Process Development Scientist

*Summary*

We are seeking a highly motivated and technically skilled Process Development Scientist to support commercial biopharmaceutical manufacturing operations. The successful candidate will provide scientific and technical expertise in process development, process monitoring, process optimization, formulation, and aseptic filling operations.

This position will work closely with Manufacturing, Quality, Engineering, and other cross-functional teams to ensure robust manufacturing processes, consistent product quality, regulatory compliance, and continuous improvement.

The ideal candidate has experience in commercial pharmaceutical or biopharmaceutical manufacturing, strong analytical and problem-solving abilities, and the ability to provide technical support in a fast-paced, 24/7 manufacturing environment.

*Key Responsibilities*

* Provide technical and scientific support to commercial biopharmaceutical manufacturing operations.
* Support formulation and aseptic filling processes, including process troubleshooting, technical assessments, and process improvement initiatives.
* Monitor manufacturing process performance, evaluate trends, and identify opportunities to improve process consistency and reliability.
* Analyze manufacturing data using statistical tools and software such as JMP to assess process variability and performance.
* Support process characterization, process optimization, process monitoring, and continuous improvement activities.
* Participate in manufacturing deviations, technical investigations, root cause analysis, CAPA activities, and product impact assessments.
* Evaluate critical process parameters (CPPs) and critical quality attributes (CQAs) to support process understanding and product quality.
* Provide on-the-floor technical support during manufacturing operations, including troubleshooting and resolution of process-related issues.
* Prepare, review, and maintain technical documentation, investigation reports, protocols, and other GMP-related documents.
* Support regulatory inspections and audit readiness through accurate technical documentation and compliance with applicable regulatory requirements.
* Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, and other technical teams to resolve manufacturing challenges.
* Communicate technical findings, present investigation results, and provide recommendations to improve process performance.
* Support projects and technical initiatives from initial assessment through implementation and process verification.

*Qualifications*

Candidates must meet one of the following educational and experience requirements:

* Doctorate degree in a scientific or engineering discipline; OR
* Master's degree in a scientific or engineering discipline and at least 2 years of relevant scientific experience; OR
* Bachelor's degree in a scientific or engineering discipline and at least 4 years of relevant scientific experience.
* Scientific or engineering educational background.
* Relevant experience in commercial pharmaceutical or biopharmaceutical manufacturing environments.
* Understanding of protein science, pharmaceutical formulation, and aseptic filling processes.
* Experience with manufacturing process monitoring, data trending, and statistical analysis.
* Familiarity with statistical analysis tools such as JMP or equivalent software.
* Experience supporting manufacturing deviations, investigations, root cause analysis, CAPA, and product impact assessments.
* Ability to provide technical support on the manufacturing floor in a fast-paced, 24/7 operation.
* Strong technical writing skills and experience preparing GMP documentation and supporting regulatory audits.
* Excellent problem-solving, analytical, communication, presentation, and project management skills.
* Ability to work effectively in cross-functional teams.
* Bilingual proficiency in Spanish and English, both written and verbal.
* Experience supporting commercial biologics manufacturing operations.
* Direct experience with protein formulation and aseptic filling operations.
* Knowledge of process characterization, process validation, and Process Performance Qualification (PPQ).
* Experience evaluating Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
* Experience with deviation investigations, CAPA, process improvements, and technical risk assessments.
* Familiarity with GMP, FDA regulations, and pharmaceutical quality systems.

*Why Join Our Team?*

* Opportunity to contribute to commercial biopharmaceutical manufacturing operations.
* Work alongside experienced professionals in Manufacturing, Quality, Engineering, and Process Development.
* Participate in technical projects focused on process robustness, product quality, and continuous improvement.