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Colorado State University Biomanufacturing Associate (Production Associate I) - Open Pool in Fort Collins, Colorado

Working Title Biomanufacturing Associate (Production Associate I) - Open Pool

Position Location Fort Collins, CO

Research Professional Position Yes

Posting Number 202000764AP

Position Type Admin Professional/ Research Professional

Classification Title

Number of Vacancies

Work Hours/Week

Proposed Annual Salary Range 30,000-55,000

Employee Benefits

Desired Start Date

Position End Date (if temporary)

To ensure full consideration, applications must be received by 11:59pm (MT) on 03/31/2021

Description of Work Unit

BioMARC is a contract development and manufacturing organization (CDMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CDMO 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 Biomanufacturing Associate (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 • Experience in a microbiology or cell biology type laboratory.

Diversity Statement

Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.

Essential Duties

Special Instructions to Applicants

Please submit a cover letter outlining your specific area(s) of expertise, curriculum vitae and the names and contact information of three professionals references.

References will not be contacted without prior notifications of candidates.

The pool is valid through 3/31/2021. Individuals wishing to be considered beyond this date must reapply.

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

Search Contact Bev Meyer,

EEO Statement

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 or expression, or pregnancy and 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/equal access/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 Acting Title IX Coordinator is the Vice President for Equity, Equal Opportunity, and Title IX, 123 Student Services Building, Fort Collins, CO. 80523, (970) 491-1715.

The Section 504 and ADA Coordinator is the Vice President for Equity, Equal Opportunity, and Title IX, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.

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. 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

Minimum Requested 3

Maximum Requested 3

Supplemental Questions

Required fields are indicated with an asterisk (*).

Applicant Documents

Required Documents

  • Cover Letter

  • Curriculum Vitae

Optional Documents