Overview
Quality Engineer II Jobs in Woonsocket, RI at Honeywell
KaliVir Immunotherapeutics is developing a new generation of optimized, multi-mechanistic cancer immunotherapies, and we are committed to creating a best-in-class immuno-oncology platform to help patients across the globe beat cancer. Our products are primarily cutting-edge viral-based cancer immunotherapies. We are a growing biotechnology startup company based in Pittsburgh, PA.
We are seeking a Process Development & GMP Lab Technician to join our team! In this role, you will work directly with the Process Development and GMP team members to develop and optimize scalable upstream and downstream processes for the manufacture of our lead and pipeline oncolytic virus therapies. This position will allow you to contribute to bringing new, cutting-edge immunotherapies to patients, with an outstanding cross-functional team. The Process Development & GMP Lab Technician will join a small, dedicated team, allowing focused and ambitious individuals to learn new and important skills and advance as our company expands.
Responsibilities:
Work with the Process Development and GMP team to execute project timelines and deliver on process development milestones, accordingly, working with internal departments and external partners.
Support both upstream and downstream process development and provide technical support to project teams
Contribute to process development lab work, including executing experiments with associate scientists and technicians.
Compile, analyze, and present data on a regular basis.
Troubleshoot and resolve any process issues with lead and pipeline products in a timely manner.
Assist with new project strategy and communicate within departments and cross-functionally.
Aid in tech transfer of optimized processes to contract manufacturing facilities and troubleshoot any issues during engineering runs and clinical trial material manufacturing.
Understand the necessity of detailed documentation of all process development work and collaborate with the analytical and QC departments to schedule the analysis of process samples and design new methods of analysis.
Run additional wet lab assays and protocols.
Oversee maintenance of lab equipment
Work in the cleanroom, including sterile gowning, behaving as per cGMP guidelines, cleaning materials and equipment entering the cleanroom, following standard operating procedures, and documenting batch records.
A Successful Candidate:
Is detail-oriented, organized, self-motivated, flexible, and diligent with strong written and verbal communication skills.
Has experience advancing targets from discovery through validation.
Is able to thrive in a fast-paced, high-energy, and team-oriented environment.
Is able to work independently and as part of a team; is capable of building strong internal and external working relationships.
Is able to multi-task, prioritize assignments, and meet deadlines.
Essential Knowledge & Skills
Extremely Proficient in Microsoft Office Suite.
Excellent verbal and written communication skills.
Outstanding time management skills.
Ability to use or learn to use technical laboratory machinery and record data accurately.
Ability to organize work and prioritize tasks in a highly dynamic and cross-functional work environment.
Experience in cell culture and aseptic technique.
Knowledge of current Good Manufacturing Practices (cGMP).
Experience in working in a multi-disciplinary team environment.
Excellent technical and problem-solving skills in the lab, combined with the ability to clearly communicate with team members and supervisors often.
Education and Experience Requirements
B.S. in biology, engineering, or related biomedical science required; M.S. in biology, engineering, or a related biomedical science preferred.
A minimum of two years of relevant industry experience (experience in both upstream and downstream process and CMC development in the pharmaceutical industry) preferred.
Title: Quality Engineer II
Company: Honeywell
Location: Woonsocket, RI
