Manufacturing Scientist - Chromatography

Role Summary

Manufacturing Scientist - Chromatography

Responsibilities

• Independently design and carry out experiments leading to the development/ optimization of key biological intermediates and purifications.
• Gain understanding of various types of purification methods and support design and characterization of novel methods.
• Apply/ learn new characterization methods for the sensitive detection or quantification of multimodal biomarkers from clinical specimens or in process reagent qualification.
• Lead the creation of protocols, presentations, standard operating procedures, design verification and validation procedures, quality control procedures, and technical reports to support lab infrastructure, new product initiatives, and on-market product investigations.
• Contribute to design control and associated documentation for new product initiatives, including drafting of user needs, design inputs/outputs, risk analysis and mitigation, and design transfer.
• Train and mentor co-workers on equipment and procedures and lead data analysis and interpretation.
• Provide substantial, high-quality contributions to projects by working independently, communicating effectively within team and cross-functionally, and leveraging the active support of others.
• Organize, analyze, and/or visualize complex datasets using analytical software (JMP, R, or Python) and statistical comparisons and clearly communicate results or complex scientific topics to technical and non-technical audiences.
• Lead and contribute to design and execution of experimental plans or processes to support objectives within the organization.
• Apply scientific methods and process design principles to improve product development and manufacturing processes.

Qualifications

• Required: A PhD in Chemistry, biomedical engineering, or related field or a Master‚Äôs degree plus 6-8 years of relevant industry experience. Bachelor‚Äôs degree is acceptable with 10+ years of related experience.
• Strong Chromatography knowledge.
• Prior demonstrated experience developing and validating/verifying purification procedures under design control using a requirements-driven, risk-based approach within the biotech industry or clinical laboratory.
• A strong track record of independence, productivity and creative problem-solving.
• Expertise in one or more technical areas and considered a resource by colleagues to develop similar skills.
• Demonstrated ability to independently design and implement experimental plans or processes to support objectives within the organization, including optimization and guard banding of product prototypes.
• Excellent written and verbal communication skills and attention to detail.
• A passion for improving patient care through diagnostic technologies.

Skills

• Proficiency with Excel, JMP, Python and/or R (Preferred).
• Experience with establishing DOE protocols and interpretation of the data (Preferred).
• Familiarity with standards and guidelines for validating critical procedures (Preferred).
• Ability to contribute to early-stage product prototype development where needed (Preferred).
• Ability to apply statistical analysis to large data sets, especially with code (Preferred).