Kyowa Kirin, Inc.- U.S.
Specialist II, Quality Control - Microbiology
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
Specialist II, Quality Control - Microbiology
Sanford, NC
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
The Specialist II, Quality Control Microbiology plays a key role in establishing and executing microbiological testing activities within the QC organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.
Responsibilities
Perform routine and moderately complex microbiological tasks to enable QC operations and contribute to business processes. Collaborate cross-functionally during early-stage site activities, including identifying user requirements and prioritizing implementation of equipment, instruments, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).
Execute and assist in the qualification and transfer of compendial and non-routine microbiological methods in accordance with GxP standards, SOPs, and specifications. Techniques include bioburden (TAMC/TYMC), bacterial endotoxins (LAL), growth promotion, microbial identification, and rapid microbiological methods.
Apply working knowledge of sampling, culturing, microscopy, and aseptic techniques across a variety of sample types (e.g., water, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations).
Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS) to enable operational readiness of the Microbiology Laboratory.
Participate in Site Risk Management activities, documenting risk-based decisions using compliant methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.
Implement GxP procedures related to the Environmental and Utility Monitoring Program and Contamination Control Strategy in coordination with cross-functional teams.
Train and qualify team members in microbiological methods and contamination control practices. Assist in onboarding junior staff and contractors per approved staffing plans.
Assist with utilities qualification and environmental monitoring performance qualification (EMPQ) to ensure facility readiness and alignment with production goals.
Review validation and qualification documentation for facility systems, microbiological instruments, and computerized systems to confirm commissioning and operational readiness.
Coordinate and perform sampling and testing activities. Review QC laboratory results for accuracy and completeness under moderate supervision.
Maintain core lab operations, including gowning protocols, personnel and material flow, sample handling, inventory management, lab safety, waste disposal, and cleaning procedures.
Prepare and contribute to laboratory reports, including microbial trend reports, EM/UM recoveries, excursion reports, OOS, and invalid assay documentation.
Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Microbiology activities with global and regional policies and inspection readiness expectations.
Participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting and implementing corrective and preventive actions (CAPAs).
Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, EM data trends, stability trends, and product disposition cycle times.
Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Microbiology function aligned with Kyowa Kirin’s manufacturing and quality strategy.
Track progress against individual and team goals, and communicate updates to the Site Leadership Team and key stakeholders.
Qualifications
Education
Bachelor’s degree in Microbiology, Biotechnology, or a related Life Sciences discipline required.
Master’s degree or graduate-level studies preferred.
Experience
Minimum of 2 to 4 years of experience in a Quality Control Microbiology laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations.
Experience investigating microbial contamination incidents, laboratory non-conformances (e.g., OOS), and interpreting data within the framework of Quality Management Systems (QMS), laboratory controls, and applicable regulatory standards.
Experience contributing to the start-up of a QC Microbiology laboratory in a new facility is a plus.
Familiarity with engineering and GxP documentation related to equipment, facilities, and process qualification efforts (e.g., validation protocols, reports, test plans, verification plans, validation master plans, site master file) is also preferred.
Technical Skills
Proficient in MS Office Suite, and Lean Labs or Agile Lean.
Skilled in bioburden, bacterial endotoxins, growth promotion, microbial identification, and rapid microbiological methods.
Experience with LIMS, ELN, and LES systems.
Solid knowledge of GxP standards, SOPs, and quality systems.
Non‑Technical Skills
Results‑oriented, able to navigate ambiguity, and proactively drive measurable outcomes.
Strong interpersonal and communication skills; inclusive and collaborative mindset.
Adaptable, resilient, and able to thrive in fast‑paced, evolving environments.
Organized, detail‑focused, and capable of managing multiple tasks and priorities.
Benefits
401K with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut‑Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
Well‑Being and Work/Life Programs
Long‑Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Pet Insurance
Tuition Assistance
Employee Referral Awards
The anticipated salary for this position will be $81,000 to $105,800.
Requires up to 10% domestic and limited international travel.
This position is based on‑site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
The Specialist II, Quality Control Microbiology plays a key role in establishing and executing microbiological testing activities within the QC organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.
Responsibilities
Perform routine and moderately complex microbiological tasks to enable QC operations and contribute to business processes. Collaborate cross-functionally during early-stage site activities, including identifying user requirements and prioritizing implementation of equipment, instruments, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).
Execute and assist in the qualification and transfer of compendial and non-routine microbiological methods in accordance with GxP standards, SOPs, and specifications. Techniques include bioburden (TAMC/TYMC), bacterial endotoxins (LAL), growth promotion, microbial identification, and rapid microbiological methods.
Apply working knowledge of sampling, culturing, microscopy, and aseptic techniques across a variety of sample types (e.g., water, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations).
Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS) to enable operational readiness of the Microbiology Laboratory.
Participate in Site Risk Management activities, documenting risk-based decisions using compliant methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.
Implement GxP procedures related to the Environmental and Utility Monitoring Program and Contamination Control Strategy in coordination with cross-functional teams.
Train and qualify team members in microbiological methods and contamination control practices. Assist in onboarding junior staff and contractors per approved staffing plans.
Assist with utilities qualification and environmental monitoring performance qualification (EMPQ) to ensure facility readiness and alignment with production goals.
Review validation and qualification documentation for facility systems, microbiological instruments, and computerized systems to confirm commissioning and operational readiness.
Coordinate and perform sampling and testing activities. Review QC laboratory results for accuracy and completeness under moderate supervision.
Maintain core lab operations, including gowning protocols, personnel and material flow, sample handling, inventory management, lab safety, waste disposal, and cleaning procedures.
Prepare and contribute to laboratory reports, including microbial trend reports, EM/UM recoveries, excursion reports, OOS, and invalid assay documentation.
Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Microbiology activities with global and regional policies and inspection readiness expectations.
Participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting and implementing corrective and preventive actions (CAPAs).
Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, EM data trends, stability trends, and product disposition cycle times.
Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Microbiology function aligned with Kyowa Kirin’s manufacturing and quality strategy.
Track progress against individual and team goals, and communicate updates to the Site Leadership Team and key stakeholders.
Qualifications
Education
Bachelor’s degree in Microbiology, Biotechnology, or a related Life Sciences discipline required.
Master’s degree or graduate-level studies preferred.
Experience
Minimum of 2 to 4 years of experience in a Quality Control Microbiology laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations.
Experience investigating microbial contamination incidents, laboratory non-conformances (e.g., OOS), and interpreting data within the framework of Quality Management Systems (QMS), laboratory controls, and applicable regulatory standards.
Experience contributing to the start-up of a QC Microbiology laboratory in a new facility is a plus.
Familiarity with engineering and GxP documentation related to equipment, facilities, and process qualification efforts (e.g., validation protocols, reports, test plans, verification plans, validation master plans, site master file) is also preferred.
Technical Skills
Proficient in MS Office Suite, and Lean Labs or Agile Lean.
Skilled in bioburden, bacterial endotoxins, growth promotion, microbial identification, and rapid microbiological methods.
Experience with LIMS, ELN, and LES systems.
Solid knowledge of GxP standards, SOPs, and quality systems.
Non‑Technical Skills
Results‑oriented, able to navigate ambiguity, and proactively drive measurable outcomes.
Strong interpersonal and communication skills; inclusive and collaborative mindset.
Adaptable, resilient, and able to thrive in fast‑paced, evolving environments.
Organized, detail‑focused, and capable of managing multiple tasks and priorities.
Benefits
401K with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut‑Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
Well‑Being and Work/Life Programs
Long‑Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Pet Insurance
Tuition Assistance
Employee Referral Awards
The anticipated salary for this position will be $81,000 to $105,800.
Requires up to 10% domestic and limited international travel.
This position is based on‑site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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