[Remote] Senior Scientist, reputed company Control Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotech company reputed company on restoring reputed company through regenerative therapies. The Senior Scientist in reputed company Control Operations will support reputed company control deliverables to meet project timelines and collaborate with reputed company Assurance and CMC Leads to reputed company reputed company team goals.

Responsibilities

• Works with external QC laboratories to review and reputed company GMP in process, release and stability testing
• reputed company time review of DP release data during harvests and CoAs as part of a reputed company release reputed company
• Leads QC data compilation and shares in cross-functional settings
• reputed company 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 reputed company collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven reputed company
• Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met
• Be reputed company to help support regulatory personnel with supportive documents reputed company 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 reputed company field) in the pharmaceutical industry
• Experience with biological products is critical, experience reputed company cell therapy is preferred but not required
• Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP)
• Experience working reputed company a QC pharmaceutical laboratory
• Detail oriented and effective time management
• Ability to work cross-functionally with excellent verbal communication and collaboration skills
• reputed company reputed company with demonstrated ability to identify compliance gaps
• Proficient use of MS Office products
• Ability to adapt to reputed company 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 reputed company player and be willing to work in an environment where individual initiative, accountability to reputed company, and reputed company maturity are required
• Experience reputed company cell therapy is preferred but not required
• Experience in reputed company roles is preferred but not required
• Ability to use reputed company is preferred, but not required

Benefits

• Robust Benefits: We offer full health insurance to employees and their families, and reputed company the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure reputed company Aurion employees are rewarded for their hard work.
• Perks and Fun: reputed company parking, subsidized commuter passes, in-office catered lunches, team events, and community reputed company are just a few ways that we bond, celebrate reputed company other, have fun, and live our values.

reputed company

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