Connie Holen Connie Holen

QC Manager - Animal Health

We are a growing animal health company that specializes in the manufacture of biologics and nutrition solutions.  Our product portfolio is expanding and we are looking for an experienced QC Manager who is technically strong with QC assays related to in process and final testing of viral, parasitic and bacterin based products.

Lincoln, Nebraska

We are a growing animal health company that specializes in the manufacture of biologics and nutrition solutions.  Our product portfolio is expanding and we are looking for an experienced QC Manager who is technically strong with QC assays related to in process and final testing of viral, parasitic and bacterin based products.

The successful candidate will have a strong background in microbiology, quality testing methods for animal or human pharmaceutical products, and experience working in a USDA or FDA regulated environment.  This person has been a key player in the successful license of veterinary vaccines.  They are strategic, good at listening to and implementing new ways of doing things and constantly tuned in to process improvement.

Located in Lincoln, Nebraska, we offer the opportunity to make every day a success story and put your mark on our company!  Someone that enjoys working cross-functionally with multiple departments, agencies and business partners will thrive in this role.

We offer excellent benefits, salary in the range of $90k to $120k plus substantial bonus!

Responsibilities:

  • Coordinate and oversee in-process and final product testing of vaccines including, but not limited to, virus titration, bacterial enumeration, or sterility testing.

  • Understand, troubleshoot and optimize advanced biological lab techniques.

  • Direct activities related to qualification of new assay controls and instrumentation (flow cytometers, auto-titrators and others as we expand).

  • Stay up to date with USDA-CVB guidelines, Veterinary Service memo’s, 9CFR policies and other relevant documentation as needed.

  • Oversee tech transfer activities related to QC.

  • Work closely with team members and business partners to meet quality deadlines to license new products.

  • Implement new QMS or enhance existing electronic records system.

  • Serve as a sounding board to bring in new ways of thinking, new ways of doing things to continuously improve efficiencies.

  • Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control.

 Requirements:

  • 1 to 2 years of supervisory/managerial experience

  • Bachelor’s degree in Microbiology, Biology, immunology or related field with 8 years of technical experience in pharma, USDA or related industry

  • OR Master’s degree or higher with 4 years of technical experience in pharma, USDA or related industry

  • Experience working in a USDA or FDA regulated environment

  • Experience with guidance documents pertaining to veterinary biologics preferred

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Connie Holen Connie Holen

Quality Control Analyst

We are seeking a QC Analyst to join our team.  If you are passionate about making a difference in a fast paced, entrepreneurial environment, this is the perfect opportunity for you.  Each day will bring new responsibility and career-growth opportunities.

Manhattan, Kansas

About the Company

We are a fast-growing biotech that specializes in the development, manufacture and sale of recombinant proteins.  Our mission is to empower scientists and biomanufacturers by providing sustainable and scalable technologies for cell & gene therapies, vaccines and other biological products.  Based near Manhattan, Kansas, our growing portfolio of products are sold around the world!

About the Role

We are seeking a QC Analyst to join our team.  If you are passionate about making a difference in a fast paced, entrepreneurial environment, this is the perfect opportunity for you.  Each day will bring new responsibility and career-growth opportunities.

Responsibilities

  • Conduct routine analysis of raw materials, in-process samples, and finished product following SOPs to ensure compliance with established specifications.

  • Perform testing as requested including, but not limited to HPLC, ELISA, UV-VIS, endotoxin determination and gel electrophoresis.

  • Identify opportunities for improvement and contribute to the implementation of best practices within the Quality department.

  • Draft new or update existing SOPs to reflect changes in processes or regulations.

  • Collaborate with the Process Development, Cell Culture and Quality teams to assist in the development and validation of new analytical methods.

  • Investigate and resolve quality-related issues and product non-conformances.

  • Assist in the design, development and implementation of a custom Laboratory Information Management System (LIMS).

Qualifications

  • BA/BS in biology, microbiology, biochemistry or related field.  Will consider no degree with 2-3 years of relevant experience.

  • Prefer experience with our testing methods and working under ISO quality standards or FDA regulated environment.

Pay range and compensation package

Salary range $50k to $60k with flexibility for well qualified candidates PLUS excellent benefits including   tuition reimbursement.

Take the next step in your career and join our team to solve industry-wide challenges through the power of our technology!

Apply

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