Scientist, Drug Product Development and Manufacturing
Arena is a rapidly growing, fast-paced organization with multiple mid- to late-stage development programs in several exciting clinical indications. Among other things, our Technical Operations group is responsible for the development and manufacture of small molecule drug products supporting the conduct of the company’s clinical development programs. We are currently looking for a Scientist, Drug Product Development and Manufacturing to help develop, manufacture and ensure timely delivery of finished drug products under aggressive program timelines.
Reporting directly to the Head, Drug Product Development and Manufacturing, 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 position will be responsible for various aspects of formulation and process development, process scale-up and validation, and manufacturing. The role will involve working closely with internal team members and external CMOs on technical issues, reviewing and/or writing study reports and portions of regulatory filings, budget preparation, and project management. The ideal candidate will carry out work independently or with minimal supervision and interact effectively through cross-functional collaborations with internal and external team members from various functional departments including Analytical, Quality, and Regulatory.
What you’ll dive into
- Perform and/or manage formulation screening and optimization activities in-house or through CROs leading to the identification and selection of robust dosage forms capable of supporting nonclinical and clinical studies (Phase I through Phase III);
- Oversee and troubleshoot routine and scale-up drug product manufacturing activities at CMOs
- Design and manage Design-of-Experiment studies to define optimal formulations and process ranges
- Work with the CMC project leader to write drug product sections for global regulatory filings.
What we expect
- BS or MS degree in Pharmaceutics, Pharmaceutical Engineering, Chemistry, or related discipline
- 7-10 years of experience in formulation development within the pharmaceutical or biotech industries
- Excellent understanding of the pharmaceutical drug development process and a proven track record of working in cross-functional teams
- Advanced working knowledge of equipment and processes used in the manufacture of multiple pharmaceutical dosage forms (solid oral, liquid, lyopohilized, injectable, topical)
- Experienced in formulation development, process development, clinical manufacturing, and regulatory filings
- Thorough knowledge of pharmaceutical cGMPs
- Proficient using Microsoft Office suite, DOE and other relevant software
- Demonstrated leadership skills
- Strong communication skills, both written and verbal
- Excellent organizational, interpersonal, and negotiating skills
- Proficient in problem solving, issue identification and independent resolution
- Able to work independently
- Able to travel ~20% to contract sites
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
- Opportunities to learn and contribute creative solutions
- Comprehensive health insurance ($0 premium on select medical plans)
- Matching 401k retirement plan
- Paid time off and holidays including a Summer & Winter break
- 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 firstname.lastname@example.org.