Scientist- Analytical Development

7 days ago

Skokie, United States The Steely Group Full time

Our client is seeking a dynamic and experienced Scientist to join its Analytical Development team. In this role, you will be responsible for the development and qualification of analytical methods for peptide and recombinant drug substances as well as nanoparticle drug products. You will play a crucial role in ensuring the quality, safety, and efficacy of our pharmaceutical products while supporting the development of innovative drugs.


Key Responsibilities:

Performing analytical development activities for the testing and characterization of peptides, recombinant proteins, and nanoparticle based parenteral drug products utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis and a number of other characterization techniques.

  • Development and qualification of analytical methods within cGMP compliance.
  • Designing and conducting stability, impurity, and degradation studies.
  • Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions.
  • Providing subject matter expertise relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
  • Working cross functionally with Process Development, Manufacturing, MSAT, Regulatory, and Quality Assurance departments.
  • Support R&D, GMP characterization, release, and stability testing
  • Author and review technical documentation, including but not limited to, protocols, standard operation procedures (SOP), work instructions, records, and reports
  • Perform peer review of analytical test records
  • Perform routine calibration, maintenance, and operation checks on laboratory equipment
  • Execute and document all work according to policies and procedures
  • Work collaboratively with and support Development Lab



Qualifications:

  • BS+ Degree in Biology, Chemistry, Bioengineering, Chemical Engineering, Biochemistry, or related field.
  • 1+ years of experience in analytical development
  • Recombinant Protein Analytical expertise
  • Parenteral Drug Product Analytical expertise
  • Expertise working with HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis, nanoparticle characterization, microbial methods.
  • Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired.
  • Experience working on method transfer and validation activities within cGMP compliance.
  • Ability to efficiently prioritize, manage, and complete multiple projects in a fast-paced environment.
  • Proficient with a broad spectrum of analytical techniques applicable to particle-based drug delivery systems (e.g. particle size, plate-based assays, SEM, FTIR, mass spectroscopy, HPLC, etc.)
  • Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
  • Must possess effective verbal and written communication skills.

  • Scientist- Analytical Development

    7 days ago

    Skokie, United States The Steely Group Full time

    Our client is seeking a dynamic and experienced Scientist to join its Analytical Development team. In this role, you will be responsible for the development and qualification of analytical methods for peptide and recombinant drug substances as well as nanoparticle drug products. You will play a crucial role in ensuring the quality, safety, and efficacy of...

  • R&D Analytics Manager

    5 days ago

    Skokie, United States lanzatech Full time

    Supports and empowers the LanzaTech R&D Analytical Chemistry Group: Oversees and directs a diverse team of >10 chemists, encompassing professionals with Bachelor’s, Master’s, and Doctoral degrees, ensuring high-level expertise and experience in the field. Works closely with scientists to understand project requirements and delivers timely solutions to...

  • Data Analytics Analyst II

    4 weeks ago

    Skokie, United States NorthShore PC Service Full time

    Position Highlights: Position: Data Analytics Analyst II Location: 4901 Searle Parkway, Skokie IL - hybrid setting Full Time Hours: Monday-Friday, 8am - 4:30pm Are you inspired by an opportunity to make significant change in the lives of patients in your community, support busy medical providers through technology innovation, and influence the quality of...

  • Senior Research Scientist- Molecular Biology

    4 weeks ago

    Skokie, United States Charles River Laboratories Full time

    Senior Research Scientist- Molecular Biology Req ID #: 221875 Location: Skokie, IL, US, 60077 For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe....

  • Senior Research Scientist- Molecular Biology

    4 weeks ago

    Skokie, United States Charles River Laboratories Full time

    Senior Research Scientist- Molecular Biology Req ID #: 221875 Location: Skokie, IL, US, 60077 For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe....

  • VCB I Business Insights and Analytics Manager

    4 weeks ago

    Skokie, United States Visual Comfort Full time

    Position Summary: The Manager will join the Finance & Strategic Analytics Team and will lead the development and execution of our enterprise reporting, analytics, and process automation strategy. Responsibilities: Partner with Enterprise Data Management team on data quality and data field development initiatives. Define and execute enterprise Power BI...

  • VCB I Business Insights and Analytics Manager

    2 weeks ago

    Skokie, Illinois, United States Visual Comfort Full time

    Position Summary: The Manager will join the Finance & Strategic Analytics Team and will lead the development and execution of our enterprise reporting, analytics, and process automation strategy. Responsibilities: Partner with Enterprise Data Management team on data quality and data field development initiatives. Define and execute enterprise Power BI...

  • Senior Research Scientist- Molecular Biology

    1 month ago

    Skokie, Illinois, United States Charles River Laboratories, Inc. Full time

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • Senior Research Scientist- Molecular Biology

    2 weeks ago

    Skokie, Illinois, United States Charles River Laboratories, Inc. Full time

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • SNOW Developer

    2 weeks ago

    Skokie, Illinois, United States S2ssoft Full time

    Job DescriptionHey there!We have an awesome opportunity for a SNOW Developer in Skokie, IL (Onsite). If you have more than 10 years of experience, keep on reading!Roles and Responsibilities:Support Enterprise Architecture in automating discovery & data federation into the ServiceNow CMDB.Develop technical solutions on the ServiceNow platform aligned with...

  • Product Development Specialist

    3 weeks ago

    Skokie, United States HIKINEX Full time

    SUMMARY The position of Product Development Specialist is involved in the creation and refinement of new food products, ensuring they meet quality, safety, and nutritional standards as directed by the Product Development Supervisor and working with production personnel in the commercialization of new products as they transition to production.   PRIMARY...

  • Product Development Specialist

    2 weeks ago

    Skokie, United States Agility Personnel Full time

    Job DescriptionJob Description SUMMARYThe position of Product Development Specialist is involved in the creation and refinement of new food products, ensuring they meet quality, safety, and nutritional standards as directed by the Product Development Supervisor and working with production personnel in the commercialization of new products as they transition...

  • Snow Developer

    4 weeks ago

    Skokie, United States PV Group Inc Full time

    **Job Responsibility**: - Support Enterprise Architecture in the design and implementation of automated discovery & data federation from multiple data sources into the ServiceNow CMDB. - Develop technical solutions on the ServiceNow platform, ensuring that they meet the client's needs and are aligned with ITIL, ITSM, ITOM and CMDB best practices. - Lead...

  • Servicenow Developer

    4 weeks ago

    Skokie, United States Ehub global solution Full time

    **Roles and Responsibilities: - ** **Support Enterprise Architecture in the design and implementation of automated discovery & data federation from multiple data sources into the ServiceNow CMDB.** **Develop technical solutions on the ServiceNow platform, ensuring that they meet the client's needs and are aligned with ITIL, ITSM, ITOM and CMDB best...

  • ServiceNow Developer

    2 weeks ago

    Skokie, United States Vakulatech Full time

    Job DescriptionJob DescriptionJob Title: ServiceNow DeveloperLocation: Skokie, IL (Day 1 Onsite)Contract: W2 Min 10 +yrs of Experience required Active Certificate MandotoryAreas Of SupportPrimary areas of support include: NOW Core Platform Security, CMDB, Discovery ITOM Discovery, Service Mapping, Event Management, Cloud Management SAM Software Asset...

  • ServiceNow Developer

    1 month ago

    Skokie, United States Omni Inclusive Full time

    Roles and Responsibilities:- Support Enterprise Architecture in the design and implementation of automated discovery & data federation from multiple data sources into the ServiceNow CMDB. Develop technical solutions on the ServiceNow platform, ensuring that they meet the client's needs and are aligned with ITIL, ITSM, ITOM and CMDB best practices. ...

  • SNOW Developer

    2 weeks ago

    Skokie, United States S2ssoft Full time

    Job DescriptionJob DescriptionHiKindly have a look on the below job description, and let me know your interest with expected pay rate and work visaJob Title: SNOW DeveloperLocation: Skokie, IL (Onsite)Mode : Contract Min 12 +yrs of Experience requiredRoles and Responsibilities: -Support Enterprise Architecture in the design and implementation of automated...

  • SNOW Developer

    2 weeks ago

    Skokie, United States Themesoft Inc. Full time

    Job Title: SNOW DeveloperLocation: Skokie, ILMode : Contract (6+ Months) (Day 1 Onsite) Rate - $50/hr on W2 or $60/hr on C2CMin 12 +yrs of Experience requiredRoles and Responsibilities:-⦁ Support Enterprise Architecture in the design and implementation of automated discovery & data federation from multiple data sources into the ServiceNow CMDB.⦁ Develop...

  • Corporate Development

    2 weeks ago

    Skokie, Illinois, United States lanzatech Full time

    Welcome to the Post Pollution Future with LanzaTechAbout the Company:LanzaTech was established with the belief that there is an abundance of carbon available above ground to fulfill all our needs. Our biorecycling technology converts carbon into sustainable raw materials, eliminating the necessity for fresh fossil carbon in various products and transport...

  • Application Development Manager

    2 weeks ago

    Skokie, Illinois, United States Responsive Search Inc Full time

    iSeries Manager of Application Development Responsibilities include:Managing the IT Development staff and contractors – currently consists of 4 resourcesDesign, development and delivery of quality business applicationsLeading the approach and design of partner integrationsUsing technical and functional expertise to be a lead architect in designing...