Note: The job is a remote job and is open to candidates in USA. Aurion Biotech is a clinical-stage biotech company focused on restoring vision through regenerative therapies. The Senior Scientist in Quality Control Operations will support quality control deliverables to meet project timelines and collaborate with Quality Assurance and CMC Leads to achieve Quality team goals.
Responsibilities
- Works with external QC laboratories to review and track GMP in process, release and stability testing
- Real time review of DP release data during harvests and CoAs as part of a rapid release strategy
- Leads QC data compilation and shares in cross-functional settings
- Able to work with CMO on out-of-specifications and investigations as needed
- Designs DS and DP stability studies, leading to establishment of expiry. This includes protocol review, data review, and report review in collaboration with an external CMO
- Supports technology transfers through data and document review
- Participates in internal and external collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven decisions
- Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met
- Be able to help support regulatory personnel with supportive documents related to regulatory filings
Skills
- MS degree 5+ years' experience, or a BS degree and 10+ years' experience in a relevant discipline (cell biology, biotechnology, or related field) in the pharmaceutical industry
- Experience with biological products is critical, experience within cell therapy is preferred but not required
- Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP)
- Experience working within a QC pharmaceutical laboratory
- Detail oriented and effective time management
- Ability to work cross-functionally with excellent verbal communication and collaboration skills
- Quality mindset with demonstrated ability to identify compliance gaps
- Proficient use of MS Office products
- Ability to adapt to rapid changes and work in a fast-paced team environment
- Ability to work effectively both independently and with other team members
- Ability to travel to CMO locations as needed
- Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
- Experience within cell therapy is preferred but not required
- Experience in lead roles is preferred but not required
- Ability to use Smartsheet is preferred, but not required
Benefits
- Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
- Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
- Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.
Company Overview
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