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Biopharma Production Supervisor/Associate - Open Pool

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening.  To apply for the position, please click the Apply for this Job link/button.

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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 Details

Posting Detail Information

Working Title Biopharma Production Supervisor/Associate - Open Pool
Research Professional Position Yes
Posting Number 201600962AP
Position Type Admin Professional/ Research Professional
Number of Vacancies
Work Hours/Week
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.
This open application pool is a continuous, open-ended advertisement for those candidates interested in applying to the Production Supervisors/Associates pool. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates in the pool will be screened. Additional information about the applicant pool and how to apply are listed at the end of this document.

Position Summary

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
+ 0-5 years experience

Preferred Job Qualifications

Preferred degree from one of the following areas: microbiology, biotechnology, cell biology, biochemistry, chemical/biomedical engineering, pharmacology, or related field

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

Job Duty Category Production
Duty/Responsibility

• Create/implement/execute written procedures for biological manufacturing processes, including purification steps and sample testing methods of production campaigns.
• Independently analyze complex manufacturing data sets, summarize findings, perform risk analysis, and chart corrective actions. Must consistently exercise discretion and judgment to meet production standards in GMP environment.
• Perform both simple and complex laboratory procedures such as cell culture, protein purifications, DNA/RNA manipulations, immunohistochemistry, etc.

Percentage Of Time 60
Job Duty Category Quality
Duty/Responsibility

• 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.
• Support in the creation of controlled documents such as specification sheets, production records, protocols, reports, SOPs and other directive documents.
• Support the clean room maintenance of the production and support rooms. This involves the physical cleaning of floors, walls, ceilings, equipment and other surface areas. Must analyze microbial flora results and respond to contaminant levels.
• Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP.

Percentage Of Time 25
Job Duty Category Administrative
Duty/Responsibility

• Perform other duties as required.
o Facilities, Operations and Validation department support
o Clean Ops Unit Support
o General Operational Duties
• 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.
• Perform other duties as required.

Percentage Of Time 15

Application Details

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.
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.

Conditions of Employment
Search Contact BioMARCJobs@colostate.edu
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. 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.

References Requested

References Requested

Minimum Requested
Maximum Requested

Supplemental Questions

Required fields are indicated with an asterisk (*).

Applicant Documents

Required Documents
  1. Cover Letter
  2. Resume
Optional Documents