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; handson 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 labbased position that involves developing characterizing and supporting clinical drug substance manufacturing processes for latestage 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 latestage programs in their product portfolio.
This labbased position is located at our Cambridge MA site. The successful candidate will be responsible for the development characterization and scaleup 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 projectbased 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 clients 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 endtoend drug substance process including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problemsolving skills to rapidly solve daytoday experimental challenges. Additionally the candidate will utilize outofthebox 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 benchscale 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 projectbased work and collaborating with crossfunctional teams.
Experiment Design and : Designing and executing experiments spanning cell culture and purification operations applying established platform approaches and solving daytoday 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:
Masters 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 selfstarter with excellent interpersonal and organizational skills. Team player with the ability to successfully work within a diverse team in a dynamic crossfunctional 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. Nonscientific major / experience.
Candidates must be willing to grow and develop.
Job hopping.
Interview process: MS teams screen followed by inperson panel interviews.
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