Are you the next ASCTxer in our team? Consider a career with ASC Therapeutics, let’s realize your potential together.
Who You Are?
We are seeking applicants with the following attributes. The level of the position will depend on the qualifications of the selected candidate.
The Quality Assurance specialist position is for ASC Therapeutics (www.asctherapeutics.com )This position will be responsible for maintaining and advancing internal quality system to ensure quality oversight of internal QC and analytical group on gene therapy viral vector product characterization and release test; Require applying Good Manufacturing Practice (GMP) knowledge to ensure quality of the therapeutics product manufacturing at external CMOs.
We are rapidly growing and seeking a talented individual to join our CMC team as a full-time Quality Assurance Specialist. The candidate will provide support to the Product Development group.
- BA or BS degree with at least 3 years’ cGMP experience in a pharmaceutical or biotech environment or advanced degree plus 2 years relevant experience.
- Experience in gene therapy pharmaceutical industry with Quality Assurance system.
- Familiar with viral vector manufacturing processes will be important;
- Knowledge of cGMP, GLP (US and EU) and regulatory requirements related to quality testing.
- Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.) Experiences in assay development for gene or cell therapy production characterization and release is preferred.
- Ability to interpret and relate quality standards for implementation.
- Must have good verbal, written, interpersonal, and organizational and communication skills. Detail oriented.
- Familiarity with GCP general principals and documentation is an advantage.
- Position requires 3-5 % travel.
- Contribute to strategic development and implementation of internal QA system and infrastructure development;
- Contribute to developing appropriate SOPs and provide GMP and GLP guidance to internal departments;
- Promote quality awareness throughout the organization; coordinate and provide GMP/GLP training;
- Support the qualification of QC Bioassay activities and method transfers meet regulatory requirements. Perform compliance review and approval of analytical methods, including ddPCR, qPCR, silver stain, western blot, ELISA, cell-based assays; review and approve quality control documents, CoA, assay qualification data and validation reports;
- Work in collaboration with CMO/manufacturing sites to ensure manufacturing compliance with GMP and regulatory requirements of FDA and other regulatory agencies as required; Reviews CMO’s BPR (Batch Production Record), study report, and analytical data for data integrity;
- Coordinate audit activities with consultant and co-audit on GMP compliance of CMOs to ensure all compliance standards are being met and implements the actions necessary to ensure processes are conducted in accordance with the audit plan. Ensure all audits are followed-up and corrective actions are completed implemented and verified.
- Other duties may also be assigned.
- This is a startup environment with opportunity to grow and lead internal Quality Assurance
This position provides a unique opportunity to join and contribute to a fast-paced team, with a cutting-edge technology platform, and ample opportunity to grow with the company.
Benefits at a Glance
ASC provides the following competitive benefits:
- Employee medical, dental, Vison insurance
- Competitive Salary
- Company Paid time off, sick leave and holidays
- Retirement savings plan – 401K plan
- Short/Long term disability plans and company paid life insurance
If you have the drive, passion, experience and are excited by this opportunity and ready to take your career to the next level then Apply Today!
ASC Therapeutics is a division of Applied StemCell, Inc. which focuses on the development of curative therapeutic products that are enabled by its proprietary gene editing platform, TARGATT™ and other gene editing technologies. The company’s therapeutic development pipeline includes several preclinical and clinical stage projects focusing on monogenic blood disorders.
- Vision: To provide cures to patients with intractable diseases through innovative technologies and therapeutics that are both groundbreaking and safe
- Mission: ASC Therapeutics strives to discover, develop, and deliver gene and cell treatments to cure intractable and emerging diseases.
- DNA:Our diverse team has decades of experience in cutting edge stem-cell and gene therapy research. Together we strive to be innovators to provide platforms to revolutionize the way diseases are treated. We are devoted to find solutions for unmet medical needs and passionate about applying our new technologies to change people’s lives for the better. We hope to help patients lead healthier, more hopeful, and happier lives.