POSITION TITLE: CMC Specialist

DEPARTMENT: CMC

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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The Role:

Provide support for various GMP stability programs. This includes creating, implementing, and maintaining stability databases, performing data trending, reporting of metrics, statistical analysis, review of stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations.

What You'll Do:

• Creates, reviews, and revises stability protocols, and reports, specification documents, and participates in stability strategy and protocol design.
• Assists with stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur as scheduled and within appropriate timelines.
• Creates, monitors, and updates stability study trending dashboards and reports metrics regularly.
• Assists with deviations, laboratory investigations, and CAPA
• Provides support to applicable stability sections of regulatory submissions
• Ensures compliance with cGMP and safety requirements.
• Participates in audits as needed.
• Requests and retrieves stability testing data/reports from vendors and shared folders and updates electronic data files accordingly.
• Active role in department and company-wide process improvement initiatives.
• Responsibilities may differ slightly from the above based on specific needs of the business. Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.

What We Look For:

• Experience needed for the Role:
  
  • MS or BS in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalents.
  • At least 3 years of relevant experience in the pharmaceutical or biotechnology industry with a focus on Stability.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Ability to efficiently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment.
  • Demonstrated proficiency and expertise with MS Office programs (Outlook, Powerpoint, Excel, Word).
  • Excellent communication skills, both oral and written.
  • Demonstrated ability to work with a high degree of independence.
  • Strong interpersonal skills.
• Additional Skills & Attributes:
  • Experience working with CROs, vendors, and relationship management.
  • Experience with IND/CTA/NDA filings.
  • Team player who is willing to roll-up their sleeves and get the job done.
• Competencies and Personal Traits:
  • Attention to Detail: Ability to analyze available data and take the time to understand as full a picture as possible to drive successful solutions to complex problems.
  • Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy. Possess the capacity to understand others and to be aware of and sensitive to the feelings, thoughts, and experience of your colleagues and customers.
  • Intellectual Curiosity: A person's willingness and desire to learn new things and dig deeper than the surface. Intellectual curiosity makes learning a much more natural process, instead of just a duty or a chore. When you're intellectually curious, you're more willing and interested to acquire knowledge. You naturally ask more questions and seek to understand why things are the way they are.
  • Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again; collaborative and progress-loving, you honor the past but embrace change because the new is always coming!
  • Organization and Goal Setting: Ability to set goals, delegate appropriate tasks, maintain a focused approach to critical path work and develop structure for yourself and your team to allow for productive, high-quality workflows and decision making.
  • Resolve Conflicts: Practice radical candor in your communication with your team and colleagues as well as participating in active listening to help the other person feel heard and understood.
  • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team with diverse and complimentary skill sets that works together under shared values to achieve significant positive impact in the wider world. Live a clear and sustained demonstration of the daily practice of Ora's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor and the linked behavioral expectations.