DescriptionYour Role:
In the
Scientist, Analytical Development role you will have the opportunity to focus on developing cell-based, ELISA, HPLC, and/or CE methods and other analytical techniques to identify and characterize protein biologics. This position offers the chance to interface with project management, Process Development, Quality Control, as well as to interface with external clients. The Scientist will lead testing and sampling to support validation, process development, and stability studies in a non-GMP and GMP environment. Individual will take a product through method development and eventual transfer to a quality control department in a GMP environment. They will have a substantial understanding of the job and apply knowledge and skills to complete a wide range of tasks, as well as support and lead continuous improvement initiatives.
Key Responsibilities:- Develop, perform, troubleshoot and review routine wet chemistry/ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/CE/Maurice) and/or HPLC. May be designated as study lead for validation projects, investigations, and method development projects.
- Must use scientific reasoning when making decisions regarding the quality of the data reported. Expected to research/gather information without supervision and to make scientifically sound decisions based on knowledge and experience.
- Train/supervise the experimental work of more junior analysts. Tabulate and graph data, and prepare technical reports for senior personnel. Review technical data and reports written by less experienced personnel.
- Manage client projects and collaboration with other functional areas including but not limited to MFG, QC, and PM. Provide scientific insights for the joint team to make project decisions.
- Develop, review, revise and write test methods, forms, templates and standard operating procedures and other related documents.
- Actively support the QC department as the Subject Matter Expert (SME).
- Knowledge of company cGMPs as well as industry regulations that apply to job functions. Participate in regulatory inspections.
- Support continuous improvement initiatives.
- Other tasks as assigned.
Minimum Qualifications:
- BS degree in Biochemistry, Chemistry, Biology or a related field is required.
- 8+ years of biotech industry experience working in a QC or analytical lab.
- Previous experience with analytical testing and equipment utilizing analytical biochemistry methods, writing reports/procedures/specifications, GMPs and regulatory audits required.
- HPLC, CE, or Potency/ELISA experience is essential.
- Should have also have experience with protein characterization, electrophoresis, chromatography, and assay validation/qualification.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $109,600 - $137,000 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
