Biomanufacturing Associate (Production Associate I) - Open Pool

Colorado State University, United States

Updated: about 2 years ago

Location: Fort Collins, COLORADO

Deadline: 28 Jan 2022

Posting Details

Working Title	Biomanufacturing Associate (Production Associate I) - Open Pool
Position Location	Fort Collins, CO
Research Professional Position	Yes
Posting Number	202100394AP
Position Type	Admin Professional/ Research Professional
Classification Title
Number of Vacancies
Work Hours/Week
Proposed Annual Salary Range	30,000-55,000
Employee Benefits	Colorado State University (CSU) is committed to providing employees with a strong and competitive benefits package that supports you, your health, and your family. Visit CSU’s Human Resources website for detailed benefit plan information for permanent full-time and part-time faculty and administrative professional employees in the following University benefit areas. https://hr.colostate.edu/wp-content/uploads/sites/25/2021/01/benefits-summary-afap.pdf .
Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by 11:59pm (MT) on	01/28/2022
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 contract manufacturing or another 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. This pool is valid through January 28th, 2022. Individuals wishing to be considered beyond this date must reapply.
Conditions of Employment	Pre-employment Criminal Background Check (required for new hires)
Search Contact	Darragh Heaslip [email protected]
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. 80523-0160, (970) 491-1715, [email protected] . 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.