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 II/III - Micro
Requires a highly motivated and knowledgeable Microbiologist for the QC Microbiology Technical Services group. The group will be responsible for all Microbiological related projects across multiple sites which includes but is not limited to the identification and procurement of new equipment/technologies, coordinating feasibility studies, method development and validation of microbiological methods, supporting investigations for manufacturing and the QC Microbiology, and supporting audits for regulatory agencies and customers.
The QC Analyst must be a competent professional who is able to network with internal colleagues and external vendor representatives, consultants and other professionals. Using this network and their own experience and expertise, they are able to develop creative and compliant solutions to challenges. They must be familiar with the common techniques and equipment within a pharmaceutical microbiology laboratory and the regulation and guidance that govern them. As the Subject Matter Expert on laboratory equipment and methods, they must be an approachable and experienced trainer capable of clearly articulating technical details.
The individual will have the responsibility for technical support of existing in-process and release assays, the microbial identification program, and assist with the introduction of new Rapid Microbiology Methods (RMM). This position is responsible for providing strong scientific and validation input for all projects within the Microbiology group, e.g., implementation of RMM instrumentation, microbial identification program, method transfers and validations, particulate profiling, and other compendia tests. This position requires cross-functional collaboration with other departments including Manufacturing, Process Development, Validation, and Quality to provide support of site validation studies, microbial studies, and new product(s) implementation.
- BSc In science related field rquired
- For QC Analyst III: 5+ years of experience in pharmaceutical manufacturing or equivalent
- For QC Analyst II: 2+ years of experience in pharmaceutical manufacturing or equivalent
- Able to work autonomously, receiving general instructions on new assignments
- Strong technical knowledge of microbiological test instrumentation and method development / validation including software/computer system validation.
- Experience with the execution and validation of microbiological test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing; this includes the methods described in USP Chapters 61, 62, 71, 85, 788, 790 and relevant informational chapters
- Knowledge of current compendia requirements for microbiological testing.
- Excellent organizational, planning and scheduling skills: Capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor.
- Critical, Fact-Based Decision Making: Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations
- Personally Accountable: Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally
- Agility: Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances
- Good verbal and written communication skills; confident presenter, clear, concise technical writer
- Familiar with common MS Office software packages
- Lead specific aspects of a project, guide solutions for difficult problems, execute project tasks. Identify best solutions based on project requirements
- Write, revise or review equipment and method qualification protocols/reports, engineering studies, SOP's, specifications, and assigned sections of regulatory filings
- Write or review deviation investigation reports
- Establish and manage relationships with equipment vendors and contract laboratories
- Serve as subject matter expert for training, operation and troubleshooting of select laboratory instrumentation and procedures
- Ability to serve as backup support for microbiological testing activities as needed.
- Participates in investigations, and CAPA implementation. Participates in resolution of microbiological excursions.
- Supports manufacturing and validation activities including Aseptic Process Simulations/Validations and Cleaning Validations as needed.
- Develops and maintains effective working relationships with key internal/external customers.
- Responsible for providing project updates to QC Management, and other relevant stakeholders as needed.
- Act as team liaison to include Product Testing Support and Environmental Monitoring groups in specified projects.
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.