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Manufacturing Engineer
Confidential • Watertown, MA 02472 • Posted 2 days ago via LinkedIn
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In-person • Full-time • Junior Level
Job Highlights
Using AI ⚡ to summarize the original job post
The Manufacturing Engineer at Confidential will perform hands-on manipulations of the aseptic manufacturing process, working with primary human cells for implantable products. This role involves supporting the improvement of documentation and manufacturability, collaborating on tech transfer activities, and producing implantable products for various studies under cGMP conditions. The position requires a blend of engineering and scientific skills, with a focus on cell or gene therapy experience.
Responsibilities
- Perform direct, hands-on manipulations of the aseptic manufacturing process, working with primary human cells, expansion, cell formulation, encapsulation, and cryopreservation to create implantable products.
- Provide on-going support for the improvement of documentation and manufacturability of the process.
- Collaborate with process development to perform tech transfer activities.
- Perform the daily tasks necessary to produce implantable products for nonclinical pharmacology studies, process development, tech transfer, and under cGMP conditions.
- Support the development of SOPs, batch records, reports, materials management, etc.
- Involvement in isolation of primary cell types to support ongoing GMP manufacturing.
Qualifications
Required
- Bachelor’s degree in engineering or sciences with 2-4 years industry experience, or Master’s degree with 1-2 years of industry experience.
- 1-2 years of cell or gene therapy experience required.
- At minimum, working knowledge of cell or gene therapy manufacturing or operations.
- Understanding or experience of primary cell isolation techniques is a plus.
- Good understanding of processes, documentation, and quality expectations for cGMP manufacturing environment.
- Experience in cell culture principles and cell processing with solid aseptic technique.
- Working experience with basic knowledge of cell biology, cell culture, scale up, bioreactor operation, is preferred.
- Ability to work a flexible schedule that may include weekends and/or holidays.
- Proven ability to work effectively as a member of a multidisciplinary team with an emphasis on written on written and verbal communication, documentation, and attention to detail.
- The successful candidate will have a strong work ethic, be able to generate high-quality work, and enjoy working in a fast-paced team environment.
About Confidential
Manchester Confidential is a reputable brand providing independent reporting on food, drink, news, lifestyle, and events in Manchester. They offer comprehensive coverage and valuable insights through their website, keeping readers informed and helping them make informed decisions about dining spots, events, news, and cultural attractions in the city.
Full Job Description
Responsibilities:
- Perform direct, hands-on manipulations of the aseptic manufacturing process, working with primary human cells, expansion, cell formulation, encapsulation, and cryopreservation to create implantable
- Provide on-going support for the improvement of documentation and manufacturability of the process.
- Collaborate with process development to perform tech transfer activities.
- Perform the daily tasks necessary to produce implantable products for nonclinical pharmacology studies, process development, tech transfer, and under cGMP conditions.
- Support the development of SOPs, batch records, reports, materials management, etc.
- Involvement in isolation of primary cell types to support ongoing GMP manufacturing.
Qualifications:
- Bachelor’s degree in engineering or sciences with 2-4 years industry experience, or Master’s degree with 1-2 years of industry experience.
- 1-2 years of cell or gene therapy experience required.
- At minimum, working knowledge of cell or gene therapy manufacturing or operations.
- Understanding or experience of primary cell isolation techniques is a plus.
- Good understanding of processes, documentation, and quality expectations for cGMP manufacturing environment.
- Experience in cell culture principles and cell processing with solid aseptic technique.
- Working experience with basic knowledge of cell biology, cell culture, scale up, bioreactor operation, is preferred.
- Ability to work a flexible schedule that may include weekends and/or holidays.
- Proven ability to work effectively as a member of a multidisciplinary team with an emphasis on written on written and verbal communication, documentation, and attention to detail.
- The successful candidate will have a strong work ethic, be able to generate high-quality work, and enjoy working in a fast-paced team environment.
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