Technical Services / Manufacturing Science (TS/MS) Scientist

Biopharma-Consulting-Jad-Group; Carolina (PR); On-site; USD 83,000 - 138,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a TS/MS Scientist – Dry External Manufacturing to provide technical oversight for spray drying, solid dosage manufacturing and packaging at external partners. Strong background in cGMPs and regulatory guidance is required, with 5+ years of hands-on experience and excellent written communication.

The role supports process validation, CAPA, technology transfer, and cross-functional collaboration across sites, with flexibility for 24/7 operations and a 6-month

Qualifications

• Bachelor’s degree in a scientific field required.
• 5+ years hands-on spray dry and solid dosage exp.
• Experience with cGMPs and global regulatory guidance.

Responsibilities

• Provide technical oversight for spray dry, solid dosage manufacturing and packaging.
• Investigate technical issues related to control strategy and manufacturing.
• Author deviations and change controls with strong technical writing.
• Lead root cause investigations supporting CAPA closure timelines.
• Manage internal and external relationships with partners and teams.
• Ensure processes are compliant, in control, and validated.
• Document process validation state with data supporting capability.
• Support external manufacturing partners and tech transfers.
• Work across site functions to achieve technical objectives.
• Support 24/7 operations across time zones as needed.

Skills

Spray dry

Solid dosage

Packaging processes

Regulatory knowledge

Cross-functional collaboration

Project management

Bilingual English/Spanish

Data management

Communication

Education

Bachelor's degree in Chemistry, Pharmacy, or Engineering

Tools

TrackWise

SAP

Job description

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.

• 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

• 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)