What are the responsibilities and job description for the Scientist II - Manufacturing, Science, and Technology position at CEDENT?
Scientist II will support tech transfer activities for plasmids, Gene Therapy Drug Substance (DS), and Drug Product (DP) manufacturing processes. Scientist II will support upstream and downstream process development activities, including bioprocessing and analytics responsibilities. Working in close collaboration with Process Development, Manufacturing, and Supply Chain. The Scientist II will support the execution of Engineering runs, Writing of Risk assessments, and Writing of Batch Records. Design of single-use assemblies and create recipes for bioreactor and chromatography systems. Also, supports process qualification and process improvement activities:
- Supports tech transfer activities for plasmids, and Gene Therapy Drug Substance (DS), and Drug Product (DP) manufacturing proceses.:
- Supports upstream and downstream process development activities, including bioprocessing and analytics responsibilities. Working in close collaboration with Process Development, Manufacturing, and Supply Chain.:
- Supports the execution of Engineering runs, Writing of Risk assessments, and Writing of Batch Records. Design single-use assemblies and create recipes for bioreactor and chromatography systems. Also, supports process qualification and process improvement activities.:
- Process monitoring and general troubleshooting:
- Post-Manufacturing Phase:
- Close-out investigations and data analysis for on-time product release:
- Performs Root Cause Analysis, writes change control justification, and drives continuous improvement and process improvement opportunities:
- Exercise discretion, judgment, and personal responsibility:
- Demonstrate a high level of integrity:
- Maintain a positive attitude:
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products:
- Attention to detail in all job functions:
- Solving, correcting, and preventing problems and performing tasks as assigned by leadership, as well as assigning tasks to junior staff:
- Works on specific measurable objectives requiring operational planning skills with little direct supervision:
- Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals:
- Documentation of all activities performed according to procedures:
- Make decisions based on established procedures:
- Infrequent travel required:
- Moderate involvement in audits:
- Moderate involvement in customer relations:
- Other duties as assigned:
- B.S. Degree in Chemical / Biochemical / Biomedical Engineering, Biological Sciences, Molecular Biology, Virology, or other relevant major with 3 years of progressive related industry experience:
- Experience in biologics or gene therapy is preferred:
- Experience in mammalian cell culture is preferred:
- Experience in chromatography types: affinity, ion exchange, hydrophobic interaction, and multi-modal preferred:
- Experience in Purification: depth filtration, tangential flow filtration, empty/full separation, chromatography, sterile filtration, and final fill of product:
- Prior experience in viral vector space is desirable:
- Ability to communicate clearly with diverse groups of team members:
- Ability to drive sound decision-making:
- Ability to drive the project forward with collaboration:
- Ability to manage projects using project management tools:
- Experience in technical investigations:
- Ability to analyze and resolve technical issues:
- Analyzing, interpreting, and compiling data, logical conclusions, recommendations & decision making:
- Naturally interested in strong documentation practices and detail-oriented:
- Familiarity with software packages like: Visio®, JMP®, and MS Project:
- ®Experience in biologics or gene therapy is required:
- Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change:
- Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word), including data interpretation and reporting:
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment:
- Must possess a client-focused mindset in daily tasks:
- Must possess prior experience handling confidential information and the ability to maintain confidentiality:
