Top 3 Must Have Skill Sets:
Cell Culture execution and /or support (3 or more years)
Microsoft Office (expert level)
Onsite - orientation will be virtual
***working on site 2-3 days a week***
3 or more years of experience in Cell Culture execution and /or support, GMP experience, Development of regulated or process documents with the ability to deliver high quality documentation including technical writing. The primary responsibilities may include, but are not limited to the following:
• Support of manufacturing operations
• Management of Manufacturing process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Initiating and owning minor deviations
The creation and/or revision of materials such as SOPs, manuals, and related business process documentation may take place virtually and across different time zones and in conjunction with Subject Matter Experts, other members of the Manufacturing Support Team and business (e.g. Business Process/System Owner, Document Owner, Authors, Subject Matter Experts). Document revisions are managed using the electronic document repository and tracked by project inventory tool and key Points of Contact.
• Single use technology experience
• Upstream / Cell Culture execution and /or support experience
• Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing
• Microsoft Office (expert level)
• Ability to interpret and apply GMP knowledge
• Ability to work independently and as a team player
• Excellent collaboration and people management skills
• Experience in leading virtual teams within different regions and cultures.
• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
• Mechanical expertise
• Basic statistical and mathematical skills
• Understanding of analytical methods for manufacturing area
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on Manufacturing equipment including single use equipment
• Regulatory knowledge and experience with regulatory audits
• Experience with DeltaV and MES
• Experience with lab equipment/testing
• Preferably to include experience in influencing and negotiation.
"This posting is for Contingent Worker, not an FTE"