Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
QC Analyst I/II - Micro
QCAnalyst I/lI must have broad knowledge of all the techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing, data entry and occasional review of data for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment
Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product
If required, must be able to perform cGMP biological testing (bioassays, flow cytometry, qPCR, and ELISA)
Review and data entry for testing results following GMP regulations into the electronic data management systems
Perform laboratory investigations for out of specification and/or out of trend results
Write change controls and work orders for systems and instrumentation changes
Creation/Revision of SOP's, and other documents required to support testing and ensure compliance
Participate in non-routine projects, validations and method development to meet departmental and individual goals
The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed.
Experience with the execution of test methods for sterile and non-sterile drug products, 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 bring resolution
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
Experience of Thermo Sample Manager LIMS or other applicable LIMS systems
The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the laboratory, aseptic gowning, and no health conditions that would prevent them from doing so
Optional:Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods like ELISA is an added advantage
Preferred Technical Abilities and Personal Skills
Ability to work safely; seek out and encourage safe practices
Ability to focus attention to details and ensure high quality work
Ability to cope with a rapidly changing work environment
Self-starter that takes initiative to do work with minimal supervision
Time management skills
Commitment to teamwork
Commitment to continuous improvement
Effective communication with co-workers and supervisors
Education and Experience:
Bachelor's in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required
For QC Analyst I role, 1+ year(s) experiecnce in pharmaceutical manufacturing or contract testinglaboratory required
For QC Analyst II role, 2+ years experience in pharmaceutical manufacturing or contract testinglaboratory required
This job requires a large amount of physical activity
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending are all required
Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.