Process and Analytical Development Manager job Fort Collins Colorado
Process and Analytical Development Manager job Fort Collins Colorado
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Process and Analytical Development Manager Job

Employer Name: BioMARC SpiderID: 9295896
Location: Fort Collins, Colorado Date Posted: 1/14/2020
Wage: 65,000-120,000 Category: Biotech
Job Code:

Job Description:
The Process and Analytical Development Manager is part of the contract manufacturing organization of BioMARC, part of the Infectious Disease Research Center at the CSU Foothills Campus. This position will be responsible for the establishment and/or development of “wet laboratory” procedures or methods for process development an analytical development activities to support biopharmaceutical manufacturing activities. Process development duties will include the design and implementation of development laboratory studies to support improvements in biological manufacturing process and sample testing methods, including but not limited to the execution of technology transfer, risk assessments, and development of process optimization, scale up efforts and downstream processing to accomplish project goals and milestones to be consistent and within regulatory guidelines for biopharmaceutical manufacturing. Employee must work within an FDA recognized Quality System (or similar) using Quality Assurance-approved test methods and batch cards as needed, SOPs, protocols and/or the like. The ideal candidate will be familiar with technology transfer of existing assays, development of new assays, and preparation for assay qualification. Furthermore the ideal candidate will be familiar with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Quality Assurance/Control. Please be aware this position is grant funded and the salary range is finite. To read a full job announcement and to submit a job application, please visit: CSU is an EO/EA/AA employer and conducts background checks on all final candidates.

Job Requirements:

• Bachelors degree and 10 years of work-related experience
• Masters degree and 5 years work-related experience
• PhD and 2 years of work-related experience.

Job Criteria:
Start Date:
Position Type:
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Company Profile:
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.

Contact Information:
Contact Name: Amy K Company Type: Employer
Company: BioMARC at the IDRC, part of Colorado State University
City: Fort Collins
State: Colorado
Zip: 80521
Web Site:

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