Job description
mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.
Job Description
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
Job Description
- Leads parenteral technology transfer projects for key lifecycle biologic parenteral products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification.
- Development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
- Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
- Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate.
- Responsible to create, maintain and harmonize key tech transfer business processes.
- Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
- Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply.
- Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process.
- Representative on global supply strategy groups/site forums and to relevant stakeholders across the company.
- Leads, motivates, mentors, and develops team members to exceed plant and company goals.
- Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities.
- Bachelor’s degree in Pharmacy, Biochemistry, Engineering or related Pharmaceutical sciences.
- Seven (7) years of directly related experience in Technical Services work within the pharmaceutical industry.
- Three (3) years experience in parenteral manufacturing
- Subject matter expert in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology, lyophilization, pre-filled syringe operations.
- Strong knowledge of global regulatory requirements related to the design and control of these processes.
- Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment.
- Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes.
- Strong oral and written communication skills.
- Ability to work within and lead different technical teams.
- Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
- Experience with project management systems and tools is preferred.
- Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
- Ability to work in a prompt, complex and changing environment.
- Excellent analytical, technical and experiences.
- Demonstrated management, sociable and ability to work in team. Strong mentor, with excellent people development skills and track record.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
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