Manufacturing Scientist - Chromatography
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Role Summary
Manufacturing Scientist - Chromatography position within Cliniqa, a Bio-Techne brand, focused on developing or optimizing procedures for small- and large-scale processes. Leads product initiatives to enable novel products through integration of reagents, instrumentation, analysis algorithms and software. Supports all stages of manufacturing, including prototype optimization, guard-banding, design lock, verification, validation, and design transfer. Leads key project deliverables and contributes to design control and technical risk analysis, independently designing and analyzing complex experiments and large data sets to inform design decisions and risk mitigation.
Responsibilities
- Independently design and carry out experiments leading to the development/optimization of key biological intermediates and purifications.
- Gain understanding of purification methods and support design and characterization of novel methods.
- Apply/learn new characterization methods for detection or quantification of multimodal biomarkers from clinical specimens or in process reagent qualification.
- Lead the creation of protocols, SOPs, 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 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 and communicating effectively within teams and cross-functionally.
- Organize, analyze, and/or visualize complex datasets using analytical software (JMP, R, or Python) and communicate results clearly to technical and non-technical audiences.
- Lead and contribute to design and execution of experimental plans or processes to support organizational objectives.
- Apply scientific methods and process design principles to improve product development and manufacturing processes.
Qualifications
- Required: PhD in Chemistry, biomedical engineering, or related field, or Master’s degree with 6-8 years of relevant industry experience; Bachelor’s with 10+ years acceptable.
- Strong chromatography knowledge.
- Experience developing and validating/verifying purification procedures under design control using a requirements-driven, risk-based approach in biotech or clinical labs.
- Strong track record of independence, productivity, and creative problem-solving.
- Expertise in one or more technical areas and as a resource to develop skills in colleagues.
- Ability to independently design and implement experimental plans, including optimization and guard banding of product prototypes.
- Excellent written and verbal communication skills and attention to detail.
- Passion for improving patient care through diagnostic technologies.
Preferred
- Proficiency with Excel, JMP, Python and/or R.
- Experience with establishing DOE protocols and data interpretation.
- Familiarity with standards/guidelines for validating critical procedures.
- Ability to contribute to early-stage product prototype development.
- Ability to apply statistical analysis to large data sets, especially with code.