What are the responsibilities and job description for the Associate Engineer, Drug Development Process Improvement (JP13693) position at 3 Key Consulting?
Job Title: Associate Engineer, Drug Development Process Improvement (JP13693)
Location: Cambridge, MA. 02138
Business Unit: DST Synthetics B
Employment Type: Contract
Duration: 2 year with likely extensions and/or conversion to a permanent position.
Rate: $30 - $35/hour W2
Posting Date: 02/25/2025.
Notes: Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
As the DST representative you will be responsible to collaborate with the product delivery team(s) to work with the manufacturing organization(s) to ensure drug substance supply and resolve challenges, identifying and implementing process improvements, and authoring regulatory documents in support of the product lifecycle works with a multi-functional group of engineers and scientists through the process development cycle at client to ensure our process requirements and knowledge are suitable for its intended phase of technology transfer: process introduction, clinical manufacturing, validation and commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturing operations meet process requirements, where necessary work with the sites(s) to introduce processes that deliver meaningful therapeutics for our patients.
Top Must Have Skill Sets:
• Academic background in Chemical Engineering with strong knowledge in engineering principles and/or organic chemistry with basic understanding of cGMP/GLP requirements.
• Knowledge of analytical techniques and solid-state characterization and familiarity with statistical analysis and working knowledge of standard plant operations and safety practices
• Excellent project management skills, Strong verbal communication and presentation skills
• Willing to be hybrid as needed.
Day to Day Responsibilities:
• Critically evaluate new processes for identification of process improvements and requirements necessary to prepare processes for scale up and tech transfer.
• Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
• Analyze and document the economic value of existing, proposed process solutions and new process concepts.
• Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
• Routinely monitor manufacturing processes for performance indicators and operations.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.
• Author, review and/or approve of process documentation needed for process validation and commercialization.
• Provide support to commercial projects to support supply demand, ensure highest quality standards and guarantee patient safety.
• Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis, unit operations and life cycle phase of commercial products.
Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Why is the Position Open?
Backfill
Interview Process:
Phone Screen followed by Phone interview
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Location: Cambridge, MA. 02138
Business Unit: DST Synthetics B
Employment Type: Contract
Duration: 2 year with likely extensions and/or conversion to a permanent position.
Rate: $30 - $35/hour W2
Posting Date: 02/25/2025.
Notes: Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
As the DST representative you will be responsible to collaborate with the product delivery team(s) to work with the manufacturing organization(s) to ensure drug substance supply and resolve challenges, identifying and implementing process improvements, and authoring regulatory documents in support of the product lifecycle works with a multi-functional group of engineers and scientists through the process development cycle at client to ensure our process requirements and knowledge are suitable for its intended phase of technology transfer: process introduction, clinical manufacturing, validation and commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturing operations meet process requirements, where necessary work with the sites(s) to introduce processes that deliver meaningful therapeutics for our patients.
Top Must Have Skill Sets:
• Academic background in Chemical Engineering with strong knowledge in engineering principles and/or organic chemistry with basic understanding of cGMP/GLP requirements.
• Knowledge of analytical techniques and solid-state characterization and familiarity with statistical analysis and working knowledge of standard plant operations and safety practices
• Excellent project management skills, Strong verbal communication and presentation skills
• Willing to be hybrid as needed.
Day to Day Responsibilities:
• Critically evaluate new processes for identification of process improvements and requirements necessary to prepare processes for scale up and tech transfer.
• Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
• Analyze and document the economic value of existing, proposed process solutions and new process concepts.
• Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
• Routinely monitor manufacturing processes for performance indicators and operations.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.
• Author, review and/or approve of process documentation needed for process validation and commercialization.
• Provide support to commercial projects to support supply demand, ensure highest quality standards and guarantee patient safety.
• Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis, unit operations and life cycle phase of commercial products.
Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Why is the Position Open?
Backfill
Interview Process:
Phone Screen followed by Phone interview
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Salary : $30 - $35
