Principal Scientist, MSAT Synthetics Liquid DP

Role Overview

• Handle execution of drug product technology transfer, product life cycle activities, material qualification, and cleaning validation
• Support NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM site
• Act as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology Roadmaps
• Serve as primary contact and site owner for technical issues related to EM and represent in VMT by being a single technical voice including EM, thus supporting decision / actions
• Maintain and develop good understanding of the status regarding ongoing and future planned technical activities at site
• Engage in Site Lifecycle processes (due diligence / selection, onboarding, engage, ongoing monitoring, disengage) including support to localization; also be involved in technical assessment / due diligence of product portfolio / in
• licensing
• Support working models and tools in handling EM from technical perspective which includes Technical risk metrics & Switching Effort / Complexity metric for fit-for-purpose segmentation model, and account planning/adherence
• Conduct technical assessment of change controls and other quality related activities by associating with Quality for audits and inspections
• Provide technical support on site for investigations and resolution of deviation / OOS (process, cleaning, troubleshooting) by collaborating with engineering, product launch, and technical owners

Requirements

• Minimum of a Bachelor's/University or equivalent degree required
• Master's or PhD and/or focused degree specialization in Engineering, Pharmaceutical Science, or equivalent technical subject is preferred
• Minimum 8 years of relevant work experience
• Demonstrated experience/expertise with various dosage forms, including experience in process science and tech transfer of Liquid & solids manufacturing technology.
• Experience working with external manufacturing network (EM)
• Basic knowledge of Small Molecule Supply chain (products, customers, suppliers, plants)
• Strong communication and teamwork/networking skills with the ability to interact at different levels of the organization/sector
• Ability to lead activities under general direction, and demonstrate a good sense of prioritization of assigned tasks & goals and handle time accordingly
• Strong understanding and knowledge of Q&C (Quality & Compliance) and the regulatory requirements (e.g., GMP, EHSS, etc.) related to pharmaceutical manufacturing environment.
• Preferred: Experience in specialized technology which includes Freeze dried tablets, Softgel capsules etc., new pharmaceutical manufacturing technology especially continuous manufacturing or related technology.
• Understanding and application knowledge in statistics and process excellence / investigation tools.

Tech Stack

• Switching

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• vacation days
• parental leave for a minimum of 12 weeks
• bereavement leave
• caregiver leave
• volunteer leave
• well-being reimbursement
• programs for financial, physical and mental health.
• service anniversary and recognition awards
• subject to the terms of their respective plans, employees
• and in some location’s eligible dependents
• can participate in several insurance plans.