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$80k–$100k/yr
Full-time
bachelor degree
Posted 9d ago
~40 hrs/week
Responsibilities
The QC Specialist will support the establishment of Plasmid DNA QC laboratories and lead the development, transfer, and validation of analytical test methods. They are responsible for conducting analytical testing, managing deviations and CAPA activities, and ensuring laboratory compliance with GMP standards.
Requirements
Candidates must hold a Bachelor's degree or higher in Chemistry or Biology and possess 8+ years of experience in pharmaceutical or biopharmaceutical quality control. Expertise in analytical testing of biologics and experience with laboratory start-up and equipment commissioning are required.
Full job description
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
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. 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.
#LI-MG1
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
CDMO Services (Research, Development and cGMP Manufacturing for Biologics)
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2014
Headquarters
Fremont, California
LinkedIn followers
9,671
Bionova Scientific is a dynamic, full service, biologics Contract Development and Manufacturing Organization (CDMO) on a mission to deliver the highest quality process development and manufacturing services to biologic drug development companies around the world. Bionova’s renowned scientific expertise and dedication to its customers helps life changing therapies arrive to the market faster and more efficiently. At the heart of Bionova is a team of highly dedicated experts combining strong experience in cGMP biologics manufacturing and process development, with a technology-focused approach and a deep knowledge of the industry. From early stage research material generation to Process Development and GMP manufacturing, Bionova’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.
Offices: 3100 W Warren Ave, Fremont, California 94538, US
How many Healthcare jobs are open in The Woodlands, TX right now?
There are currently 299 open healthcare positions in The Woodlands, TX listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in The Woodlands, TX?
Companies currently hiring include Memorial Hermann Health System, St. Luke's The Woodlands Hospital, Texas Children's Hospital, Compass Group, Regency Integrated Health Services, LLC, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in The Woodlands, TX?
Yes — 16 of the 299 open healthcare positions offer remote or hybrid work (8 remote, 8 hybrid).
How do I apply for Healthcare jobs in The Woodlands, TX?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.