 1 for an October 1 start date. Not being selected doesn't disqualify you permanently, but it means waiting to register again the following year unless you identify a cap-exempt employer in the interim.
Can my employer file an H-1B petition if my degree is from outside the United States?
Yes, but your employer will typically need a credential evaluation confirming your foreign degree is equivalent to a U.S. bachelor's degree or higher in the relevant field. For Principal Scientist roles, USCIS also accepts a combination of a lower degree plus progressive work experience under the three-for-one equivalency rule, where three years of specialized experience substitutes for one year of formal education. The evaluation must come from a recognized credential evaluation service.
What happens to my H-1B status if I change employers as a Principal Scientist?
H-1B portability under AC21 lets you start working for a new employer as soon as your new employer files a transfer petition, provided your current H-1B has been approved for at least 180 days. Your new employer files a fresh I-129 petition with a new LCA certified for the new worksite and salary. You don't re-enter the lottery for a transfer, but the new petition must independently satisfy all specialty occupation requirements for the Principal Scientist role as defined by the new employer.