Colorado State University

Description of Work Unit

Founded in 1870, Colorado State University is among the nation’s leading research universities and enrolls approximately 32,000 undergraduate, graduate, and professional students. Located an hour north of the Denver metro area, Fort Collins is a vibrant community of approximately 157,000 residents that offers the convenience of a small town with all the amenities of a large city. Fort Collins is situated on the Front Range of the Rocky Mountains with views of 14,000 foot peaks, and offers access to numerous cultural, recreational, and outdoor opportunities.

CSU BioMARC is a nonprofit contract development and manufacturing organization focused on the production of biopharmaceutical materials for non-clinical, clinical, and commercial use under Biosafety level 2, 3 and Select Agent biosecurity conditions. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and biomanufacturing production scalability.

Position Summary

The Quality Control (QC) Associates are responsible for the implementation and execution of policies and procedures to ensure that quality expectations and standards are met during cGMP biomanufacturing. Individuals will be working within an FDA compatible Quality System using Quality Assurance approved SOPs, protocols and/or similar controlled documents.

Candidates must be able to physically perform complex laboratory techniques including, but not limited to, cell-based assays, environmental monitoring, plate-based assays in rooms that require specialized manufacturing and biocontainment protective gowning and equipment. Entry into and performing tasks under Biosafety level (BSL) 3 laboratory is expected. In addition, work related to assay and analytical method development in support of Non-clinical production/research and process development may be assigned with the expectations that the employee makes use of skills similar to those described above. Successful candidates must be able to perform as part of a team and think critically through instructions, problem solve and make professional judgments about regulatory compliance, quality and continuous improvement paradigms

The different position levels require escalating levels of experience in executing complicated analytical methods in support of the creation and/or processing of biological materials under cGMP conditions.

Required Job Qualifications

Required qualification, rank and salary determined by specific position to be filled.

Minimum Qualifications:

• Level I is for individuals with a Bachelor’s degree in biology, chemistry, or related field OR Bachelor’s degree in an unrelated field plus 1 years of professional experience related to the specific assignment or 1 year experience in a contract manufacturing organization.
• Level II is for individuals with a Bachelor’s degree in biology, chemistry, or related field and 2 or more years of relevant professional experience OR a Master’s degree in biology, chemistry or related field OR Bachelor’s degree in an unrelated field plus 3 years of professional experience in a contract manufacturing organization.

Successful candidate must be legally authorized to work in the United States by time of application; IDRC/BioMARC is not providing visa sponsorship for these positions.

Preferred Job Qualifications

• Relative experience commensurate with the specific position to be filled in an analytical, cell biology, or microbiology type laboratory.
• Relative experience commensurate with the specific position to be filled in a contract manufacturing or other regulated environment.
• Relative experience commensurate with the specific position to be filled e in US code of federal regulation fields of GMP, GLP, and/or GXP.
• Biosafety Level 3/or laboratory work in high containment facility.

EEO

Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity/expression, or pregnancy in its employment, programs, services and activities, and admissions, and, in certain circumstances, marriage to a co-worker. The University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity and equal access institution and affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. The Office of Equal Opportunity is located in 101 Student Services.

The Title IX Coordinator is the Director of the Office of Title IX Programs and Gender Equity, 123 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-1715, titleix@colostate.edu.

The Section 504 and ADA Coordinator is the Director of the Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836, oeo@colostate.edu.

The Coordinator for any other forms of misconduct prohibited by the University’s Policy on Discrimination and Harassment is the Vice President for Equity, Equal Opportunity and Title IX, 101 Student Services Building, Fort Collins, Co. 80523-0160, (970) 491-5836, oeo@colostate.edu.

Any person may report sex discrimination under Title IX to the Office of Civil Rights, Department of Education.