Quality Control Manager, Chemistry Unit

Job Description

At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal. Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.

Position Summary:

A quality control manager is responsible for the management of personnel in their unit, facilitates, equipment, regulatory and documentation related to the quality control laboratory.  QC managers report directly to the quality control director. 

The quality control manager of this unit is expected to: understand protein chemistry and related assays (HPLC, ELISA, Endotoxin, pH, DNA) have strong time management skills; be able to coordinate, facilitate and organize resources, be able to handle multiple activities simultaneously, be detail orientated and accurate, and have a passion for continuous improvement.  

Responsibilities include but are not limited to:
 

• Supervise and train all lab personnel in the QC lab

• Provide professional mentorship
• Provide guidance in scientific work related to protein chemistry and related assays
• Assign short term and long term tasks
• Develop relationships/correspondence with CSP’s to ensure compliance to SAB policy
• Analyze, interpret and review all data and test results

• Assist in QC Out of Specification Investigations and Deviations

• Oversee management of OOSI policy and deviation assignments
• Assist in planning resulting investigations
• Oversee all OOSI conclusions and deviation decisions
• Review all related documentation

• Conduct assays related to research, upstream, downstream, and DP test samples

• Be proficient in specific assays in order to aid in research evaluation, in process work, stability work, and product release
• Have knowledge of all assays run in the QC lab in order to participate in trouble shooting
• Take part in necessary assay development
• Ensure continued compliance to assay SOPs and QC Programs
• Ensure the suitability, stability and storage of assay controls

• Write and revise SOPs and data records related to analytical test methods

• Draft ROPs, SOPs, data records, protocols, reports and all supporting data for analytical assay either developed at SAB, or from contract service provider
• Ensure that all QC SOPs are consistent in structure and content

• Oversee QC reagents and QC equipment and facilities

• Ensure that QC reagents and supplies are inventoried and ordered appropriately
• Draft and implement a QC IQ/OQ/PQ Program for acquiring equipment
• Ensure that all equipment in QC is classified according to SAB Equipment Program
• Ensure that all equipment is up to date on PM, certification, and/or calibration
• Ensure the control of the QC laboratory and necessary equipment
• Oversee general lab cleaning

• Work as a team member with scientists from other departments at SAB to provide scientific and technical support as needed

Qualifications: 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
 

Education, Experience and Certifications: 

• Bachelor’s degree and over  5 years experience managing a protein chemistry lab
• Experience managing personnel
• Understand protein chemistry and protein assays (HPLC, ELISA, Endotoxin, pH, DNA)

Language Skills:
Individual should possess strong communication and leadership skills.  Should be able to effectively present information one-on-one or small groups. Should be proficient in Microsoft Office software (Word, Excel, PowerPoint and Outlook).

Mathematical Skills:
Basic mathematical skills to consist of addition, subtraction, multiplication, and division.  Able to calculate dilutions, concentrations, molarity.  Knowledge in significant figures and statistical analysis.

Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand, and sit.  The employee must be able to lift and/or move up to 50 pounds.  Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus.  The employee will view a computer monitor for long periods of time.

Physical Requirements/Working Conditions: Job requires good physical mobility.  Ability to move 50 pounds by mechanical means.  Be able to sit for extended periods of time.

Working Environment:
Duties will be performed in a normal laboratory and BSL2 laboratory setting.

ADA: 
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.