Overview
On Site
Full Time
Skills
Process Modeling
Supervision
Design Of Experiments
Technology Transfer
Manufacturing Operations
Root Cause Analysis
Product Design
Presentations
Network
Pharmaceutics
Biotechnology
Inspection
Conflict Resolution
Problem Solving
Communication
GMP
Statistics
Quality Management
Analytical Skill
Science
Process Engineering
Project Management
Manufacturing
Regulatory Compliance
Organizational Skills
Job Details
Hybrid - 2-3 days onsite per week. Flexibility for more onsite requirements may be necessary.
Ideal candidate: B.S. and 2YOE in Pharma.
Nice to have: Drug product experience
As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.
Key responsibilities include:
Supports the establishment of robust tactical and strategic objectives related to visual inspection
Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels, establishment of GMP procedures related to operations)
Implements and documents off-line and on-site drug product characterization studies
Author and/or own high-quality process technology transfer and other technical documents
Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
Support one or more clinical and commercial process introductions or process transfers into Client manufacturing network
Preferred Qualifications
2+ years of experience within the pharmaceutical/biotechnology industry
Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
Ability to learn and act on dynamic information at a rapid pace
Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
Strong knowledge of quality systems and drug product manufacturing
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Capable of organizing and communicating complex technical concepts to enable business decisions
Ideal candidate: B.S. and 2YOE in Pharma.
Nice to have: Drug product experience
As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.
Key responsibilities include:
Supports the establishment of robust tactical and strategic objectives related to visual inspection
Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels, establishment of GMP procedures related to operations)
Implements and documents off-line and on-site drug product characterization studies
Author and/or own high-quality process technology transfer and other technical documents
Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
Support one or more clinical and commercial process introductions or process transfers into Client manufacturing network
Preferred Qualifications
2+ years of experience within the pharmaceutical/biotechnology industry
Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
Ability to learn and act on dynamic information at a rapid pace
Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
Strong knowledge of quality systems and drug product manufacturing
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Capable of organizing and communicating complex technical concepts to enable business decisions
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.