QC Specialist

About the role

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. The company is looking for a QC Specialist with 8+ years of work experience, a team player mindset, and expertise in analytical testing of biologics to contribute to the expanding business.

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.

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.

Pay

The base compensation range for this role is $80,000-$100,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.