Posting Detail Information Working TitleAssociate Director of Manufacturing Operations Position LocationFort Collins, CO Work LocationPosition is fully in-office/in-person Research Professional PositionNo Posting Number202500952AP Position TypeAdmin Professional/ Research Professional Classification TitleManagement II Number of Vacancies Work Hours/Week40 Proposed Annual Salary Range$130,000-170,000 Employee Benefits Colorado State University is not just a workplace; it’s a thriving community that’s transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact. + Review our detailed benefits information here. (https://hr.colostate.edu/wp-content/uploads/sites/25/2021/01/benefits-summary-afap.pdf) + Explore the additional perks of working at CSU here. + For the total value of CSU benefits in addition to wages, use our compensation calculator (https://hr.colostate.edu/total-compensation-calculator/) . + Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in (https://hr.colostate.edu/prospective-employees/our-community/) ! Desired Start Date Position End Date (if temporary) To ensure full consideration, applications must be received by 11:59pm (MT) on07/17/2025 Description of Work Unit Founded in 1870, Colorado State University is among the nation’s leading research universities and enrolls approximately 32,000 undergraduate, graduate, and professional students. Located an hour north of the Denver metro area, Fort Collins is a vibrant community of approximately 157,000 residents that offers the convenience of a small town with all the amenities of a large city. Fort Collins is situated on the Front Range of the Rocky Mountains with views of 14,000 foot peaks, and offers access to numerous cultural, recreational, and outdoor opportunities. The Infectious Disease Research Center ( IDRC ) at the foothills campus of Colorado State University is a unique and lively hub of translational biology that integrates academic research, entrepreneurial companies, and a world-class bio-manufacturing operation unified under one roof. Featuring one of the nation’s most significant infrastructures for working with high consequence pathogens, industry and academic researchers can mingle as they apply cutting edge biotechnology tools to address some of the world’s most pressing health threats. Bio-manufacturing of drugs to be used in clinical trials is performed under FDA regulated conditions within a high containment environment. BioMARC is a CSU operated contract development manufacturing organization ( CDMO ) of cGMP compliant material for use in early phase clinical trials. It was 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 Associate Director of Manufacturing Operations (Ass. Dir MF) will be responsible for the overall organization, operational and project leadership in support of cGMP biopharma campaigns to produce early phase clinical material. Responsibilities will include operational, technical and regulatory leadership cGMP production activities and working in collaboration with other team leaders manage and coordinate the successful completion of complex interdisciplinary project tasks in a timely manner. The position requires an advanced understanding of scientific concepts, experience in viral vaccine cGMP production and other Bio/pharmaceutical methodologies as pertains to technology transfer and scale up for manufacturing in a cGMP regulated environment. Requires proven experience in managing multiple different cGMP campaigns in a CDMO environment, including space and resource scheduling and capacity planning. Employee will be expect to work within and meet the expectations of an FDA cGMP compliant Quality management System, actively participate in risk management strategies, and participate in internal and external Quality audits. Experience in biosafety pertaining to BSL -2/ BSL -3 containment with both viral and bacterial high consequence pathogens including Select Agents is strongly preferred. Experience in mammalian cell culture, viral propagation, bacterial fermentation, ultrafiltration/diafiltration, tangential flow filtration, and large-scale chromatography are essential. Employee must be able to effectively communicate complex instructions and develop an environment for staff to make professional judgments regarding compliance, quality and continuous improvement paradigms. Employee must have demonstrated ability to function at a high level in a collaborative team environment and give input into complex decisions which focus on overall team performance in delivery of results meeting or exceeding quality standards within the prescribed timelines and project segment budgets. The employee must be able to oversee, investigate and report on incidents or deviations and provide effective corrective and preventative action proposals. The successful candidate will be expected to meet all requirements to pass a background check for full approval to work with CDC Tier 1 Select Agents. Required Job Qualifications + Education and Work-Related Experience + BS, MS or PhD in biological sciences or relevant engineering discipline, with years of experience as outlined below: + BS degree and 15 or more years of work-related experience, or + MS degree with 12 or more years of work-related experience. + Ph.D. MS degree with 8 or more years of work-related experience. + Experience in management of cGMP manufacturing in compliance with U.S. FDA regulatory guidance. + Experience in operating and managing biopharma activities under BSL -2 BSL -3 level. Preferred Job Qualifications + Knowledgeable in mammalian cell culture, microbial fermentation, purification, biologics equipment operation, and CIP / SIP operations. + Knowledgeable in process development, technology transfer, equipment scale-up, equipment validation, and facility startup. + Ability to identify, investigate, and solve process and equipment problems. + Experience in working with Tier 1 Select Agents + Effective written and oral communication skills Essential Duties Job Duty CategoryLeadership/management Duty/Responsibility + Oversee BioMARC cGMP biomanufacturing including Upstream and Downstream Operations groups to support the production of material for use in pre-clinical and phase I to phase II clinical studies. This includes managing and planning the short and long-term production, facility and staff schedules. + Responsible for coordination of technical aspects of biomanufacturing functions in accordance with project needs/contract deliverables and applicable regulatory guidance’s for use of high consequence pathogens and cGMP biomanufacturing. + Create/implement/execute/oversee written procedures for process cGMP production of project-specific materials, intermediates, and final products. + Lead the troubleshooting of cGMP upstream and downstream process, product, and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive actions. + Ensure compliance to cGMP Phase appropriate practices and expectations for all materials and equipment used in scientific and production activities are prepared according to relevant SOPs. + Build, train, and develop skilled teams through training and mentorship. Ensure staff are trained in general and process-specific activities, equipment operation, and relevant regulations. + Drive cross-functional collaboration with Facilities and operations, Process and Analytical Development, Quality Assurance, Quality Control, and other BioMARC and CSU functional groups to support successful product development and cGMP production Percentage Of Time75 Job Duty CategoryAdministrative/Technical Duty/Responsibility + Participate in internal and client meetings as well as regulatory Audits. + Assist in the maintenance of the facility and equipment in a cGMP compliant and ready state. + Contribute to development of project estimates for Quality Control, Process Development and Manufacturing with respect to materials and time resource requirements through Project Management and Business Development for client project Relative Order of Magnitude and project proposal quotes. + Focus on continuous improvement and remaining current on relevant industry and regulatory expectations, guidance’s and trends. Percentage Of Time25 Application Details Special Instructions to Applicants To apply, please upload a cover letter that addresses the required and preferred job qualifications, a resume, and the contact information for three professional references. References will not be contacted without prior notification to candidates. CSU is committed to full inclusion of qualified individuals. If you are needing assistance or accommodations with the search process, please reach out to the listed search contact. Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution. Conditions of EmploymentPre-employment Criminal Background Check (required for new hires) Search ContactDarragh Heaslip, Darragh.Heaslip@colostate.edu EEO Colorado State University ( CSU ) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Background Check Policy Statement Colorado State University 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 for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also 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 Requested3 Maximum Requested3 Supplemental Questions Required fields are indicated with an asterisk (*). Applicant Documents Required Documents + Cover Letter + Resume Optional Documents