Summary:
The Manufacturing Scientist will be experienced subcontracted professionals to support the Dry External Manufacturing (Dry-EM) Technical Services / Manufacturing Science pharmaceutical organization. The selected candidates will provide technical leadership and scientific support for spray dry dispersion (SDD), solid oral dosage manufacturing, technology transfer, process validation, continued process verification, deviation investigations, and manufacturing support activities performed by external manufacturing partners. The role requires strong technical expertise, regulatory knowledge, and the ability to collaborate with internal and external stakeholders to maintain compliant and reliable supply of pharmaceutical products.
Responsibilities:
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.
Operate with company mindset, demonstrating a collaborative approach and positive attitude toward change.
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.