Biopharma Production Supervisor/Associate - Open Pool
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Please see Special Instructions for more details.The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables. NOTE 1: Applications will be accepted on a continuous basis. Candidates are likely to be selected prior to the closing date. NOTE 2: This open pool will expire on 11/30/2017 and individuals will need to reapply to any new opening to be considered beyond that date.
Posting Detail Information
|Working Title||Biopharma Production Supervisor/Associate - Open Pool|
|Research Professional Position||Yes|
|Position Type||Admin Professional/ Research Professional|
|Number of Vacancies|
|Proposed Annual Salary Range||$30,000-90,000|
|Desired Start Date|
|Position End Date (if temporary)|
|Open Posting Date|
|Open Until Filled||No|
|To ensure full consideration, applications must be received by 11:59pm (MT) on|
|Description of Work Unit||
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.
Under the supervision of Production Manager, the Production Supervisor/Associate will be responsible for production activities of a cGMP manufacturing campaign under FDA regulations. This position requires 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 3 laboratory is 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, Engineering, Medicine, Business, or Liberal Arts
|Preferred Job Qualifications||
Preferred degree from one of the following areas: microbiology, biotechnology, cell biology, biochemistry, chemical/biomedical engineering, pharmacology, or related field
•Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
|Job Duty Category||Production|
• Create/implement/execute written procedures for biological manufacturing processes, including purification steps and sample testing methods of production campaigns.
|Percentage Of Time||60|
|Job Duty Category||Quality|
• Complete sophisticated 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.
|Percentage Of Time||25|
|Job Duty Category||Administrative|
• Perform other duties as required.
|Percentage Of Time||15|
|Special Instructions to Applicants||
The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables.
|Conditions of Employment|
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. 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.
|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.
Required fields are indicated with an asterisk (*).
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