Principal Scientist, MS&T

Job Summary

Accountable for the transfer, project management, optimization, and daily support of manufacturing processes across the site and for timeliness of introduction, robustness of the processes, and quality of the products transferred from Research and Development, other BMS sites, or business partners 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 liquids and lyophilized parenteral products at Manatí. Ensures processes are designed and validated per applicable cGMPs, site procedures, and that processes are defined consistent with regulatory filings.

Major Duties and Responsibilities

• Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes, and formulation, maintaining a current knowledge base on best industry practices.
• Supports Manatí Technical Transfer projects, including project plan development, team formation and charters for new product transfers occurring at Manatí.
• 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 core team member on new product introduction teams for internal R&D, contract manufactured, and Alliance products.
• Partners with Innovation Technologies group, Information Management, Engineering Maintenance, and Manufacturing to ensure equipment and automation are capable to deliver 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 to product portfolio.
• Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
• 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.
• 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 author or approver of validation and experimental protocols.

Knowledge / Skill

• Bachelor’s degree in Pharmacy, Engineering, Chemistry, or Science, with 9-12 years of directly related experience in Technical Services work within the pharmaceutical industry, or Master’s with 6-9 years, or PhD with 4-6 years.
• Three (3) years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.
• Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
• Engineering principles aptitude.
• Ability to effectively lead cross-functional site teams towards execution of technical transfer activities.
• Ability to work in a fast paced, complex, and changing environment.
• Ability to manage personnel and financial resources.
• Strong knowledge and practical experience in manufacturing processes, technologies, and processing equipment, CGMPs and FDA regulations and trends.
• Strong project management skills and experiences.
• Excellent analytical and strategic thinking skills and experiences.
• Demonstrated lead management, interpersonal and teamwork skills.
• Strong mentor, with excellent people development skills and track record.
• Outstanding communication skills, both in English and Spanish (oral, written).
• Subject Matter Expertise in Industrial Parenteral Formulation and filling process.