Manager Quality Control and Assay Development at BioLife Solutions, Inc.

PanTHERA CryoSolutions, now a part of BioLife Solutions, designs and manufactures cryopreservation solutions for cells, tissues and organs. We are now recruiting for an exciting position in our Quality department and welcome you to apply to join our team! Our employees receive a competitive benefits package, which includes a 401k matching program.

BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor freeze media and HypoThermosol shipping and storage media, ThawSTAR family of automated, water-free thawing products, and evo cold chain management system. For more information, please visit: www.biolifesolutions.com

General Summary And Purpose

The Quality Control Manager & Assay Developer is a core team member of the Panthera Quality Team. This role works as part of an interdisciplinary team to develop, optimize, transfer and validate characterization, in-process and release tests for the manufacturing of ice recrystallization inhibitor-based cryopreservation products.

Duties And Responsibilities

• Accountable for managing, leading and coaching the Quality Control team
• Leads the development, optimization, and validation of analytical chemistry assays with minimum supervision.
• Ensures project deliverables assigned to the QC department are met on time
• Accountable for timely Quality Control testing of all in-process, finished product, raw material, and stability samples in accordance to written procedures.
• Coordinates and processes data analysis
• Coordinates and executes routine analytical assays and their troubleshooting
• Ensures QC equipment maintenance and calibration is done on time
• Carries out ongoing lab sampling performing visual, dimensional, mechanical or chemical analyses of in-process materials, raw materials, final product and stability samples
• Maintains detailed records of all experiments performed
• Supports preparation of annual budgets and oversees Quality Control expenses.
• Responsible for tracking, trending, and reporting on Key Performance Indicators (KPIs). Develops new metrics when applicable.
• Responsible for reviewing and approving Quality Management System (QMS) forms (Deviations, Change Control, etc.) in a timely manner. Responsible for accurate and compliant information on QMS forms.
• Articulates and presents results to the project team
• Supports the elaboration and updating of documentation to ensure that our company complies with GMP regulations and quality standards
• Participates in internal, external, and third-party audits as required.
• Accountable for effective training of team members on approved procedures. Develops training content and delivers training on Quality Control programs
• Contributes to the development of needed records and standards and maintain accurate and detailed files, as required
• Participates in the development of product specifications
  
  

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the team member for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Requirements

• Ability to work independently with minimal supervision.
• Prior experience developing new analytical chemistry methods is required
• Prior experience in method validation is a must
• Prior experience analyzing, summarizing & interpreting data is required.
• Prior experience in the pharmaceutical or biotechnology industry is preferred.
• Experience writing and revising controlled documents is required.
• Able and willingness to follow detailed instructions and SOPs without deviating is required.
• Ability to keep and maintain a clean and orderly work environment is required.
• Excellent organizational skills are required
• Strong attention to detail is required
• High adaptability and responsiveness to new priorities is required
• Must have good visual acuity and color perceptions, and manual dexterity.
• Effective written and oral communication skills.
• Team-oriented player, with a strong work ethic is required.
• Enthusiasm to tackle difficult problems, learn new technologies, and work in an exciting, high paced environment is a must.
  
  

Job Specifications

• BSc degree in analytical chemistry, biochemistry, or related discipline is required.
• 4+ years of experience developing and validating GLP or GMP-compliant analytical assays is required
• 2+ years of experience running and interpreting HPLC and GC analytical assays is required.
• 1+ years of experience managing people is required; additional demonstrated experience leading project teams is preferred.
• GMP experience required
• Microsoft Suite capabilities
• Experience in Good Documentation Practices is a must