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Manager/Sr. Manager/Asso. Dir.-Head of QA,QC-OPEN POOL

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References will not be contacted without prior notification of candidates.

Posting Details

Posting Detail Information

Working Title Manager/Sr. Manager/Asso. Dir.-Head of QA,QC-OPEN POOL
Research Professional Position Yes
Posting Number 201600553AP
Position Type Admin Professional/ Research Professional
Number of Vacancies
Work Hours/Week
Proposed Annual Salary Range $65,0000-150,000
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.

Position Summary

This person is responsible for the design and implementation of policies and procedures at senior operational levels to ensure that GMP quality, control, productions, and team goals and deliverables are met. Relies on extensive experience to maintain and improve a comprehensive systems to support cGMP manufacturing. Managers are responsible for approval of the design and oversight of implementation of policies and procedures to ensure that GMP QC standards, including product release testing, are met during production. Requires an advanced understanding of scientific concepts and have experience in microbial technology and other Bio/pharmaceutical analytical assays. Moreover, it requires advanced levels of experience in communicating (oral and written) in executing quality control assays to support the creation and/or processing of production materials. Employee must work within an FDA recognized GMP Quality System (or similar) using Quality Assurance approved batch cards, SOPs, protocols and/or the like. Continuous 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 is required. Must lead and train other staff members and be able to physically perform complex laboratory techniques in rooms that require specialized manufacturing and bio-containment protective gowning and equipment. Entry into Bio-safety level 3 laboratories is likely. Employee must be able to create complex instructions and develop an environment for staff to make professional judgments with regard to compliance, quality and continuous improvement paradigms. Must be able to oversee, investigate and report on incidents and provide intelligent corrective proposals. Senior Management will ensures that appropriate investigations of deviations, CAPA, and OOS’s are performed and completed correctly. This employee will be required to manage audits (internal and external). Will be responsible for interactions with regulatory agencies and represent BioMARC’s to the agency. Must lead other BioMARC personnel. The work involves isolating and defining unknown conditions, resolving critical problems, developing new theories along with the overall planning, developing, and execution of vital programs. The programs are essential to the missions of the overall organization or affect large numbers of people on a long-term or continuing basis.

Required Job Qualifications

Bachelors degree in the fields of Science, Engineering, Business, Liberal Arts, or Arts in conjunction with the working requirements listed below.

  • Bachelors degree with 10+ years of work related experience.
  • Or a Masters degree with 5+ years of work related experience.
  • Or a PhD with 2+ years of experience if appropriate for their role in CSU research.

Research Associate IV is the level to which a Research Associate III is
promoted, as appropriate.

Senior Research Associate is the level to which a qualified Research
Associate IV is promoted, as appropriate.

Preferred Job Qualifications
  • Management experience in a contract manufacturing organization
  • Management experience in oversight of quality system in support of bio-pharma activities,
  • Management experience in a regulated environment.
  • Experience in engagement with U.S. FDA regulatory authorities related to cGMP manufacturing
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 Primary
Duty/Responsibility

• Oversee Quality Staff: Quality Assurance and/or Quality Control
• Create/Originate written procedures for the evaluation of raw materials, in-process samples and finished product with a high degree of precision and accuracy according to the U.S. FDA rules, guidelines, and industry standards.
• Oversee implement/execution written procedures for the evaluation of raw materials, in-process samples and finished product with a high degree of precision and accuracy.
• Review and approve the written procedures for the evaluation of raw materials, in-process samples and finished product created by other Quality Associates to ensure documentation conforms to regulations and project specification.
• Coordinates with other departments leaders to maximize efficiency and compliance.
• Collaborate with development groups for method transfer and qualification activities as required.
• Participate in cross-team efforts to develop, validate, and implement quality control test methods for new projects.
• Independently analyze and approve data generated by quality testing to ensure specification and regulation are met for each type of test and project.
• Complete sophisticated documentation requirements for all GMP activities following GMP Good Documentation Practices (GDP). Must be able to justify all written records to Regulatory Auditors (e.g., FDA) in person.
• Independently make decisions in regards to maintain quality standards within the department.
• Effectively communicate deliverables and expectation to Quality Control Staff.
• Delegate duties and responsibilities to staff.
• Provide organizational leadership, direction and training in areas such as QA, QC, safety, cGMP, GDP, productions, team leadership etc.
• Provides final decisions for critical assessments for each project through the monitoring of incidents and CAPAs; including the mitigation, closure and archiving plans for incidents/CAPAs as well as all other documentation of the organization.
• Oversees all customer, regulatory and in-house audits. Ensures the appropriate review of documentation in support of method and process validation, as well as product disposition.
• Responsible for the disposition of each project’s mission/goals, deliverables, resources, key participants (internal and external), deadlines, gaps and risks related to sponsorship guidelines, contract specifications, and federal code related to the research process ultimately leading to a pipeline to commercialization.
• Provide direction and feedback on issues along with coordinating responses to client related issues to BioMARC Director, CSU Quality representatives and the sponsor. Maintain and communicate clear directives from sponsor.
• Establishment, maintenance and adherence to all customer policies and procedures as stated in Agreements.
• Ensures BioMARC’s adherence to all regulatory rules and regulations, ensuring that safety and product performance standards are met.
• Act as the Sr. adviser in process and programs and assures adherence to applicable regulations.
• Builds and maintains a quality infrastructure that can ensure that activities and manufacturing records are in compliance with SOPs and regulatory requirements, determines the need for corrective actions, ensures proper documentation, and determines effectiveness of the action.
• Responsible for recognizing and managing each project’s mission/goals, deliverables, resources, key participants (internal and external), deadlines, gaps and risks related to sponsorship guidelines, contract specifications, and federal code related to the research process ultimately leading to a pipeline to commercialization.

Percentage Of Time 80
Job Duty Category Secondary
Duty/Responsibility

• Takes responsibility for maintaining material inventories and equipment qualifications for quality control use. This includes making the right decisions for types of Quality Control grade materials and activities needed to perform regulated quality control functions.
• 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 alert levels.
• Prepare buffers, solvent solutions, and microbial media for scientific use.
• Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP.
• Perform other duties as required.
• Oversees the review and audit of documentation for compliance to good documentation practices and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.).
• Approval of organization’s expectations for testing, control, development study and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met.
• Ensures correct organizational change control procedures and events.
• Directs internal and external audits and assists departments with the coordination of audit information, and recommends appropriate improvement/mitigations.
• Perform complex scientific and or quality data reduction requiring use of independent judgment based on relevant technical experience.
• Manage and record complex meeting actions/research discovery items, prepare meeting agendas and disseminate research project information.
• Oversees strategic and tactical tasks within the organization, other departments within BioMARC, the university and our sponsors. Applies extensive knowledge of the job skills, scientific context, BioMARC and university policies and procedures to complete complex, specialized assignments/task in creative and effective ways. Comprehensive understanding of the general/technical aspects of the job. Work is completed with no supervision and assignments may be completed without established procedures. May determine methods and procedures for new assignments.
• Perform other duties as required.

Percentage Of Time 20

Application Details

Special Instructions to Applicants

References will not be contacted without prior notification of candidates.

Conditions of Employment
Search Contact Kathleen.landon@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 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.

References Requested

References Requested

Minimum Requested
Maximum Requested

Supplemental Questions

Required fields are indicated with an asterisk (*).

Applicant Documents

Required Documents
  1. Resume
  2. Cover Letter
Optional Documents