Scientist, Analytical Sciences (Chemistry)
Arena is a rapidly growing, fast-paced organization with a start-up mentality. Our Technical Operations group is responsible for analytical characterization of small molecules supporting the conduct of the company’s multiple clinical development programs. We currently need a Scientist, Analytical Sciences who will develop or optimize analytical methods under aggressive program timelines. The position will be responsible for various aspects of analytical method development, qualification, and validation, and will be called upon to play a support role in working with CMOs, reviewing or writing portions of regulatory filings, and project management. Importantly, the position will also entail hands on analytical testing and method troubleshooting.
Reporting to the Principal Scientist, Analytical Sciences, the position is a critical, highly visible, hands-on role within the department that affords considerable opportunity both to grow in responsibility and to work on multiple projects as part of a talented team of drug development professionals. The ideal candidate will carry out work independently or with minimal supervision, evaluate data and prepare associated reports and documentation, and interact effectively through cross-functional collaborations with internal and external team members from various functional departments including Manufacturing, Quality, and Regulatory. The Scientist, Analytical Sciences will also serve as a key resource for coordinating and managing multiple activities within the Analytical Services group.
What you’ll dive into
- Generation and analysis of data from multiple analytical techniques (HPLC, GC, MS, FTIR, UV, KF, dissolution, etc.), and communicate results to other team members
- Reviewing and evaluating analytical test results generated by contract organizations (CMOs and CROs)
- Preparing or reviewing method development, validation and transfer protocols and reports, analytical methods, specifications, SOPs and other key documents
- Interacting with analytical scientists within and outside the company to ensure timely completion of activities
- Tracking and organizing workloads and resources within the Analytical Sciences team
- Working in a multi-disciplinary team environment keenly focused on delivering results
What we’re expecting
- BA/BS or MS degree in Chemistry, Analytical Chemistry or a related discipline
- 4+ years hands-on pharmaceutical industry experience with demonstrated competence in analytical method development and validation covering a wide range of analytical techniques
- Detail-oriented, well-organized with good planning skills
- Ability to work in a fast-paced environment
- Unwavering commitment to quality and compliance with industry regulations
- Superior written communication and computer skills (MS Office, MS Project, Visio, etc.)
- Working knowledge of ICH guidelines, GxPs, 21CFR and Annex 13 requirements.
- Working with CMOs and other contract service providers
- Experience in the transfer of analytical methods between laboratories
- Regulatory document authoring, coordination and/or submission
- Ability for occasional travel
- Pharmaceutical small molecule drug development experience
What you’ll get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
- The ability to contribute to the growth of an important group within the Tech Ops team
- Opportunities to learn and contribute creative solutions to a variety of challenges
- Comprehensive health insurance ($0 premium on select medical plans)
- Matching 401k retirement plan
- Paid time off and holidays
- Company celebrations
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at email@example.com.