Senior Manager Quality Control

Company Information

Nature's Toolbox, Inc. (NTx) is advancing the healthcare industry with their cutting-edge biomanufacturing solutions. NTx, based in Rio Rancho, New Mexico, is using innovative systems like NTxpress® and NTxscribe® to create life-saving medicines in an eco-friendly and sustainable way. Their proprietary biomanufacturing process uses hollow fiber bioreactors to support the increasing demand for mRNA-based vaccines and protein therapeutics. This easily scalable process enables NTx’s partners to increase production and streamline operations to meet changing global demands.

Your Impact

We are seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The Senior Manager will provide leadership in a fast paced, collaborative QC analytical laboratory that supports testing of research material as well as commercial and clinical biological and chemical products. In addition to performing product testing, the manager will provide cross-functional support forability programs, sample management and inventory of critical reagents. The ideal candidate will have extensive laboratory compliance experience, exceptional attention to detail and have experience designing, implementing, and maintaining a quality control program that is compliant with the applicable regulatory guidance.

Your Responsibilities

• Oversee the daily activities of the QC laboratory in support of large molecule release, stability analysis, in-process testing and finished product testing.
• Provide knowledge and expertise using various QC methods like FT-IR, LC-MS, CGE, HPLC, and ELISA.
• Support the QC team leading assay development.
• Represent the analytical group for internal audits, client audits, regulatory inspections, investigations, and client inquiries.
• Work with team members to plan and support a pathway to GMP QC laboratory operations and build the infrastructure for an efficient and successful QC laboratory that supports both research and development activity, and routine commercial manufacturing activity.
• Skilled at mentoring, developing and inspiring staff of all skill levels to excel and reach their full potential technically and professionally.
• Routinely meet with staff one on one, and as a team to enhance team infrastructure, enhance compliance culture, implement efficiency initiatives, develop a strong cross-trained staff within a culture that promotes safety.
• Participate in the hiring and leadership of a team, mentorship of staff, and promote career development opportunities.
• Provide hands-on training, mentorship, and support bench testing, as needed.
• Perform deviation investigations and corrective action process/system improvements.
• Participate in Quality Management Reviews.
• Support routine assay troubleshooting and development of novel assays or 2nd generation assays to improve analytical outcomes.
• Routinely perform data review of QC analytical test data.
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing schedules and team milestones are achieved.
• Lead QC team and collaborate with Process Development by providing technical support during analytical method qualification, validation, and transfer into the QC laboratory using the site Quality Management System (QMS).
• Execution of compendial methods and internally qualified methods used by Quality Control. Monitoring and revisions via change control of method related procedures.
• Provide support for equipment IQ/OQ/PQ and computer system validation for laboratory instrumentation, analytical equipment troubleshooting and routine equipment maintenance.
• Implement and support stability protocols, summary reports, product specifications, SOPs, guidance documents and analytical methods.
• Identify departmental gaps, design collaborative solutions, and carry out laboratory improvements.
• Establish an incoming raw material QC workflow with appropriate assays and lot and result tracking.
• Responsible for assuring the secure archiving of analytical results, primary data and adequate storage of retained samples.

Who You Are

• BS in Biochemistry, Chemistry or related field with 8-12 years of experience with a minimum of 5+ years of hands-on experience managing a cGMP compliant laboratory.
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, ISO) as they relate to the support of manufacturing and release / stability testing / method validation.
• Extensive knowledge of use of multi-compendial assays (USP, EP, JP) in a GxP environment.
• Understanding of biologic manufacturing processes.
• Excellent communication and collaboration skills.
• Experience with routine QC assays and raw material analysis especially in the context of RNA biologics and cell-free manufacturing processes.
• Equipment qualification and method validation experience.
• Attention to detail and highly organized.

This position is located in Rio Rancho, NM.

At Nature’s Toolbox, we are a small team of great minds with an even greater vision. Join us today and help us to change how life saving therapeutics are manufactured today. For good.   Apply today! www.ntxbio.com/careers/

Nature’s Toolbox Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

NTx is not accepting unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to NTx, including unsolicited resumes sent to a NTx mailing address, email address, directly to NTx employees, or to NTx's resume database will be considered NTx property. NTx will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. NTx will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.