Description
The Quality Control Associate III is responsible for performing routine in-process, release and stability testing for drug substance and drug product samples. The successful candidate will be leading and participating in method qualification/validation/transfer activities in alignment with ICH guidelines. Additionally, the incumbent will have the opportunity to interact with cross functional stake holders and represent Quality Control (QC) at third party vendor meetings. Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies.
Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products. Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Requirements
- Perform routine in-process, release, and stability testing, including but not limited to, qPCR, ddPCR, cell-based assays, TCID50, ELISA, etc.
- Participate in establishing GMP assays in-house (transfer of qualified/validated methods from contract testing laboratories (CTL’s) to in-house laboratory.
- Participate in the peer-review of results generated as part of release/stability testing, qualification/validation/method transfer activities, etc.
- Author and/or review SOPs, test methods, study protocols/reports, CoA, etc.
- Initiate change controls, deviations, CAPA and/or performing investigations, as applicable resulting from GMP testing.
- Assist with the setup of GMP QC laboratory, including but not limited to, procurement of equipment, consumables, and reagents, implementing equipment logbooks, etc.
- Assist in the management of external vendors as it pertains to all aspects of GMP testing, including transfer, qualification, validation, and monitoring of routine assays.
- Represent QC at vendor/CTL as single point of contact (SPOC).
- Participate as a subject matter expert (SME) during audits and inspections.
- Support the team in establishing sample management, stability, reference standard and specification processes.
- It should be noted that this job description is subject to change at any time.
About you:
- Bachelors degree in Biological Science or related field
- Minimum of 5 years of QC experience in a GLP/GMP environment, preferably in a biotechnology company.
- Advanced proficiency with in vitro assays encompassing immunology, molecular biology, and/or cell biology such as ELISAs, PCR, and mammalian cell-based assays.
- Ability to evaluate analytical methods according to ICH guidelines.
- Experience participating in internal and external audits, preferred but not required.
- Highly motivated with the ability to work independently and in a team.
- Detail oriented with strong written and verbal communication skills.
- Working knowledge of Microsoft Word, Excel, and PowerPoint.
Benefits
- Annual bonus
- 401k matching up to 3%, 50% on the next 2%
- Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
- 20 days PTO
- 5 days Sick leave
- 6 weeks Parental Leave
Company Values:
Aim Higher – Our motto and values.
- Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
- Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
- Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.
To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together!
