Process Engineer Pharmaceuticals

Process Engineer Pharmaceuticals I
RTP NC 27709
6 Months

Description:
Seeking a contract Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support of AAV (rAAV) vector research and late-stage clinical gene therapy programs.
This role is execution-focused supporting upstream and downstream manufacturing operations routine experiments and process development studies working in close coordination with manufacturing and MSAT staff. The contractor will contribute to the timely completion of manufacturing and laboratory studies data collection and manufacturing readiness ensuring alignment with existing protocols to support early-stage gene therapy programs technology development and internal research priorities.
This is a laboratory-based contract role intended to support day-to-day manufacturing and experimental execution working closely with pre-clinical manufacturing and MSAT scientists. This role does not carry people-management or long-term program ownership responsibilities and is well suited for individuals who thrive in an execution-driven environment.
Key Responsibilities
Execute routine and defined rAAV manufacturing and laboratory activities for research and GLP-grade studies following established protocols and batch records.
Perform hands-on upstream and downstream operations including:
o Cell culture and maintenance
o Vector production in shake flasks WAVE bioreactors and/or stirred-tank bioreactors
o Centrifugation filtration chromatography and related purification steps
Support process development and experimental studies including process characterization and robustness testing at small and pilot-scale by executing assigned experiments and manufacturing runs according to approved protocols batch records and study plans ensuring accurate data generation and traceability.
Maintain clear real time and accurate documentation of laboratory activities experimental results and manufacturing data in paper or electronic systems in accordance with department procedures to ensure compliance and data integrity..
Assist with batch record completion data compilation and data review.
Communicate experimental progress observations and results to project stakeholders in a clear and timely manner.
Support manufacturing investigations and troubleshooting activities including execution of confirmatory experiments and data collection to inform root-cause analysis.
Contribute to technical protocols experimental reports and summary presentations describing executed work and generated data as needed.
Support daily laboratory operations including:
o Equipment setup operation and routine maintenance
o Coordination and execution of laboratory activities
o Maintaining a clean organized and inspection-ready lab environment
o Ensuring materials consumables and reagents are available for assigned experiments in coordination with lab management and solution prep teams.
Follow established safety procedures SOPs and documentation practices at all times.
Adhere to all safety quality and data integrity requirements during laboratory and manufacturing-support activities.
Required Qualifications
BS or MS degree in a biological or engineering discipline required (Biotechnology Chemistry/Biochemistry Chemical/Biochemical Engineering or equivalent)
Minimum 2 years (BS)/0 years (MS) of relevant experience in laboratory research biologics manufacturing and a desire to continue in a laboratory-focused role preferably within:
o Manufacturing
o MSAT
o Process Development
Experience or familiarity with upstream and/or downstream bioprocess operations
Comfort executing experiments under direction following protocols and meeting scheduled deliverables
Ability to work on-site in a fast-paced laboratory environment
Preferred Experience
Prior exposure to cGMP manufacturing environments or manufacturing-support laboratories
Hands-on experience executing scale-up scale-down or process characterization experiments
Familiarity with DOE concepts and experimental execution (design and analysis support may be provided by others)
Experience using JMP or similar statistical tools (execution-focused)
Strong working knowledge of Microsoft Word Excel and PowerPoint
Excellent attention to detail and data accuracy
Ideal Contractor Profile
Execution-oriented with a strong preference for hands-on laboratory work
Comfortable working under established protocols and technical direction
Organized reliable and able to manage assigned experiments independently once trained
Adaptable to changing project priorities and manufacturing timelines
Collaborative team player who communicates clearly with scientists engineers and manufacturing stakeholders
Willing to support on-site manufacturing or lab schedule needs including periodic weekend coverage.


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