AskBio Inc
Quality Control Analyst
Durham, NC
Sponsorship not specifiedDetected 30 days ago
RecruitingGMPPCRqPCRCRISPRResearchMass SpectrometryCommunication
About the role
- Our principles: - Advance innovative science by pushing boundaries. - Bring transformative therapeutics to patients in need. - Provide an environment for employees to reach their fullest potential.
- Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. - Embrace Responsibility.
- We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. - Raise the Bar.
Responsibilities
- Pioneering science to create transformative molecular medicines.
Requirements
- Bachelor's degree in biology or related field
- Ability to handle multiple projects/teams simultaneously based on general instruction
- Ability to work independently in a fast-paced, highly interactive environment
- Relevant work experience in cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field
- All agencies must have a prior executed service agreement with AskBio prior to any search engagement.
Nice to have
- GDP experience preferred
- Experience with cell-based assays and PCR testing is preferred
- Experience working within a cGMP Quality Control LIMS system preferred
Company info
- Lead innovative science and drive clinical outcomes to transform people's lives.
- Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
- Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
- Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
- Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
- Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
- Perform routine analytical testing including but not limited to cell-based potency assays,
- ddPCR, qPCR, ELISAs, quantitative or limits testing using HPLC techniques
- Prepares laboratory solutions, maintains cell lines, maintain inventory of materials, and other day to day laboratory activities
- Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner
- Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory
- notebook analytical records
- Assist with management of analytical test method supplies and samples as needed
- Ensure lab areas are clean, organized, maintain equipment and consumables
- Our principles:
- Advance innovative science by pushing boundaries.
- Bring transformative therapeutics to patients in need.
- Provide an environment for employees to reach their fullest potential.
- The Quality Control Analyst I will be responsible for performing routine GMP testing on analytical methods in the GMP Quality Control laboratories.
- This position is based on site in Durham, NC and reports to the Associate Director, Quality Control.
- Job Responsibilities
- Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments
- Strictly adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
- Participates in continuous improvement projects in the AD and QC labs
- Support revisions to work instructions, SOPs, forms, protocols, and reports
- AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives.
- The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease.
- AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters.
- With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
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