Posted in Other 30+ days ago.
Type: Full Time
Perform all necessary operations activities related to recrystallization and micron-suspension . These activities include, but are not limited to the following: batch records, operating procedures, equipment manuals, various specifications, cleaning, sterilization, filtering, transferring materials aseptically, and various other GMP-related tasks. Other responsibilities include SOP writing, and reviewing GMP documentation.
Document all work as required by cGMPs on a timely basis.
Executes tasks as directed
Monitors Process with close attention to detail
Abide by all safety requirements as defined by the company.
Can work independently without constant supervision
Follows Alkermes internal policies
Works well in a team environment
Perform facility / equipment cleaning and set-up.
Assist with Development activities and Validation as required.
Perform aseptic operations.
Other tasks as assigned by Manager.
Shift coverage and weekend work may be required
Minimum Education & Experience Requirements:
High School diploma or equivalent. 1-2 years of manufacturing experience.
2 year degree (4 year degree preferred) in a science/technical discipline and/or 5 years relevant Pharmaceutical experience.
Knowledge / Skills Needed:
General math skills; including simple algebra.
General knowledge of and adherence to Current Good Manufacturing Practices.
General knowledge of HAZCOM, RCRA, and other Safety requirements.
Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment
General computer word processing/spreadsheet skills.
Good written communication, and documentation skills.
Ability to lift / move 40lbs. overhead.
Ability to operate all types of production equipment (i.e. Autoclave, HMI panels, pumps, motors, etc.).
Ability to gown in an aseptic manner for clean room operations.
Ability to read, understand and accurately follow company SOPs and guidelines.
Personal Attributes Needed:
Willing to learn new tasks, skills.
Works well in a team environment.
Responds quickly to assignments.
Readily adapts to changing job duties.
Manages time well; ability to multi-task
Effective communication skills, written and verbal
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.