Biotech & Pharma H-1B Sponsorship Jobs in Kentucky
H-1B visa sponsorship biotech and pharma jobs in Kentucky are concentrated around Louisville, where companies like Humana, Kindred Biosciences, and a growing cluster of life sciences firms operate. The state's expanding research corridor, anchored by the University of Louisville and regional CROs, creates demand for sponsored roles in clinical research, regulatory affairs, and pharmaceutical sciences.
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Get Access To All JobsINTRODUCTION
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
ROLE AND RESPONSIBILITIES
Job Title: Sr. Manager Quality Control
Business: Pharma Solutions
Department: Analytical Quality Control (AQC)
Location: Lexington
Reporting to the Director of Quality, the Sr. Manager, Quality Control has responsibility for the Analytical and Microbiology Quality Control (AQC/MQC) laboratories. The position will provide strategic direction and leadership to improve quality, efficiency, process standardization, and capabilities of the Quality Control Department.
Key Responsibilities:
- Direct oversight of activities performed within Quality Control Laboratories
- Monitor revenue goals ensuring that Laboratories meet or exceed expectations
- Develop and manage department budgets
- Regularly monitor applicable internet and written information published by US FDA, EMA, PMDA, Other Applicable Agencies as required, and pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
- Establish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
- Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed
- Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibration
- Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirements
- Oversee all quality investigations within the departments (deviations, CAPA and LIR)
- Ensure Lab is a constant state of compliance and Sustains Permanent Inspection Readiness (PIR)
- Ensure suitable laboratory safety procedures are in place
- Ensure that there is a department training program in place so that department staff are continuously developing and are current with industry practice
- Ensure that department technical expertise and capabilities are constantly evolving and current with industry
- Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
- Analyse and trend sample results and perform statistical studies and evaluations of key performance indicators
- Develop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs
- Serve as liaison with the corporate data, documentation, and review center
- Interact directly with project managers, clients, consultants, and regulatory agencies
- Oversee the development, execution and implementation of quality improvement plans within the QC Department
- Oversee the identification, procurement, qualification and implementation of new laboratory equipment, and software platforms (i.e. LIMS, Empower, etc.) as needed
- Perform gap assessments and implement CAPAs as needed
- Support internal and external audits, agency inspections, responses and CAPAs
- Support Cross Functional Quality and Operational activities/projects as needed
- Create and support an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
- Lead and develop/mentor QC members
- Assign department resources so that company goals/timelines are achieved
BASIC QUALIFICATIONS
- B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferred
- Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
- Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
- Strong/demonstrated knowledge of cGMP regulations
- Possess excellent technical writing and oral communication skills
- Six Sigma Green Belt, Benchmarking and Project Management experience preferred
- Ability to travel as needed
PREFERRED QUALIFICATIONS
- Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
- Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
- Strong/demonstrated knowledge of cGMP regulations
- Possess excellent technical writing and oral communication skills
INTRODUCTION
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
ROLE AND RESPONSIBILITIES
Job Title: Sr. Manager Quality Control
Business: Pharma Solutions
Department: Analytical Quality Control (AQC)
Location: Lexington
Reporting to the Director of Quality, the Sr. Manager, Quality Control has responsibility for the Analytical and Microbiology Quality Control (AQC/MQC) laboratories. The position will provide strategic direction and leadership to improve quality, efficiency, process standardization, and capabilities of the Quality Control Department.
Key Responsibilities:
- Direct oversight of activities performed within Quality Control Laboratories
- Monitor revenue goals ensuring that Laboratories meet or exceed expectations
- Develop and manage department budgets
- Regularly monitor applicable internet and written information published by US FDA, EMA, PMDA, Other Applicable Agencies as required, and pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
- Establish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
- Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed
- Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibration
- Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirements
- Oversee all quality investigations within the departments (deviations, CAPA and LIR)
- Ensure Lab is a constant state of compliance and Sustains Permanent Inspection Readiness (PIR)
- Ensure suitable laboratory safety procedures are in place
- Ensure that there is a department training program in place so that department staff are continuously developing and are current with industry practice
- Ensure that department technical expertise and capabilities are constantly evolving and current with industry
- Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
- Analyse and trend sample results and perform statistical studies and evaluations of key performance indicators
- Develop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs
- Serve as liaison with the corporate data, documentation, and review center
- Interact directly with project managers, clients, consultants, and regulatory agencies
- Oversee the development, execution and implementation of quality improvement plans within the QC Department
- Oversee the identification, procurement, qualification and implementation of new laboratory equipment, and software platforms (i.e. LIMS, Empower, etc.) as needed
- Perform gap assessments and implement CAPAs as needed
- Support internal and external audits, agency inspections, responses and CAPAs
- Support Cross Functional Quality and Operational activities/projects as needed
- Create and support an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
- Lead and develop/mentor QC members
- Assign department resources so that company goals/timelines are achieved
BASIC QUALIFICATIONS
- B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferred
- Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
- Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
- Strong/demonstrated knowledge of cGMP regulations
- Possess excellent technical writing and oral communication skills
- Six Sigma Green Belt, Benchmarking and Project Management experience preferred
- Ability to travel as needed
PREFERRED QUALIFICATIONS
- Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
- Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
- Strong/demonstrated knowledge of cGMP regulations
- Possess excellent technical writing and oral communication skills
H-1B Biotech & Pharma Job Roles in Kentucky
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Search Biotech & Pharma Jobs in KentuckyBiotech & Pharma H-1B Sponsorship Jobs in Kentucky: Frequently Asked Questions
Which biotech and pharma companies sponsor H-1B visas in Kentucky?
Louisville-based employers are the primary source of biotech and pharma H-1B visa sponsorships in Kentucky. Companies with documented LCA filings in the state include pharmaceutical manufacturers, contract research organizations (CROs), and specialty drug firms operating in the Louisville metro. Hospital systems with research divisions, such as Norton Healthcare and Baptist Health, also periodically sponsor H-1B workers in clinical and scientific roles.
Which cities in Kentucky have the most biotech and pharma H-1B sponsorship jobs?
Louisville accounts for the large majority of biotech and pharma H-1B sponsorship activity in Kentucky, driven by its concentration of life sciences employers, research hospitals, and pharmaceutical distribution infrastructure. Lexington is a secondary market, with University of Kentucky's medical and research programs supporting some sponsorship activity. Outside these two cities, H-1B biotech opportunities in Kentucky are limited.
What types of biotech and pharma roles typically qualify for H-1B sponsorship in Kentucky?
Roles that typically qualify require at least a bachelor's degree in a specific technical field directly related to the position. In Kentucky's biotech and pharma sector, this commonly includes clinical research associates, regulatory affairs specialists, pharmaceutical scientists, biostatisticians, quality assurance managers, and research scientists in chemistry or biology. General lab technician or manufacturing roles that don't require a specific degree field are less likely to qualify as H-1B specialty occupations.
How do I find biotech and pharma H-1B sponsorship jobs in Kentucky?
Migrate Mate is built specifically for international job seekers and filters biotech and pharma listings in Kentucky by H-1B sponsorship availability, saving you from sorting through employers who won't sponsor. You can search by role type and location to identify which Louisville and Lexington employers are actively hiring sponsored positions. Checking DOL LCA disclosure data alongside Migrate Mate listings gives you a clearer picture of which companies have recent H-1B filing history in the state.
Are there any Kentucky-specific or industry-specific considerations for H-1B sponsorship in biotech and pharma?
Kentucky doesn't have a state-level visa program, so all H-1B sponsorship follows federal USCIS and DOL requirements. One industry-specific consideration is that pharma and biotech roles in Kentucky often involve DEA-regulated substances or FDA-regulated manufacturing, which can add background check and compliance steps during onboarding without affecting the H-1B petition itself. Kentucky's life sciences sector is smaller than coastal hubs, so the pool of actively sponsoring employers is narrower and competition for sponsored roles can be higher.
What is the prevailing wage for H-1B biotech & pharma jobs in Kentucky?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.