Job Title: Engineer, Synthetics/Small Molecule Processes (JP13329) Location: Cambridge, MA. 02138 Business Unit: DTS Synthetics Employment Type: Contract Duration: 2+ years with likely extensions and/or conversion to a permanent position. Rate: $38 - $42/hour W2 Posting Date: 10/29/2024. Notes: Only qualified candidates need apply. **This is a 100% onsite position. Local candidates to Cambridge, MA only**
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:
We are looking for a proactive individual contributor who excels in teamwork, problem-solving and critical thinking.
Candidate must have experience in synthetics/small molecule processes.
We would like experience working in a kilo lab or small molecule manufacturing (preferable, but not a must have, this can be trained once the EW is in the role).
In this role, you will be responsible for supporting the process development and technical transfer of client’s synthetic drug substance processes by first demonstrating scale-up execution in the kilo lab. This role also requires acting as an equipment and instrument owner, and leading inventory maintenance and chemical/equipment ordering and shipping. The Scale-up Lab (SUL) is integral to the optimization, scale-up, and technology transfer of client’s drug substance intermediates and final API. This enabling capability within the DSTS organization critically supports programs across all stages of development, including route selection, process optimization, and process characterization.
Top Must Have Skill Sets:
Experience working in a chemical synthesis lab
Individual contributor, able to perform tasks with minimal to no supervision
Good communication skills
Synthetics/small molecule processes
This role also requires acting as an equipment and instrument owner, and leading inventory maintenance and chemical/equipment ordering and shipping.
Day to Day Responsibilities: Lead operations in the Scale-Up Lab (SUL):
Act as a superuser of all SUL equipment and accessories.
Provide on-the-floor support to ensure successful scale up and rapid problem solving and decision making.
Enable safe execution of SUL operations with minimal to no supervision.
Work closely with process development chemists and engineers to generate and interpret data, providing improved understanding and guidance for synthetic (small molecule) drug substances.
Executions of bench/kilo laboratory experimentation and process modeling/simulation to design and optimize robust synthetic processes.
Provide hands-on troubleshooting support related to processing and process equipment problems
Represent the organization within a multi-functional team to ensure deliverables are aligned with the timeline, ensuring key achievements are established and met.
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
Author, review, and/or approve process documentation, master batch records, operational SOPs, and safety protocols needed to support SUL.
Order and maintian non-GMP chemical storage within SUL
Update compound and material inventory for projects to demonstrate in AMA SUL in coordination with step lead
Documentation of Real-Time Execution and Verification of Processing Steps in the Batch Sheet Instructions
Equipment upkeep and maintenance:
Coordinate equipment scheduling for new experiment requests.
Submit work orders, independently manage equipment maintenance, and support equipment troubleshooting.
Support preventative maintenance operations related to lab equipment and utilities, including, but not limited to, reactors, filters, rupture discs, heat transfer unit and chiller equipment.
Lead lab inventory management, including monitoring usage, ordering, and restocking of consumables.
Establish a management system for equipment replacement parts and maintain stock.
Demonstrate expertise with lab equipment handling and repair to troubleshoot challenges.
Execute Installation Operational Verification (IOV) and Evaluate Performance and Reliability of New Equipment
Lab improvements and knowledge management:
Support efforts for lab upgrades and optimization.
Assist in authoring training documentation for lab operations and equipment.
Monitor training compliance and coordinate training refreshers through the client’s training system.
Participate in and curate content for core and steering team meetings.
Participate in EHSS risk assessments and periodic reviews, acting as an SME.
Coordinate mitigations resulting from RAs and reviews.
Provide hands-on training and oversight for new users and refresher training for previous users.
Basic Qualifications:
Bachelor’s in chemistry or chemical engineering with at least two years of experience (can be academic or professional in the synthetics/small molecule processes).
High school diploma / GED and 8 years of related Engineering or Operations experience
Associate’s degree and 4 years of related Engineering or Operations experience
Bachelor’s or Master’s degree and 2 years of relatedEngineering or Operations experience
Preferred Qualifications: Experience working in a kilo lab or small molecule manufacturing (preferable, but not a must have, this can be trained once the EW is in the role).
Interview Process: 2 Rounds; phone screen followed by final round either virtual or an onsite interview in Cambridge Office
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.