Engineering - Assistant/Associate Scientist

TechDigital Group; Harvard (MA); Hybrid; USD 70,000 - 100,000; Full time

Job summary

A leading company seeks an Assistant/Associate Scientist to provide technical expertise for commercial manufacturing processes within a biopharmaceutical context. Responsibilities include developing protocols, supporting regulatory filings, and authoring technical documents. This role requires a strong background in chemical/biochemical engineering and prior experience in compliance and project management.

Qualifications

• 4-7 years relevant industrial and/or academic experience.
• Knowledge in upstream & downstream unit operations.

Responsibilities

• Provides technical expertise for large-scale commercial manufacturing.
• Develops and executes protocols to support qualification and validation activities.
• Authors technical documents, including protocols, reports and SOPs.

Skills

Technical expertise

Data collection and analysis

cGMP compliance

Technical writing

Education

MS or BS in Chemical/Biochemical Engineering

Job description

Assistant/Associate Scientist
Onsite required for Training
Hybrid 50/50 once training is successfully completed
Work Schedule: Mon - Fri, Business Hours *Some weekends required based on the needs of the Business*

• Provides technical expertise for large-scale commercial manufacturing involving column chromatography, microfiltration, ultrafiltration, nano-filtration, and cryogenics / drug substance handling unit operations for investigation and resolution of process deviations, development, andinterpretation of data trending.
• Develops, drafts and executes protocols per corporate, site and regulatory requirements to support qualification and validation activities.
• On-the -floor support for process related issues
• Performs data collection and analysis for process monitoring
• Demonstrates a strong knowledge of cGMP compliance, Client corporate, site and regulatory agency requirements and procedures and incorporate into all assigned projects.
• Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for Client Devens Large Scale Cell Culture & Single Use facility.
• Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
• Knowledge or experience in upstream & downstream unit operations and technical writing (validation and regulatory document authoring) attained through prior experience or studies resulting in a B.S. in biology, chemistry, and/or engineering, a related discipline, or its equivalent.

Education and Experience:
•MS or BS in Chemical/Biochemical Engineering or related field with 4-7 years, respectively, or relevant industrial and/or academic experience

Additional Job Requirements:
Position Handles Hazardous Materials