Dexian
This range is provided by Dexian. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $35.00/hr - $41.00/hr
Duration 12 Months (possibility of extension)
Location Cambridge, MA 02142
Schedule Mon- Fri 9am – 5pm
Pay range $31-$41/hr on W2
Job Description
The Engineer II (MTS) will be a part of the internal Manufacturing Technical Services team; your support of critical activities within our team will help us bring our RNAi technology to patients.
You will be contributing to the DP technology transfer team to ensure robust manufacturing of our commercial drug products.
Key Responsibilities
Support Technology Transfer Activities: Assist in process scale-up, optimization, and technology transfer efforts for new drug product manufacturing at contract manufacturing organizations (CMOs). Participate in due diligence and technical assessments to ensure readiness for transfer.
Manufacturing Support: Help assess deviations, contribute to change control documentation, and support CAPA development and risk assessments related to drug product manufacturing under guidance from senior staff.
Data Analysis and Trending: Participate in routine process data collection and trending activities. Assist in preparing summaries and visualizations for internal reviews and management presentations.
Continuous Improvement: Identify opportunities for process improvements and contribute to implementation plans. Collaborate with cross-functional teams to evaluate regulatory and operational impacts of proposed changes.
Validation and Launch Support: Support the development of process validation protocols and sampling plans. Assist in execution and documentation of validation activities to meet GMP requirements.
Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience
Assist in the execution of development experiments in the lab as needed.
Ensure commercial drug product manufacturing readiness prior to each lot.
Support timely closure of deviations, investigations and CAPAs
Contribute to authoring process control documentation
Communicate updates to key cross functional teams
Contributions to Manufacturing department and company goals and objectives.
Education and Qualifications
B.S. in applicable science field
2+ years of experience in a laboratory setting
Competence with MS Word, Excel, and PowerPoint
Data Trending experience (Excel, JMP) is desirable
Required Skills
Ability to work independently
Excellent team skills, organization, collaborative spirit, and strong communication skills (written and verbal)
Ability to maneuver through changing priorities
Experience or exposure to working in GMP environments is desired
Must be able to adhere to all laboratory safety requirements
Ability to travel between domestic Client sites is helpful (Kendall, Alewife and Norton)
May be required to lift objects up to 50lbs
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Seniority level Mid-Senior level
Employment type Contract
Job function Manufacturing and Strategy/Planning
Industries Pharmaceutical Manufacturing and Biotechnology Research
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Base pay range $35.00/hr - $41.00/hr
Duration 12 Months (possibility of extension)
Location Cambridge, MA 02142
Schedule Mon- Fri 9am – 5pm
Pay range $31-$41/hr on W2
Job Description
The Engineer II (MTS) will be a part of the internal Manufacturing Technical Services team; your support of critical activities within our team will help us bring our RNAi technology to patients.
You will be contributing to the DP technology transfer team to ensure robust manufacturing of our commercial drug products.
Key Responsibilities
Support Technology Transfer Activities: Assist in process scale-up, optimization, and technology transfer efforts for new drug product manufacturing at contract manufacturing organizations (CMOs). Participate in due diligence and technical assessments to ensure readiness for transfer.
Manufacturing Support: Help assess deviations, contribute to change control documentation, and support CAPA development and risk assessments related to drug product manufacturing under guidance from senior staff.
Data Analysis and Trending: Participate in routine process data collection and trending activities. Assist in preparing summaries and visualizations for internal reviews and management presentations.
Continuous Improvement: Identify opportunities for process improvements and contribute to implementation plans. Collaborate with cross-functional teams to evaluate regulatory and operational impacts of proposed changes.
Validation and Launch Support: Support the development of process validation protocols and sampling plans. Assist in execution and documentation of validation activities to meet GMP requirements.
Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience
Assist in the execution of development experiments in the lab as needed.
Ensure commercial drug product manufacturing readiness prior to each lot.
Support timely closure of deviations, investigations and CAPAs
Contribute to authoring process control documentation
Communicate updates to key cross functional teams
Contributions to Manufacturing department and company goals and objectives.
Education and Qualifications
B.S. in applicable science field
2+ years of experience in a laboratory setting
Competence with MS Word, Excel, and PowerPoint
Data Trending experience (Excel, JMP) is desirable
Required Skills
Ability to work independently
Excellent team skills, organization, collaborative spirit, and strong communication skills (written and verbal)
Ability to maneuver through changing priorities
Experience or exposure to working in GMP environments is desired
Must be able to adhere to all laboratory safety requirements
Ability to travel between domestic Client sites is helpful (Kendall, Alewife and Norton)
May be required to lift objects up to 50lbs
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Seniority level Mid-Senior level
Employment type Contract
Job function Manufacturing and Strategy/Planning
Industries Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr