H-1B Visa Principal Scientist Jobs
Principal Scientist roles qualify as H-1B 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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JOB DESCRIPTION
The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.
Our team is looking for a candidate for the position of Associate Principal Scientist supporting the Biologics team within Sterile Product Development.
Primary duties:
- Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis
- Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
- Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.
- Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.
- Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.
- Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.
- Leads project activities at external manufacturing sites including tech transfers
- Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
- Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others
Education Minimum Requirement:
- Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.
Required Experience and Skills:
- Experienced in biologics process development and characterization particularly for late stage programs
- Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process
- Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas
- Has broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development process
- Track record of working effectively with team-members of skill sets and backgrounds
- Strong verbal and written communication skills
- The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent.
Preferred Experience and Skills:
- Deep understanding of one or more of the following: surface science, colloid science, particle engineering and/or high concentration formulations
- Prior experience leading development projects at an enterprise level
- Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor
- Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology
- Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.
- Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
- Prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred.
Required Skills:
Biologics, Cross-Functional Leadership, Downstream Process Development, Drug Delivery Technology, Drug Development, Drug Formulations, Formulation Chemistry, Formulation Development, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Sciences, Physical Characterization, Regulatory Filings, Stakeholder Engagement, Sterile Manufacturing, Sterile Products, Strategic Planning
Preferred Skills:
Colloid Science, Particle Engineering, Surface Science
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:
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
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is $142,400.00 - $224,100.00
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: 25%
Flexible Work Arrangements: Not Applicable
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Job Posting End Date: 05/27/2026
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.
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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.
Principal Scientist jobs are hiring across the US. Find yours.
Find Principal Scientist JobsPrincipal Scientist H-1B Visa: 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.
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