Support and assist in the manufacture of pharmaceutical products for commercial and clinical supplies. Scale-up and transfer formulations/processes to production facility, design and recommend equipment purchases, write and execute qualification/validation protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control system) to reduce waste and increase process reliability. Support of manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to, but not limited to, Operability, Technical accuracy (technical reviews), Compliance, Process Robustness. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes, Write or revise SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel, Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Develop and implement SOPs in support of new and upgraded processes, Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades, Represent manufacturing on process design teams, Champion projects as they move into and through the manufacturing areas, Provide regular updates to manufacturing management on the status and issues involved in projects.
BS degree in Engineering or technical discipline.
1 year of manufacturing experience or technical experience.
1-2 years of Sterile pharmaceutical experience or 5 years of pharmaceutical engineering experience.
Experienced working on (and coordination of) multiple projects in an orderly and efficient manner; while consistently meeting established deadlines
Experienced in working successfully across functions to meet company objective.
Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as parenteral drug process systems and equipment.
Thorough knowledge of automated control systems.
Thorough knowledge of computer systems operation and software.
Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
Thorough knowledge of chemistry, statistics, equipment design, process control, and process scale-up.
Knowledge of sterile pharmaceutical operations and equipment validations.
"Hands-on" ability to install and troubleshoot instrumentation and equipment.
Ability to troubleshoot and maintain manufacturing systems, equipment and processes.
Ability to author high quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS).
Ability to specify and size manufacturing systems, equipment and process equipment.
Ability to gown in an aseptic manner for clean room operations.
Ability to read, understand and accurately follow company SOPs and guidelines
Demonstrated ability to deal effectively across multiple functional departments in a matrixed product team structure.
Presentation abilities to technical and management teams
Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc
Adaptable to changing priorities
Personal Attributes Needed:
Excellent communication and documentation skills.
Excellent organizational skills.
Ability to self-manage and prioritize workload.
Ability to react quickly to understand and solve problems.
Excellent troubleshooting skills.
Fosters collaborative relationships within and across groups through influencing and negotiation skills
Logical problem solving skills
Effectively manage conflict and differences of opinion
Ability to operate all types of production equipment.
Ability to lift / move 40lbs. overhead. Ability to team lift up to 100 lbs. Ability to operate all types of production equipment. Ability to gown correctly for clean room manufacturing operations. Ability to read, understand and accurately follow company SOPs and guidelines. Ability to stand or sit for extended periods of time (up to 2 hours at a time). Must be able to work in office and manufacturing environment. Some travel required (< 10%). May require occasional off-shift and/or weekend support (< 10%).
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 .