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By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Bio-Techne’s Diagnostic Reagents Division has been providing essential products to the in vitro diagnostics industry for over 40 years. We supply quality controls and reagents for clinical laboratory and point-of-care testing, along with custom products to other companies serving the IVD market.

Position Summary:

The primary responsibilities of the Manufacturing Chemist are to execute formulations, lead technicians to formulate, and perform in-process testing on customer specific formulations using Good Lab Practices and cGMP. In this role you will execute and direct the formulation activities independently, including training and mentoring of junior members of the department. The Formulation Chemist will be responsible for identifying manufacturing issues and effectively communicating those issues to management.

The Manufacturing Chemist will facilitate new product transfers and development of scaled formulations. The Senior Manufacturing Chemist must have the ability to assist in process optimization while maintaining quality and cGMP compliance.

Principle Responsibilities:

• Prepare production equipment for formulation operations per outlined procedures in accordance with SOPs and cGMP.

• Formulate multiple product lines, with the ability to meet the challenges involved with the manufacturing of a biologic formulation. Document chemical and lots used in formulations.

• Perform in process analysis and determine adjustments to bring analytes into specification.

• Write or modify procedures and assist in process optimization to meet department formulation needs and cGMP compliance.

• Perform processing steps including centrifugation, autoclaving, and filtering.

• Perform daily QC calibrations and testing on laboratory instruments and balances.

• Maintain inventory of chemicals and testing supplies and identify shortages or expiring raw materials.

• Work directly with R&D and customers on the transfer of new products into Manufacturing.

• Work with R&D and QC to resolve issues with formulations prior to manufacture.

• Report formulations within ERP system and document control software.

• Use Non-Conforming Material Reports to identify and remove defective material or product from the inventory system.

• Direct and perform laboratory and equipment cleaning.

• Understand and train on safety requirements in working with biologicals and hazardous chemicals.

• Analyze data, draw conclusions and make decisions for next steps on assigned projects.

• Investigate root cause analysis for CAPA’s and complaints.

• Represent the Formulation Team at interdepartmental meetings as required.

• Perform other duties as may be assigned by management.

• Collaborate on projects with a broad scope, high impact or complexity. May lead projects of moderate complexity.

Qualifications

Qualifications:

• BS or BA degree in Biology, Chemistry or related science discipline.

• 5+ years’ experience in biologic formulation and biologic buffers in a GMP environment is desired. Formulation or chemistry experience may substitute for degree if relevant.

• Must have good math skills, manual dexterity and possess a basic mechanical aptitude.

• The ability to work as part of a team, be reliable, multitask, and execute manufacturing goals is required.

• Some extended days and weekend work may be required depending on the current Manufacturing goal.

• Preference for experience in aseptic biologic formulation to help advance new product introductions.

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!

• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.

• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, tuition reimbursement, and more.

• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Bio-Techne is an E-Verify Employer in the United States.