What are the responsibilities and job description for the Technical Specialist position at The Autumn Group?
General Position Summary
The Manufacturing Science and Technology (MSAT) Small Molecule Drug Product (SM DP) team is responsible for managing small molecule drug product lifecycle from new product launch through commercial production. Vertex utilizes a modern, risk-based, Continuous Process Verification (CPV) approach for all of its commercial products. The Temporary Technical Specialist, plays a key role in driving the workflow for CPV, identifying potential processing improvement opportunities and ensuring Vertex products are manufactured to the highest quality possible.
Key Duties And Responsibilities
The responsibilities of this position may include, but are not limited to, the following:
Supports commercial drug product CPV program by performing analysis of process data with statistical analysis software.
Generates, reviews and quality checks CPV data analysis and reports.
Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
Takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Ops, Regulatory, Development, suppliers, etc.) to ensure timely completion of data analysis and reports.
Effective written and verbal communication skills.
Established organizational skills.
Ability to collaborate in a team setting.
Qualifications
Has an understanding of drug product manufacturing
B.S. (or equivalent degree) in relevant discipline with 1-3 years of experience
Skilled with MS Word and Excel. Proficiency with statistical analysis software such as Matlab, R or JMP is a plus.
Experience with technical writing
An Understanding of pharmaceutical development and manufacturing processes
Hybrid- 3-4 days onsite
The Manufacturing Science and Technology (MSAT) Small Molecule Drug Product (SM DP) team is responsible for managing small molecule drug product lifecycle from new product launch through commercial production. Vertex utilizes a modern, risk-based, Continuous Process Verification (CPV) approach for all of its commercial products. The Temporary Technical Specialist, plays a key role in driving the workflow for CPV, identifying potential processing improvement opportunities and ensuring Vertex products are manufactured to the highest quality possible.
Key Duties And Responsibilities
The responsibilities of this position may include, but are not limited to, the following:
Supports commercial drug product CPV program by performing analysis of process data with statistical analysis software.
Generates, reviews and quality checks CPV data analysis and reports.
Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
Takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Ops, Regulatory, Development, suppliers, etc.) to ensure timely completion of data analysis and reports.
Effective written and verbal communication skills.
Established organizational skills.
Ability to collaborate in a team setting.
Qualifications
Has an understanding of drug product manufacturing
B.S. (or equivalent degree) in relevant discipline with 1-3 years of experience
Skilled with MS Word and Excel. Proficiency with statistical analysis software such as Matlab, R or JMP is a plus.
Experience with technical writing
An Understanding of pharmaceutical development and manufacturing processes
Hybrid- 3-4 days onsite
