Job Description:

The Quality Control Chemistry Team Leader/QC SPECIALIST V will be the technical leader responsible for the technical work for a small group of chemists performing testing to meet QC cycle times and to comply with all Alkermes criteria and cGMP regulations. He/she will apply knowledge, experience and initiative in resolving highly complex non-standard problems and developing recommendations.

Responsibilities:

• Recognize and takes ownership when problems occur, makes necessary decisions and escalates as necessary.


• Communicates decisions to wider group and follows up to ensure compliance with decision.


• Accountable for all people management, technical and scheduling issues in the absence of the supervisor.


• Leading and participating in improvement projects.


• Lead Root Cause Analysis process and write up within department complex issues, identify the solution and implement.


• Monitor the effectiveness of preventative measures and has the ability to re-assess and continuously improve.


• Adapts to changes to ensure all work schedule activities are completed as required.


• Independently coordinates activities with others both inside/outside their area.


• Prepares/ facilitates peer to peer shift handover and resources for areas of their responsibility in the absence of supervisor.


• Acts as a positive role model to all team members' e.g punctual, prepared and high standards.


• Takes responsibility for Lab Services within all discussions; owning the opinion managing risk and assessing impact.


• Acts as a coach and mentor to other team members.


• Understands how own contribution impacts site goals.


• Train other group members.


• Troubleshooting methods and equipment.


• Performing analyses.


• Reviewing and reporting test results.


• Developing new methods as necessary.


• Writing and reviewing deviations/ lab investigations.


• Writing and reviewing test methods, reports and validation protocols.


• Conducting method transfers and validations.

Qualifications:

• Bachelors Degree in Chemistry with approx. 8 years of laboratory experience or


• Masters Degree in Chemistry with approx. 5 years of laboratory experience


• Ability to manage technical issues and root cause analysis


• Ability to represent self in a regulatory inspection


• Specific understanding of the instrumentation and practices of LC, GC, GPC, particle size analysis, DSC, Karl Fischer titrator, FTIR spectrophotometer etc.


• Specific understanding of chromatographic data acquisition and analysis software (empower), LIMS, SAP, track-wise etc.


• Specific understanding of the application of statistical concepts to the calibration of assays and interpretation of results.


• Knowledge of analytical instrumentation such as GPC, particle size analyzer, and/or.


• Ability to manage technical issues and troubleshoot across a shift and cross functionally where required.


• Adapting to changing priorities (positively/ constructively)Ability to anticipates problems ahead of time and develops solutions.


• Ability to influence, listening & values/recognition of all opinions and represents Lab services in a diplomatic way facilitating open discussion across all functions.


• Ability to work hard and contribute to an enjoyable rapidly changing working environment.


• Proactively achieves results for the best of the organization.

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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.

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