POSITION SUMMARY

In the assigned manufacturing area, directly supports the Aristada Manufacturing Process. Actively supports ongoing manufacturing efforts in terms of quality and efficiency, provides an interface with Development and Engineering in technology transfer of new processes and process upgrades to existing technologies, and supports Corrective and Preventive Action programs. Conducts real-time monitoring/trending of manufacturing processes and finished product analytical data.

MAJOR RESPONSIBILITIES

• Develops and maintains databases that provide trending capability for process parameters.
• Develops and maintains (tracks) Aristada production metrics using analytical tools.
• Conducts frequent and thorough periodic reviews of the database and trends, identifying opportunities for improvement in performance in process, manpower effectiveness, and efficiency.
• Actively identifies unfavorable trends and investigates root cause as well as effective preventive actions.
• Provides leadership and manufacturing support in investigations, as assigned.
• Assures the resolution of deviations, corrective actions, Change Control action items, and any audit non-compliance items.
• Ensures the timely completion of assigned deviations and CAPAs
• Performs process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes.
• Writes/revises, develops, and implements SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
• Establishes familiarity with all manufacturing activities involved in the sterile production process to share best practices and streamline operations.
• Develops and implements effective training of manufacturing personnel related to technical transfer and process upgrades.
• Acts as a manufacturing liaison in project planning and coordination.
• Represents manufacturing on process design teams.
• Champions projects as they move into and through the manufacturing areas.
• Authors, drives, and assures accurate and timely execution of process Change Controls; Partners with other bulk groups when necessary.
• Provide regular updates to manufacturing management on the status and issues involved in projects.
• Performs troubleshooting of issues and non-conformance items
• Provides administrative support to manufacturing in authoring and reviewing engineering/validation documentation, as assigned.
• Supports manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regard to (but not limited to) Operability, Technical accuracy, Compliance, and Process Robustness.
• Supports production of pharmaceutical formulations.
• Maintains individual training proficiency; Trains operators on processes.
• Documents all work as required by cGMPs on a timely basis.
• Abides by all safety requirements as defined by the company.
• Assists with RCRA and safety inspections, as required.
• Other tasks as assigned by management.t
• Working conditions will mix office work and on-the-floor (cleanroom) production support.  May require occasional off-shift and/or weekend support (< 10%)

COMPETENCIES

• Strong knowledge of pharmaceutical manufacturing processes
• Working knowledge of Good Manufacturing Practices (US and EU)
• Ability to quickly understand detailed and complex processes
• Computer proficiency with JMP, Microsoft Word, Excel, PowerPoint

Physical Requirements:

• Occasional periods of repetitive motion.
• Ability to gown in an aseptic manner for clean room operations. 
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. 
• Ability to operate all types of production equipment 
• Ability to read, understand, and follow company SOP guidelines.
• Ability to lift/move up to 50 lbs.  Ability to team lift up to 100 lbs.
• Ability to stand in steel-toed shoes for a minimum of 7 hrs. 

EDUCATION AND EXPERIENCE

Basic Requirements

• BS Degree or equivalent experience
• 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting

Preferred Requirements

• BS Degree in Engineering, Chemistry or Biology
• Experienced working on (and coordinating of) multiple projects in an orderly and efficient manner while consistently meeting established deadlines.
• Experienced in working successfully across departments to meet company objectives.

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.