DRY-EM TS/MS Scientist

Weil Group, Inc; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. seeks a Scientist to provide technical and scientific expertise in external manufacturing for spray dry dispersion and solid dosage forms at contract manufacturers, aligned to global quality standards.

You will oversee spray dry and solid dosage processes, participate in CAPA closures, and maintain compliance with cGMPs while coordinating with external partners and cross-functional teams.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, or Engineering is required.
• 5+ years of hands-on spray dry solid dosage and/or packaging manufacturing experience.
• Working knowledge of cGMPs and global regulatory guidance.
• Strong understanding of regulatory requirements in manufacturing settings.
• Proficient data management across manufacturing and packaging operations.
• Excellent communication and ability to influence across diverse teams.

Responsibilities

• Provide technical oversight for spray dry and solid dosage manufacturing and packaging.
• Resolve technical issues related to control strategy and manufacturing processes.
• Draft deviations and change controls; support CAPA closures with timely investigations.
• Communicate effectively with internal and external partners and cross-functional teams.
• Foster relationships with development and central technical organizations.
• Ensure manufacturing processes are compliant, validated, and in control.
• Document process validation states with data demonstrating capability.
• Maintain compliance with US and global regulations (cGMPs, regulatory guidance).
• Support external partner manufacturing through process monitoring and improvements.
• Assist with technical transfer and validation activities at partner sites.
• Collaborate across site functions to meet technical objectives.
• Be flexible to support 24/7 operations across time zones.

Skills

Spray dry process

Solid dosage manufacturing

Regulatory compliance

Data management

Cross-functional communication

Project management

Bilingual English/Spanish

Education

Bachelor's degree in Chemistry, Pharmacy, or Engineering

Tools

SAP

TrackWise

Job description

The Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment, supporting the reliable and compliant manufacture of spray dry dispersion and solid dosage forms and packaging at external contract manufacturing groups to predetermined global quality standards.

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 'Team's mindset, demonstrating a collaborative approach and positive attitude toward change.
• Comply with all site training, policies and procedures.

MINIMUM 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 dosageand/or packaging manufacturing.
• 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.

Highly Desired

• 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

Weil Group is proud to be an Equal Employment Opportunity Employer.