MS) Scientist

BioPharma Consulting JAD Group

About The Position

Under limited supervision, the Technical Services / Manufacturing Science (TS/MS) Scientist – Dry External Manufacturing provides technical oversight for spray-dry, solid-dosage manufacturing, and packaging processes, drawing on a strong technical foundation and prior experience with these processes. The role supports resolution of technical issues, including those related to control strategy and manufacturing, and requires strong technical writing, including authoring deviations and change controls. The scientist participates in root-cause investigations to support timely CAPA closure and communicates with external partners, site management, and cross-functional teams. The role also builds and maintains relationships with development and central technical organizations. The position ensures that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state. It supports documenting and justifying process-validation status using data that evaluates whether processes can meet their stated purpose, and maintains compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance. Responsibilities include supporting ongoing external-partner manufacturing through process monitoring, issue response, and process improvements; supporting technical transfers and validation at external manufacturing and packaging sites; reviewing transfer documentation; participating in process qualifications; and supporting validation campaigns. The role works cross-functionally to deliver technical objectives. Flexibility may be needed to support 24/7 operations and resolve issues with external partners across time zones. The stated contract duration is six months, with possible extension.

Requirements

Bachelor's degree at minimum in Chemistry, Pharmacy, Engineering, or another scientific discipline.
At least 5 years of hands-on working experience and proficiency with spray-dry, solid-dosage manufacturing, and packaging.
Working knowledge of cGMPs and applicable global regulatory guidance.
Strong understanding of regulatory requirements and their application in a manufacturing environment.
Proficiency in data management practices across manufacturing and packaging operations.
Ability to communicate effectively and influence diverse technical and business teams.
Demonstrated project-management expertise coordinating and executing multifaceted projects.
Adaptability, a collaborative mindset, and a positive attitude toward change.
Availability to support 24/7 operations and issue resolution across multiple time zones as needed.
Fluency in English and Spanish, with the ability to communicate effectively across diverse teams and stakeholders.
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.

Responsibilities

Provide technical oversight for spray-dry, solid-dosage manufacturing, and packaging processes.
Participate in resolution of technical issues, including control-strategy and manufacturing issues.
Author technical documents, including deviations and change controls.
Participate in root-cause investigations and support timely CAPA closure.
Manage relationships and communicate with external partners, site management, and cross-functional teams.
Build and maintain relationships with development and central technical organizations.
Ensure manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
Understand, justify, and document process-validation status using data that evaluates process capability.
Maintain compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
Support ongoing external-partner manufacturing through process monitoring, issue response, and process improvements.
Support technical transfers and validation activities at external manufacturing and packaging sites by reviewing transfer documentation, participating in process qualification activities, and supporting validation campaigns.
Work cross-functionally within the site and with other functions to deliver technical objectives.
Provide support for 24/7 operations and issue resolution across time zones as needed.