Senior Parenteral Process Scientist & Tech Transfer Lead

Mirus Consulting Group; Manatí (PR); Presencial; USD 150.000 - 210.000; Tempo integral

Resumo da vaga

mîrus Consulting Group in Humacao, Puerto Rico seeks a Principal Scientist to oversee transfer, validation and daily support of manufacturing processes for liquid and lyophilized parenteral products. You will ensure processes meet cGMP standards and regulatory expectations while delivering on timelines and product quality.

You will lead technology transfer activities, collaborate with R&D, site teams and external partners, and mentor junior scientists to achieve site goals and continuous

Qualificações

• Bachelor’s degree in Pharmacy, Engineering, Chemistry or Science.
• 7 years of directly related experience in Technical Services work within the pharmaceutical industry.
• 3 years of experience in parenteral manufacturing of protein therapeutics (biologics).
• Subject Matter Expertise in industrial parenteral formulation and filling processes.
• Strong knowledge and practical experience in manufacturing processes, cGMPs, and FDA regulations.

Responsabilidades

• Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes and formulation.
• 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.
• Acts as a core team member on new product introduction teams for internal R&D, contract-manufactured and Alliance products.
• 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.
• 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 identifying industry best practices related to technology transfers and pharmaceutical technology.
• Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, productivity and process support activities.
• Leads, mentors and provides technical leadership to junior scientists, and develops team members to meet and exceed plant and company goals.
• Performs as the communication liaison for 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.

Conhecimentos

Parenteral formulation

Technology transfer

Project management

Cross-functional leadership

cGMP knowledge

FDA regulations

Process validation

Formação

Bachelor's degree

Descrição da vaga

mîrus Consulting Group in Humacao, Puerto Rico seeks a Principal Scientist to oversee transfer, validation and daily support of manufacturing processes for liquid and lyophilized parenteral products. You will ensure processes meet cGMP standards and regulatory expectations while delivering on timelines and product quality.

You will lead technology transfer activities, collaborate with R&D, site teams and external partners, and mentor junior scientists to achieve site goals and continuous