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Engineer - E2E Pivotal Drug Substance Development

Engineer - E2E Pivotal Drug Substance Development

3 Key ConsultingCambridge, MA, United States
7 days ago
Job type
  • Permanent
Job description

Job Title : Engineer - E2E Pivotal Drug Substance Development (JP13969)

Location : Cambridge, CA. 02138

Employment Type : Contract

Business Unit : AMA Pilot Plant

Duration : 1+ years (with likely extensions and / or conversion to permanent)

Rate : $36 - $41 / hour

Posting Date : 04 / 19 / 25

Notes : Only qualified LOCAL candidates need apply. Must have lab or relevant industry experience and at least one year working on similar projects

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description :

  • The candidate must have lab or relevant industry experience and at least one year working on similar projects
  • Ideal Candidate : B.S. graduate with some work experience. Around 1+ YOE is ideal.

Nice to have : Maintenance background; hands-on experience with equipment support and troubleshooting.

The Pivotal Drug Substance Technologies organization at our client is seeking a skilled Engineer to join their team. This lab-based position that involves developing, characterizing, and supporting clinical drug substance manufacturing processes for late-stage programs in their product portfolio. The Pivotal Drug Substance Technologies organization at our client develops, characterizes and supports clinical drug substance manufacturing processes for all late-stage programs in their product portfolio.

This lab-based position is located at our Cambridge, MA site. The successful candidate will be responsible for the development, characterization and scale-up of upstream and downstream processes to enable clinical advancement of programs. The candidate will also be responsible for equipment maintenance and reliability. This role will include project-based work managed by the candidate.

This role is in an integrated bioprocess development group in which cell culture and purification scientists work together to advance client's rich, exciting and dynamic pipeline. With their approach, the position provides the unique opportunity to work on multiple modalities including antibodies, BiTEs, and bispecifics.

The successful candidate will design and execute experiments spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to laboratory operations, technology development, and process automation. Finally, the candidate will also expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.

Top Must Have Skills :

  • Organized project work
  • Proactive troubleshooting
  • Collaborative project experience
  • Asset management experience

    • Day to Day Responsibilities :

  • Ensure preventative maintenance is performed on equipment
  • Coordinate and organize project work
  • Support continuous improvement projects
  • Cell Culture and Bioreactor Management : Culturing mammalian cells, maintaining bench-scale bioreactors, and sampling bioreactors.
  • Process Analytical Technologies (PAT) : Utilizing PAT for process monitoring, optimization, and control.
  • Data Analysis : Compiling and analyzing experimental data to support process development and optimization.
  • Equipment Maintenance : Ensuring equipment reliability and performing routine maintenance.
  • Project Management : Managing project-based work and collaborating with cross-functional teams.
  • Experiment Design and Execution : Designing and executing experiments spanning cell culture and purification operations, applying established platform approaches, and solving day-to-day experimental challenges.
  • Innovation and Technology Development : Contributing to laboratory operations, technology development, and process automation through innovative thinking.

    • Basic Qualifications :

    Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

    Preferred Qualifications :

  • Master's degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence.
  • Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment.
  • Prior experience with high throughput systems (such as the AMBR) or PAT.
  • Prior experience with project management.
  • Motivated self-starter with excellent interpersonal and organizational skills. Team player with the ability to successfully work within a diverse team in a dynamic, cross-functional environment.
  • Familiarity with design of experiments and statistical analysis of data desirable.
  • Prior experience with data analytical tools (Excel, Spotfire, Python etc.)

    • Red Flags :

  • Low GPA. Non-scientific major / experience.
  • Candidates must be willing to grow and develop.
  • Job hopping.

    • Interview process :

    MS teams screen followed by in-person panel interviews.

    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.

    Regards,

    3KC Talent Acquisition Team

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    Development Engineer • Cambridge, MA, United States