Alkermes · 3 hours ago
Team Leader, Quality Control (Microbiology)
Cincinnati Metro
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expAlkermes is a fully-integrated, global biopharmaceutical company committed to developing medicines for complex psychiatric and neurological disorders. The QC Team Lead will provide technical supervision in the microbiology group, coordinating projects, reviewing test results, and supporting method development and optimization for microbiological testing.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Coordinate and support Tech Services Projects, which include:
Method Validations and optimizations
New technologies and equipment
Assist in the identification of new Microbiology testing technologies and equipment to meet evolving regulatory requirements
Support regulatory audits
Write protocols and execute method verification/validation/qualification/ transfers
Write, execute laboratory investigations for out of specifications and out of trend results
Point person and Microbiology point person for higher level meetings / projects such as CMC Team support
Write documents (SOPs, specifications, technical reports)
Execute, oversee instrument qualification as necessary
Implement continuous improvement activities to maximize the resources available
Write change controls and work orders for systems and instrumentation changes
Review data as needed utilizing LIMS, SAP and SLIM
Troubleshooting of technical procedures, methodology and instrumentation
Data entry for testing results following GMP regulations
Review tests results for other analysts
Train new analysts and document training
Provide technical support to new analysts
Participate in non-routine projects, validations and method development to meet departmental and individual goals
Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations
Maintain the laboratory operations in compliance with industry regulations
The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills
Qualification
Required
A four year degree in science, preferably in Biology or Microbiology with minimum 8 years' experience in the pharmaceutical industry
Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters
Critical thinker, ability to identify issues and work quickly to resolution with minimum supervision
Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor
Understand common microbiological test instrumentation
Excellent organizational, planning and scheduling skills
Good verbal and written communication skills
Good interpersonal skills and ability to work effectively in a team environment
Commitment to continuous improvement in all areas
Ability to work safely; seek out and encourage safe practices
Experience with LIMS systems, Trackwise or similar electronic documentation system, SAP
Benefits
Health Insurance
Diversity, inclusion and belonging
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
Genetic Engineering News
2025-12-24
2025-12-19
Company data provided by crunchbase