About Immunis:
Immunis is a clinical-stage private biotechnology company researching and developing stem cell derived secretome products targeting age-related disease, tissue repair, and regeneration. Immunis’ current focus is the advancement and development of its current clinical stage asset, IMM01-STEM, which is currently being investigated for its therapeutic impact on muscle.
Our investigational product, IMM01-STEM is multi-active biologic derived from the stem cell secretome. It contains a variety of imuno-modulators, growth factors and pro-regenerative factors and proteins that have demonstrated efficacy mouse models of disuse atrophy and diet induced obesity. .
Immunis is at the forefront of innovative research and promotes an exciting and unique ground-floor experience with an opportunity for career advancement in the biotechnology industry. We are seeking a highly motivated, experienced, and detail-oriented Development Scientist to join our team.
Job Summary:
As a Development Scientist at Immunis, you will primarily be responsible for the design and overseeing work with developing our product pipeline in addition to scale-up development. As a small company, you will work closely with cross-functional teams, including the Quality and Manufacturing departments.
The ideal candidate possesses an excellent attention to detail, is willing and eager to quickly adapt, has a strong technical background in proteomics and the manufacture of recombinant proteins, and is looking to grow within the biotech/biopharma industry. The position is immediately available.
Responsibilities:
- Support the design, writing, and execution of study protocols to quantify, characterize and understand the protein composition of a complex secretome product as well as other research and development initiatives.
- Prepare study reports and contribute to scientific writing, including investigator brochures, CMC modules for IND applications, patents, and other regulatory or technical documents.
- Oversee Contract Research Organizations completing studies on Immunis’ behalf
- Complete training, and remain up to date, on SOPs to ensure precision in routine responsibilities.
- Confidently operate laboratory equipment relevant to company procedures.
- Prepare and maintain accurate and comprehensive documentation of all performed activities including, but not limited to, procedures, data, and results, including laboratory notebooks, electronic records, and reports.
- Contribute to the training and competency of team members, ensuring a culture of quality, safety, and compliance throughout the organization.
- Perform responsibilities in compliance with standards outlined by Immunis’ Quality Management System (QMS) to meet regulatory requirements, including but not limited to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
- Work to identification of gaps in the current product characterization, manufacturing, compliance with GMP and scalability, and the activities to address these gaps, such as designing and executing the required projects
- Continuous Improvement: Collaborate with cross-functional teams to identify areas for process improvement and participate in the implementation of initiatives to enhance operational efficiency, and product quality.
Qualifications:
- Education and experience: bachelor’s degree with a strong understanding of and at least 5 years of comprehensive hands-on laboratory experience in protein characterization, quantification and recombinant protein manufacturing.
- Master's degree with two years of experience in quality control, manufacturing or development of recombinant protein products.
- PhD in a related field with a focus on protein biology, biochemistry, molecular biology or chemistry.
- Experience with routine laboratory procedures such as western blotting, protein purification and quantification, ELISAs, mass-spectrometry and other procedures involved in the generation characterization and identification of proteins.
- Strong trouble shooting skills and the ability to adapt techniques and assays to answer challenging questions.
- Excellent analytical and problem-solving skills, with a meticulous attention to detail and accuracy
- Strong written and verbal communication skills, with the ability to effectively collaborate and communicate across departments.
- Adaptable to a fast-paced, small-company environment
- Ability to work independently and prioritize tasks
- A strong commitment to quality, safety, and compliance
- Proficient in Microsoft Office Suite, with an emphasis on Word and Excel
- Legally authorized to work in the USA
The following skills and experiences are beneficial, but NOT required for consideration
- Experience working within aseptic conditions
- Experience with tangential flow filtration (TFF)
- Experience with the culture of mammalian cells including iPSCs.
- Experience with technical writing such as study reports or regulatory documents.
- Knowledge of analytical techniques and instruments commonly used in the biotechnology industry
- Familiarity with GMP regulations, FDA guidelines, and ISO 9001 standards
- Experience with electronic document management and document control
