POSITION SUMMARY
The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, act as point person on CMC Teams and validation projects. Responsibilities will also include reviewing, reporting test results as related to validation protocols. Direct Support for Method development and optimization for all Microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, Bioburden. Suggest and implement new technologies and equipment for Microbiological testing.
QUALIFICATIONS
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
MAJOR RESPONSIBILITIES
Coordinate and support Tech Services Projects, which include:
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.
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About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
