Production Associate I

Updated: 2 months ago
Location: Fort Collins, COLORADO
Deadline:

Posting Details


Posting Detail Information

Working Title Production Associate I
Position Location Fort Collins, CO
Research Professional Position No
Posting Number 201900144AP
Position Type Admin Professional/ Research Professional
Number of Vacancies
Work Hours/Week 40
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.

Position Summary

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
• 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 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
• 0-1 year experience in a microbiology or cell biology type laboratory.

Diversity Statement

•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.


Essential Duties

Job Duty Category Production and Documentation Responsibilities
Duty/Responsibility

• Support the creation of written procedures for biological manufacturing processes, including purification steps and testing methods for production campaigns.
• Support the creation of controlled documents such as specification sheets, production records, protocols, reports, SOPs and other directive documents.
• Implement/execute written procedures for biological manufacturing processes, including cell propagation and harvest, purification steps and testing methods for production campaigns with accuracy and reproducibility.
• Complete 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.
• Perform both simple and complex laboratory procedures such as bacterial and mammalian cell culture; viral propagation and harvest; UF/DF, TFF and chromatography based purification; and other laboratory processes and methodologies.
• Support the analysis of complex data sets, summarize findings, and chart corrective actions.
• Must consistently exercise discretion and judgment to meet production and safety standards in GMP and/or BSL designated environment.

Percentage Of Time 80
Essential Duties

Job Duty Category Laboratory Maintenance Coordination or Laboratory Coordination
Duty/Responsibility

• 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.
• Supports the maintenance of the ISO status as well as the clean room status of each of the GMP room. This involves the physical cleaning of floors, walls, ceilings, equipment and other surface areas in these controlled rooms.
• Identify training deficiencies, provide recommendations for training and where applicable provide training.
• Perform laboratory activities in a timely, efficient and concise manner.
• Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP.
• Perform other duties as required.

Percentage Of Time 20

Application Details

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 | amy.king@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 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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