Senior Principal Microbiologist

Initial Therapeutics, Inc.; Concord (NC); On-site; USD 65,250 - 169,400; Full time

Benefits offered by this job

Company bonus

401(k) and pension benefits

Medical, dental, and vision insurance

Job summary

Initial Therapeutics, Inc. in Concord, North Carolina is seeking a Sr. Principal Microbiologist. This role involves the design and installation of QC Microbiological testing systems and provides technical leadership for microbiological control strategies. Candidates should have 7-10 years of experience in a GMP Microbiology Laboratory and a Bachelor's degree in a relevant science field.

The position offers a salary range of $65,250 to $169,400 and comprehensive benefits. Applicants must be authorized to work in the United States.

Qualifications

• 7-10 years of experience in a GMP Microbiology Laboratory.
• Experience with endotoxin, bioburden, sterility testing.
• Leadership and influence in a lab setting.

Responsibilities

• Influence design of QC Microbiological testing labs.
• Lead investigations into Clean Utilities excursions.
• Conduct technical training and mentor lab analysts.

Skills

Microbiological Test Methods

Laboratory analysis

Problem-solving skills

Strong communication skills

Education

Bachelor’s degree in a science field related to microbiology or biology

Job description

Position Description

The Sr. Principal Microbiologist influences and participates in the design and installation of systems, procedures, and methods for the startup of the QC Microbiological testing and environmental monitoring labs at the site. Additionally, the Sr. Principal Microbiologist participates in the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations. This role provides technical leadership for microbiological control strategies for Purified Water (PW), Water for Injection (WFI), clean steam, compressed gases, and associated distribution systems. The Sr. Principal Microbiologist leads and supports Clean Utilities qualification, validation, technology transfer, remediation, and lifecycle management activities. The Sr. Principal Microbiologist leads the design and execution of method development, validations, technology transfers, and equipment evaluation/qualification. The Sr. Principal Microbiologist utilizes their technical skills to ensure inspection readiness, perform in-depth problem solving, proactively identify opportunities for continuous improvement, and complete thorough investigations of aberrant data and results. Outcomes of these activities, including results, conclusions, and action plans, are thoroughly and accurately documented and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff, sharing technical information and best practice within the work group and across plant sites.

Key Objectives/Deliverables

• Technical review, interpretation, and release of raw material, in-process, and finished product data.
• Serve as subject‑matter expert for Clean Utilities systems, including PW, WFI, clean steam, and critical process gases.
• Serve as subject‑matter expert for Microbiological Test Methods.
• Support qualification, validation, and lifecycle management of Clean Utilities systems.
• Contribute to annual product reviews and process validations as required.
• Perform technical training and mentor analysts through formal process/program.
• Lead and/or review change controls and complex deviations.
  • Utilize technical skills to lead or perform in-depth investigations into out‑of‑spec results and aberrant data, draw conclusions, perform root‑cause analysis, and recommend solutions to prevent recurrence.
  • Lead investigations into Clean Utilities excursions and adverse trends.
• Develop investigational testing protocols and perform testing as required.
• Author and oversee the execution of method verifications, transfers, and validations.
• Monitor method and process performance.
• Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.
• Contribute to development and implementation of Global Lab Quality Standards.
• Comply with and implement safety standards.
• Provide technical oversight for Periodic Management Reviews.
• Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.
• SME for internal and external inspections, interacting directly with inspectors and regulatory agencies.
• Types of communication include:
  • Notification to management of quality issues.
  • Interaction with other functions and auditors.
  • Participation in internal/external audits.

Minimum Requirements

• Education
  • Bachelor’s (4‑year) degree in a science field related to microbiology or biology.
• Experience
  • 7‑10 years of demonstrated relevant experience in a GMP Microbiology Laboratory, preferably associated with GMP manufacturing.
  • Leadership and influence.
  • Demonstrated proficiency in laboratory analysis including endotoxin, bioburden, sterility, bioassay, particulate matter, and organism identification.
  • Strong oral and written communication skills, demonstrated through documentation and presentation skills.

Additional Preferences

• Demonstrated strong problem‑solving skills and preferred training in Root Cause Analysis methodology.
• Demonstrated strong interpersonal interaction skills.
• Ability to focus on continuous improvement.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Deep understanding of compliance requirements and regulatory expectations.

Job Details

• Tasks may require repetitive motion and standing for long periods of time.
• 8‑hour days – Monday through Friday.
• Occasional shift work when required within the lab.
• Required to be available off shift and respond to operational issues.
• Minimal travel required.

Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position ranges from $65,250 to $169,400. Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits such as healthcare and/or dependent day‑care flexible spending accounts; life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits such as employee assistance program, fitness benefits, and employee clubs and activities. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion; Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

Equal Employment Opportunity

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

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