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Principal Scientist
mîrus 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 project management involved.
Position Summary
The Principal Scientist is accountable for the transfer, project management, optimization and daily support of manufacturing processes across the site, and for the timeliness of introduction, robustness of the processes, and quality of the products transferred from Research and Development, other BMS sites, in order to satisfy or exceed established timing targets and business plans.
The incumbent is the principal subject matter expert and process owner for the end-to-end manufacturing process for liquid and lyophilized parenteral products. The position ensures processes are designed and validated per applicable cGMPs and site procedures, and that processes are defined consistently with regulatory filings.
Key Responsibilities
Position Summary
The Principal Scientist is accountable for the transfer, project management, optimization and daily support of manufacturing processes across the site, and for the timeliness of introduction, robustness of the processes, and quality of the products transferred from Research and Development, other BMS sites, in order to satisfy or exceed established timing targets and business plans.
The incumbent is the principal subject matter expert and process owner for the end-to-end manufacturing process for liquid and lyophilized parenteral products. The position ensures processes are designed and validated per applicable cGMPs and site procedures, and that processes are defined consistently with regulatory filings.
Key Responsibilities
- Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes and formulation, maintaining a current knowledge base of best industry practices.
- Supports Technical Transfer projects, including project plan development, team formation and charters for new product transfers occurring.
- Develops and executes technology transfer plans in support of new products, effectively integrating site time and event schedules to priorities established through corporate structures.
- Acts as a core team member on new product introduction teams for internal R&D, contract-manufactured and Alliance products (e.g., Integrated Development Team, Tech Transfer Team).
- Partners with Information Management, Engineering Maintenance and Manufacturing to ensure equipment and automation are capable of delivering the manufacturing processes transferred.
- Assures effective integration of plans and resources to achieve timeliness of process support, productivity, and technology transfer and validation activities associated with the product portfolio.
- Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies and to perform equipment characterization exercises.
- Partners with the site management team in the identification of industry best practices related to technology transfers and pharmaceutical technology, to create a competitive advantage.
- Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, productivity and process support activities.
- Leads, motivates, mentors and provides technical leadership to junior scientists, and develops team members to meet and exceed plant and company goals and objectives.
- Performs as the communication liaison for the transfer, validation, optimization and daily support activities for the assigned product portfolio.
- Performs as the site liaison and primary author for process sections of CMC submissions.
- May represent the site and lead site Technology Transfer Teams to assure timely delivery of targets.
- May be the approver on validation and experimental protocols.
- Bachelor’s degree in Pharmacy, Engineering, Chemistry or Science.
- Seven (7) years of directly related experience in Technical Services work within the pharmaceutical industry.
- Three (3) years of experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.
- Subject Matter Expertise in industrial parenteral formulation and filling processes.
- Strong knowledge and practical experience in manufacturing processes, technologies and processing equipment, cGMPs, and FDA regulations and trends.
- Engineering principles aptitude.
- Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
- Strong project management skills and experience.
- Excellent analytical and strategic thinking skills and experience.
- Ability to effectively lead cross-functional site teams toward execution of technical transfer activities.
- Ability to work in a fast-paced, complex and changing environment.
- Ability to manage personnel and financial resources.
- Demonstrated lead management, interpersonal and teamwork skills. Strong mentor, with excellent people development skills and track record.
- Outstanding communication skills in both English and Spanish (oral and written).