Process Development Sr. Associate Scientist (Biotechnology)

Emploi Porto Rico

Titre du poste : Process Development Sr. Associate Scientist (Biotechnology)

Entreprise : Proqualitynetwork

Description du poste : 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 PositionSummary
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.

Salaire attendu :

Localisation : Puerto Rico

Date du poste : Thu, 22 May 2025 22:20:31 GMT

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