Process Development Sr. Associate Scientist (Biotechnology)
Job Title: Process Development Sr. Associate Scientist
Industry: Biotechnology/Drug Product
Location: East Region, Puerto Rico
Schedule: 100% Onsite | Administrative Shift
Duration: Approximately 1 Year
Openings: 1 Position
Summary
We are seeking a Process Development Sr. Associate Scientist with experience in inspection (manual/automatic), packaging, primary containers, forensics, or quality control (QC) defect analysis. This position is critical to our client’s Process Development-Drug Product organization and requires hands-on expertise in materials analysis, defect identification, and scientific research within a lab setting. The selected candidate must be fully bilingual (English/Spanish) and possess strong technical, analytical, and communication skills.
Preferred Qualifications
- Experience in:
- Manual and automated inspection
- Packaging processes
- Incoming material inspection (e.g., primary containers)
- Forensic analysis or Quality Control (QC) of defects
- Willingness to work in a Process Development laboratory environment
Key Responsibilities
- Monitor developments in scientific literature and technology related to the field and share relevant insights
- Understand and interpret primary container component specifications and methods
- Demonstrate knowledge of metal, glass, and polymer formation processes and classification of container defects
- Perform evaluations of primary packaging and forensic analysis of glass and polymer materials
- Develop and implement scientific protocols and advanced methodologies
- Represent the department in cross-functional project teams under supervision
- Collaborate across departments within and outside the Process Development organization
- Support experimental design and data interpretation; suggest innovative solutions
- Independently author scientific reports, summary documents, regulatory filings, invention disclosures, and patents
- Contribute to external scientific engagements and departmental initiatives such as safety or operational excellence
Technical Responsibilities
- Conduct research into the structure and properties of materials (e.g., metals, polymers, ceramics)
- Develop or enhance materials with specific properties for use in pharmaceutical products
- Plan and execute lab experiments to validate production processes and materials
- Design testing methods for evaluating material behavior under different conditions
- Perform and document laboratory work with minimal supervision
- Generate reliable data in compliance with SOPs, protocols, and cGMPs
- Identify and resolve technical issues related to container defects
- Evaluate materials using imaging acquisition systems and specialized lab equipment
- Conduct root cause analyses of container failures due to tension, compression, and shear
- Ensure compliance with internal and regulatory quality and safety standards
- Maintain laboratory supplies and sample inventories
- Participate in routine peer review and collaborate on shared project goals
General Requirements
- Demonstrate the ability to:
- Work independently and manage multiple scientific tasks
- Complete assignments involving complex scientific/engineering methods
- Lead or contribute to department-level initiatives (e.g., safety, recruitment)
- Support projects involving the development of new lab methods and instruments
- Strong problem-solving and critical-thinking skills at the project level
- Excellent technical writing and data interpretation skills
- Flexibility to support non-standard shifts as needed by business operations
Education & Experience
- Master’s Degree with a minimum of 3 years of directly related experience
- OR
- Bachelor’s Degree with a minimum of 5 years of directly related experience
Core Competencies & Skills
- Advanced scientific analysis and troubleshooting abilities
- Proficiency in laboratory techniques and experimental design
- Strong organizational and multi-tasking capabilities
- Effective verbal and written communication, including technical writing
- Skilled in negotiation, conflict resolution, and project management
- Adaptable to change with a continuous improvement mindset
- Strong computer literacy and use of scientific software tools
- Comprehensive knowledge of cGMPs and good documentation practices
- Fully bilingual (English/Spanish)
Interested candidates are encouraged to apply by submitting their application through the job description link with an updated resume.