Posted 2 weeks ago
Salary depending on Experience
The Manager of Pharmaceutical Development will provide technical and project leadership to bring new pharmaceutical products to market. This individual will develop, document and execute the Chemistry, Manufacturing and Control (CMC) activities for projects at all stages of R&D, in alignment with the product development plan and program timelines of STAQ Pharma.
- The candidate is a highly motivated and goal driven leader who can work closely and efficiently with a multidisciplinary team.
- Responsible for performing and executing analytical research and development to support STAQ’s strategic projects and product development goals.
- Research, develop, and implement new drug formulations and procedures.
- Work closely with multiple stakeholders in assessing the feasibility of new drug products and procedures.
- Direct STAQ’s stability program including formulating, filling, and troubleshooting OOS and deviations.
- Prioritize and efficiently manage multiple projects and studies.
- Develop and validate internal analytical processes and procedures.
- Research and procure appropriate new API and excipients.
- Review literature and patent data to aid in developing novel and cutting-edge pharmaceutical products.
- Succinctly present stability progress and data to stakeholders.
Experience and Required Skills:
- PhD or PharmD. with 3+ years of drug development experience.
- Strong attention to detail and accuracy.
- Prior experience in bringing various drug formulations to market (i.e., Injectable, nasal, topical…etc).
- Familiarity and knowledge of USP, FDA, and ICH requirements in the context of pharmaceutical development.
- Prior cGMP and/or 503B experience is a must.
- Prior analytical experience with HPLC/UHPLC, GC, FTIR, MS, NMR is preferred.
- Excellent verbal and written communication skills.