Technical Services / Manufacturing Science (TS/MS) Scientist

Under limited supervision the Technical Services / Manufacturing Science (TS/MS) Scientist – Dry External Manufacturing will performe the following tasks and duties:

• Provide technical oversight for spray dry, solid dosage manufacturing and packaging processes, leveraging a strong technical foundation and previous experience supporting these processes.
• Participate in resolution of technical issues, including those related to control strategy and manufacturing.
• Possess excellent technical writing capabilities, including authoring of deviations and change controls.
• Participating in root cause investigations to support Corrective Actions and Preventive Actions (CAPA) closure Activities within the expected timeline.
• Employ excellent communication skills to manage internal and external relationships with external partners, site management, and cross-functional teams.
• Build and maintain relationships with development and central technical organizations.
• Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.
• Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
• Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.
• Support technical transfer and validation activities to external partners manufacturing and packaging sites by review technical transfer documentation, participate in process qualifications activities and support validation campaigns.
• Work cross-functionally within the site and other functions to deliver on technical objectives.
• Some flexibility may be required to support 24/7 operations and issue resolutions with external partners across different time zones.

Requirements

• Bachelor's degree (minimum) in scientific disciplines of Chemistry, Pharmacy, or Engineering.
• 5+ years of demonstrated hands-on working experience and proficiency with spray dry, solid dosage manufacturing and packaging.
• Working knowledge of regulatory expectations (cGMPs and applicable global regulatory guidance).
• Strong understanding of regulatory requirements and their application in a manufacturing environment.
• Proficient in data management practices across manufacturing and packaging operations.
• Proven ability to effectively communicate and influence across diverse technical and business teams.
• Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.
• Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change.
• Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
• Fluent in English and Spanish, with the ability to communicate effectively across diverse teams and stakeholders.

Must have:

• Experience supporting External Manufacturing Organizations (CMOs).
• Spray Dry Dispersion (SDD) experience.
• Oral Solid Dosage manufacturing experience.
• Technology Transfer experience.
• GMP regulatory inspection support experience.
• TrackWise experience.
• SAP experience.
• Statistical analysis experience.
• FDA regulated manufacturing experience

Benefits

• Work Schedule: Monday-Friday (core business hours) but to support 24/7 Operation as needed (Shift Support May require support outside normal business hours)
• Contract: 6 Months (with possible extension)