"Alerted.org

Posting Detail Information

Working TitleProduction Associate I

Position LocationFort Collins, CO

Work LocationPosition qualifies for hybrid/in-office work

Research Professional PositionYes

Posting Number202500606AP

Position TypeAdmin Professional/ Research Professional

Classification TitleResearch Associate I

Number of Vacancies

Work Hours/Week40

Proposed Annual Salary Range$50,000 - $70,000

Employee Benefits

Colorado State University is not just a workplace; it’s a thriving community that’s transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact.

+ Review our detailed benefits information here. (https://hr.colostate.edu/wp-content/uploads/sites/25/2021/01/benefits-summary-afap.pdf)

+ Explore the additional perks of working at CSU here.

+ For the total value of CSU benefits in addition to wages, use our compensation calculator (https://hr.colostate.edu/total-compensation-calculator/) .

+ Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in (https://hr.colostate.edu/prospective-employees/our-community/) !

Desired Start Date

Position End Date (if temporary)

To ensure full consideration, applications must be received by 11:59pm (MT) on05/15/2025

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.

The Infectious Disease Research Center ( IDRC ) at the foothills campus of Colorado State University is a unique and lively hub of translational biology that integrates academic research, entrepreneurial companies, and a world-class bio-manufacturing operation unified under one roof. Featuring one of the nation’s most significant infrastructures for working with high consequence pathogens, industry and academic researchers can mingle as they apply cutting edge biotechnology tools to address some of the world’s most pressing health threats. Bio-manufacturing of drugs to be used in clinical trials is performed under FDA regulated conditions within a high containment environment.

BioMARC is a contract manufacturing organization ( CMO ) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CMO owned and operated by CSU ,and was created to translate and produce biopharmaceutical products 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 scalability issues.

Position Summary

The Production Associate I will be responsible for production activities of a cGMP manufacturing campaign under FDA regulations. This job responsibilities require gaining escalating levels of experience in executing complicated batch production records for the creation and/or processing of production materials. Employees will work within an FDA recognized Quality System (or similar) using Quality Assurance approved batch cards, SOPs, protocols and/or the like. Continuous directed and self-directed training in the US Code of Federal Regulation fields of Good Manufacturing Practices ( GMP ), Good Laboratory Practices ( GLP ) and/or Quality Assurance/Control will be expected of each employee. Employees will physically perform complex laboratory techniques in rooms that require specialized manufacturing and biocontainment protective gowning and equipment. Entering a Biosafety level ( BSL ) 2 and/or 3 laboratory is highly likely. Moreover, employees will think critically through instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms. Employees will investigate and report on incidents and provide intelligent corrective proposals. In addition to GMP work, Process Development, Pre-clinical Production and Non-Clinical production/research support may be assigned with the expectations that the employee make use of skills similar to that described above.

Required Job Qualifications

+ Bachelor’s degree in the Sciences or a field related to the responsibilities of the assignment

+ OR Bachelor’s degree in an unrelated field plus at least 2 years of professional experience related to the specific assignment

Preferred Job Qualifications

+ Experience in a contract manufacturing or other regulated environment.

+ Experience in US code of federal regulation fields of GMP , GLP , GXP .

+ Biosafety Level 3 experience/or high containment facility

+ 0-1 year experience in a microbiology or cell biology type laboratory.

Essential Duties

Job Duty CategoryProduction and Documentation Responsibilities

Duty/Responsibility

+ Support the creation of written procedures for biological manufacturing processes, including purification steps and testing methods for production campaigns.

+ Support the creation of controlled documents such as specification sheets, production records, protocols, reports, SOPs and other directive documents.

+ Implement/execute written procedures for biological manufacturing processes, including cell propagation and harvest, purification steps and testing methods for production campaigns with accuracy and reproducibility.

+ Complete documentation requirements for all GMP activities following Good Documentation Practices ( GDP ). Must be able to justify all written records to Regulatory Auditors (e.g., FDA ) in person.

+ Perform both simple and complex laboratory procedures such as bacterial and mammalian cell culture; viral propagation and harvest; UF/DF, TFF and chromatography based purification; and other laboratory processes and methodologies.

+ Support the analysis of complex data sets, summarize findings, and chart corrective actions.

+ Must consistently exercise discretion and judgment to meet production and safety standards in GMP and/or BSL designated environment.

Percentage Of Time80

Job Duty CategoryLaboratory Maintenance Coordination or Laboratory Coordination

Duty/Responsibility

+ Takes responsibility for maintaining material inventories and equipment qualifications for manufacturing use. This includes making the right decisions for types of GMP grade materials and activities needed to generate GMP grade materials.

+ Supports the maintenance of the ISO status as well as the clean room status of each of the GMP room. This involves the physical cleaning of floors, walls, ceilings, equipment and other surface areas in these controlled rooms.

+ Identify training deficiencies, provide recommendations for training and where applicable provide training.

+ Perform laboratory activities in a timely, efficient and concise manner.

+ Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP .

+ Perform other duties as required.

Percentage Of Time20

Application Details

Special Instructions to Applicants

To apply, please upload a cover letter that addresses the required and preferred job qualifications, a resume, and the contact information for three professional references.

CSU is committed to full inclusion of qualified individuals. If you are needing assistance or accommodations with the search process, please reach out to the listed search contact.

References will not be contacted without prior notification to candidates. Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.

Conditions of EmploymentPre-employment Criminal Background Check (required for new hires)

Search ContactDarragh Heaslip, [email protected]

EEO

Colorado State University ( CSU ) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Background Check Policy Statement

Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.

References Requested

References Requested

Minimum Requested3

Maximum Requested3

Supplemental Questions

Required fields are indicated with an asterisk (*).

Applicant Documents

Required Documents

+ Cover Letter

+ Resume

Optional Documents