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We believe we can make a difference, transform cancer medicine, and bring hope to patients and their loved ones. We know this starts with a great team that embraces excellent science, fosters creativity, and is passionate about advancing our dreams.
Process Development and Manufacturing Scientist/Engineer
Quiet Therapeutics – Lexington, MA
Quiet Therapeutics, Inc. is seeking a talented Process Development Scientist/Engineer to help lead scale-up and technology transfer to CMOs. In this position you will be instrumental to translating Quiet’s novel nanoparticle formulations and manufacturing technology to clinical production.
Essential duties include the design and performance of process development studies defining optimal manufacturing parameters, critical operating conditions, and in-process controls. You will create in-house batch records and systems for controlling critical raw materials and managing the supply chain. You will also lead the transfer of drug product production methods to CMOs for scale-up, validation, and support of clinical-stage programs and will help manage the drug substance supply vendors. Strong technical, organizational, and communication skills, as well as the ability to develop creative solutions to challenging problems, are required. Over time you will help develop a process development and manufacturing team to advance Quiet’s technology through the clinic and beyond.
- Define the specific equipment and systems to translate the formulation process into a CMO-ready production package
- Determine critical operating parameters and their ranges for robust manufacture of product at scale
- Develop scaling-rules for translating production to higher volumes through the clinical stages
- Work in a hands-on, dynamic laboratory and set standards for process development operations
- Write, review, and edit of standard operating procedures
- Perform data analysis, distribute and communicate findings, and create records of high quality for intellectual property and consistent with good scientific practices
- Oversee successful establishment of cGMP processes for the production of GAGomers at CMOs
- Provide leadership in the development of specifications for pre-clinical programs
- Assist in the preparation of regulatory filings for clinical-stage programs
- MS or PhD. in chemical engineering or related physical sciences with 3-7 years of relevant industry experience
- Experience with aseptic manufacturing processes, microfluidics, and lyophilization strongly preferred
- Strong command of cGMP principles and practices
- Familiarity with nanoparticulate drug products, lipids and oligonucleotides a bonus
- Demonstrated ability to work in a team environment and manage external vendor operations
Quiet Therapeutics is an equal opportunity employer.
Job Type: Full-time