Colorado State University Biopharma Production Supervisor/Associate - Open Pool in Fort Collins, Colorado
Posting Detail Information
Working Title Biopharma Production Supervisor/Associate - Open Pool
Position Location Fort Collins, CO
Research Professional Position Yes
Posting Number 201800125AP
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)
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, year-long 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.
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
Research Associate I:
0-3 years of professional experience
Bachelor’s degree in the science’s or related field
Research Associate II:
+3 years of professional experience
Bachelor’s degree in the science’s or related field or
Master’s degree in the sciences or related field
Research Associate III:
+5 years professional experience
Bachelor’s degree in the sciences or
+2 years professional experience
Master’s degree in the sciences or
PhD in the sciences
Preferred Job Qualifications
Preferred degree from one of the following areas: microbiology, biotechnology, cell biology, biochemistry, chemical/biomedical engineering, pharmacology, or related field.
Experiences 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 microbiology or cell biology type laboratory.
•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. • 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
• 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
• 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
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 02/01/19 and individuals will need to reapply to any new opening to be considered beyond that date.
References will not be contacted without prior notification of candidates.
Conditions of Employment Pre-employment Criminal Background Check (required for new hires)
Search Contact BioMARCJobs@colostate.edu
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 Executive Director of Human Resources and Equal Opportunity, 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.
Required fields are indicated with an asterisk (*).