|Working Title||Production Associate I|
|Position Location||Fort Collins, CO|
|Research Professional Position||No|
|Position Type||Admin Professional/ Research Professional|
|Number of Vacancies|
|Proposed Annual Salary Range||$30,000-$55,000|
|Desired Start Date|
|Position End Date (if temporary)|
|To ensure full consideration, applications must be received by 11:59pm (MT) on||03/03/2019|
|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.
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
|Preferred Job Qualifications||
• Experience in a contract manufacturing or other regulated environment.
•Personal and professional commitment to diversity and inclusion as demonstrated by involvement in teaching, research, creative activity, service to the profession and/or diversity/inclusion activities.
|Job Duty Category||Production and Documentation Responsibilities|
• Support the creation of written procedures for biological manufacturing processes, including purification steps and testing methods for production campaigns.
|Percentage Of Time||80|
|Job Duty Category||Laboratory Maintenance Coordination or Laboratory Coordination|
• 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.
|Percentage Of Time||20|
|Special Instructions to Applicants||
To apply, submit a cover letter which addresses the minimum and preferred qualifications, a resume, and the names and contact information for three professional references. References will not be contacted without prior notification of candidates.
|Conditions of Employment||Pre-employment Criminal Background Check (required for new hires)|
|Search Contact||Amy King | email@example.com|
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 Title IX Coordinator is the Executive Director of the Office of Support and Safety Assessment, 123 Student Services Building, Fort Collins, CO 80523 -2026, (970) 491-7407.
The Section 504 and ADA Coordinator is the Associate Vice President for Human Capital, Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.
|Background Check Policy Statement||
Colorado State University (CSU) 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 (felony and misdemeanor) history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will be conducted when required by law or contract and when, in the discretion of the university, it is reasonable and prudent to do so.
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