Company:

Bionova Scientific LLC Job Description:

The QC lab at Bionova, an Asahi Kasei company, in The Woodlands, TX, is seeking a self- motivated and innovative candidate with strong technical communication skills. If you are a QC Specialist with 8+ years of work experience, team player mindset, and expertise in analytical testing of biologics to contribute to our expanding business, please apply. As part of the rapidly growing QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes.

Location:

The Woodlands, TX Onsite Essential Duties and Responsibilities:

Support establishment of Plasmid DNA QC laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols. Assist in implementing GMP procedures, processes, and systems within the Quality Control (QC) team. Provide training to QC personnel on instrumentation, techniques, and analytical chemistry methods as needed. Participate/lead in the development, transfer, and validation of instrument and analytical test methods across various platforms including analytical test methods HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing, wet chemistry and others as required. Support/lead stability studies program by generating protocols and reports and other tasks as required. Contribute/ author technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents as required by project specifications. Lead or oversee method transfer and qualification of analytical test methods (HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing and others) as required. Lead/coordinate/support of internal and external projects related to analytical/Micro/EM. Support/evaluate new technologies and innovations to improve operational efficiency or expand QC capabilities. Participate/support internal and external audits. Initiate and investigate deviations, implement Change Control procedures, and manage CAPA activities. Revise/initiate general QC Standard Operating Procedures (SOPs), test methods, and test method forms as required. Conduct analytical testing for method qualification/validation/transfer, raw materials, in-process stages, lot release, and stability samples Analyze and interpret analytical data to support various initiatives, making recommendations for process improvements. Maintain laboratory equipment according to established procedures. Assist in investigating issues and non-conformities related to products and projects, including troubleshooting equipment and testing procedures to identify root causes of issues and participate in laboratory investigations. Support multi-compendial harmonization efforts (USP, EP, JP) for raw material, in-process, product release, and stability testing. Contribute to maintaining the QC lab in a clean, organized, and compliant manner at all times. Perform any other QC-related tasks as required. Interpret/review analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.

Working Conditions:

This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently. Initially, remote working conditions transitioning to long term permanent, onsite position; occasional travel.

Qualifications:

Bachelor's Degree or above from an accredited institution in Chemistry, or Biology (or closely related degree). Requires 8+ years of quality pharmaceutical, bio-pharmaceutical, or combi-medical device experience, and analytical testing experience on Biologics. In-depth understanding of analytical and microbial test methods and industry-standard analytical tools (HPLC/UPLC, sequencing, PCR, ELISA, microbiological assays, compendial assays, etc.). Experience with new laboratory start-up and equipment commissioning. Hands-on experience in running, qualifying, and validating analytical methods. Creative thinker that can identify and efficiently improve methods to address issues and gaps. Demonstrate ability to work independently and on cross-functional teams. Proven client interactions and project management experience desired. Strong attention to detail. Effective verbal and written communication skills. The base compensation range for this role is $80,000-$100,000. 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