Sharp Sterile Manufacturing Visa Sponsorship Jobs USA
Sharp Sterile Manufacturing operates in the specialized world of sterile pharmaceutical and biologic contract manufacturing, where technical expertise is in high demand. The company has an established record of sponsoring work visas, making it a viable target for international candidates in the biotech and pharma space.
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Get Access To All JobsPosition Summary
The Senior Formulation Scientist is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Formulation Chemist is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.
Duties and Responsibilities
- Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
- Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
- Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
- Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
- Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
- Identify and order materials required to perform development and manufacturing
- Identify tooling and equipment required to perform development and manufacturing
- Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
- Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
- Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
- Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
- Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
- Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
- Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
- Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
- Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
- Carry out all job responsibilities in a safe manner
- Develop equipment and processes that meet safety codes, policies and guidelines
- Provide for the safety and well-being of operators, maintenance, and other personnel
- Confer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests
- Other duties as assigned
Regulatory Responsibilities
- Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
- Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
Supervisory Responsibilities
- Lead/support validation activities including equipment validation and process validation
- Lead problem solving and investigate quality events related to formulation process or batch records
- Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
- Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
- Supervise, mentor and develop team members or relevant personnel across departments
Experience
A minimum of three (3) years of experience in pharmaceutical research and manufacturing
Education
Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
Knowledge, Skills & Abilities
- Experience in sterile manufacturing is preferred
- Experience in lyophilization and terminal sterilization techniques are a plus
- Knowledge of parenteral drug product manufacturing
- Proficient with calculation, data analysis, statistics and applied mathematics
- Exceptional computer skills including Microsoft Office, Visio or other related software
- Excellent writing skills
- Attention to detail
Physical Requirements
- Ability to sit for prolonged periods of time
- Ability to stand for prolonged periods of time
- Able to lift up to 50lbs
Position Summary
The Senior Formulation Scientist is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Formulation Chemist is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.
Duties and Responsibilities
- Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
- Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
- Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
- Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
- Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
- Identify and order materials required to perform development and manufacturing
- Identify tooling and equipment required to perform development and manufacturing
- Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
- Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
- Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
- Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
- Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
- Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
- Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
- Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
- Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
- Carry out all job responsibilities in a safe manner
- Develop equipment and processes that meet safety codes, policies and guidelines
- Provide for the safety and well-being of operators, maintenance, and other personnel
- Confer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests
- Other duties as assigned
Regulatory Responsibilities
- Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
- Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
Supervisory Responsibilities
- Lead/support validation activities including equipment validation and process validation
- Lead problem solving and investigate quality events related to formulation process or batch records
- Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
- Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
- Supervise, mentor and develop team members or relevant personnel across departments
Experience
A minimum of three (3) years of experience in pharmaceutical research and manufacturing
Education
Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
Knowledge, Skills & Abilities
- Experience in sterile manufacturing is preferred
- Experience in lyophilization and terminal sterilization techniques are a plus
- Knowledge of parenteral drug product manufacturing
- Proficient with calculation, data analysis, statistics and applied mathematics
- Exceptional computer skills including Microsoft Office, Visio or other related software
- Excellent writing skills
- Attention to detail
Physical Requirements
- Ability to sit for prolonged periods of time
- Ability to stand for prolonged periods of time
- Able to lift up to 50lbs
Job Roles at Sharp Sterile Manufacturing
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Get Access To All JobsTips for Finding Sharp Sterile Manufacturing Visa Sponsorship Jobs USA
Target roles that align with sterile manufacturing expertise
Sharp Sterile Manufacturing's sponsorship activity centers on technical and scientific roles in pharmaceutical manufacturing. Focus your applications on positions in process engineering, quality assurance, regulatory affairs, and analytical chemistry, where international talent is most in demand.
Understand which visa types Sharp supports
Sharp Sterile Manufacturing sponsors H-1B, F-1 OPT, and F-1 CPT visas, along with TN visas for Canadian and Mexican nationals. Knowing this upfront lets you approach the application process with realistic expectations and target the right pathway for your situation.
Use your OPT or CPT window strategically
If you're on F-1 status, Sharp's support for OPT and CPT makes it a practical entry point into U.S. pharma manufacturing. Landing a role during your OPT period positions you well for an H-1B sponsorship conversation before your work authorization expires.
Highlight GMP and regulatory compliance experience
In sterile contract manufacturing, Good Manufacturing Practice credentials carry significant weight. Candidates who demonstrate hands-on GMP experience or familiarity with FDA regulatory requirements are far more likely to clear internal hiring bars that support the sponsorship process.
Apply well ahead of the H-1B registration window
H-1B registration opens in early March each year. To be considered, you need to have an offer in place before then. Start targeting Sharp Sterile Manufacturing roles in the fall or early winter to give yourself enough runway before the deadline.
Filter for verified sponsors before you apply
Not every pharma company that looks promising actually sponsors visas. Migrate Mate surfaces verified sponsors so you can filter by real sponsorship history, saving time and ensuring Sharp Sterile Manufacturing roles you find are confirmed for international applicants.
Frequently Asked Questions
Does Sharp Sterile Manufacturing sponsor H-1B visas?
Yes, Sharp Sterile Manufacturing sponsors H-1B visas. The company has a track record of supporting H-1B petitions for roles in its sterile pharmaceutical manufacturing operations, particularly in technical and scientific functions. If you're targeting Sharp for H-1B sponsorship, aim to secure an offer before early March, when the annual H-1B registration window opens with USCIS.
What visa types does Sharp Sterile Manufacturing sponsor?
Sharp Sterile Manufacturing sponsors H-1B visas for specialty occupation roles, F-1 OPT and F-1 CPT for students and recent graduates, and TN visas for eligible Canadian and Mexican nationals working in qualifying professional categories. The company does not have a recorded history of sponsoring Green Cards or E-3 visas, so international candidates should plan accordingly.
Which departments or roles at Sharp Sterile Manufacturing are most likely to receive visa sponsorship?
Sponsorship at Sharp Sterile Manufacturing tends to align with the technical core of its business: sterile drug manufacturing, quality control, process engineering, regulatory affairs, and analytical sciences. Roles requiring specialized pharmaceutical or biotechnology credentials are the strongest candidates for sponsorship, as these positions are harder to fill without drawing from an international talent pool.
What is the typical application and sponsorship timeline at Sharp Sterile Manufacturing?
The timeline depends on your visa type. For F-1 OPT and CPT, authorization can begin relatively quickly after an offer. For H-1B sponsorship, the process is tied to USCIS's annual cap cycle: registration opens in March, and approved petitions take effect October 1. That means you need an offer in place months before the registration window, making fall and early winter the ideal time to start applying.
How do I find open visa-sponsored jobs at Sharp Sterile Manufacturing?
The most reliable approach is to search on Migrate Mate, which tracks verified sponsorship histories so you can confirm a company's track record before applying. Sharp Sterile Manufacturing's profile on Migrate Mate shows the visa types it sponsors and surfaces current openings, helping you focus your effort on roles where international candidates are genuinely considered rather than sorting through job listings with no sponsorship clarity.