Background
Lead Team in project Coordination and support
Coordinate and support Tech Services Projects, which include:
Assist in the identification of new 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 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
Maintaining inventory of material and reagents for technical services
The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.
Qualifications
BSc In science related field with (min) 10+ years’ experience in pharmaceutical manufacturing
Able to work autonomously, receiving general instructions on new assignments.
Strong technical knowledge of microbiological / Chemistry test instrumentation and method development / validation including software/computer system validation. Preferred: Oral Solid Dose knowledge
Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters and relevant informational chapters.
Knowledge of current compendia requirements.
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.
Personal Attributes
- Motivated self-starter
- Team player
- Committed to quality
- Well organized, efficient worker
- Good problem solver
- Critical, analytical thinker
- Manages multiple duties and projects
- Creative, innovative thinker
- Easily adaptable to change
- Brings closure to work in a timely manner
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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.
