Job Details

The senior scientist’s primary responsibility is for the product formulation and product/process development of various technology platforms. This position investigates and conducts research in relevant drug delivery systems for product innovation and process/process improvement. In addition, the scientific role may also support other R&D projects in the portfolio by conducting laboratory bench work and process analytical technology (PAT) designs /studies. This position is in the Pharmaceutical Development group and is expected to focus on various pharmaceutical product development and drug-delivery project teams by providing support on projects pertaining to mid to late stages of drug formulations, process improvement, technology transfer and process transfer to Manufacturing and Operation teams including CMOs/CROs. The scientist is expected to participate in team meetings and proactively interface with internal/external scientists from various disciplines including R&D Engineering, Manufacturing, Regulatory and Quality functions. He/she writes technical reports and presents experimental data to project teams and provides recommendations for next steps. The scientist should have working knowledge of relevant ICH guidelines, especially Q2, Q3, Q5, Q6 and Q11. He/she is required to perform experiments in compliance with relevant regulatory expectations including cGLP and cGMP regulations. Overview Develops robust formulations and processes for various combination drugs, biologic drugs and drug delivery systems. Hand-on experiences in protein formulations and characterization are highly desirable. The scientist is expected to work effectively within the group and with other functional teams in designing experiments to maximize the information obtained from the studies. This scientist also assumes overall responsibilities for the technical conduct of studies and assures that all aspects of technology and process transfers are performed in accordance with regulations and SOP’s. He/she should have working knowledge of relevant ICH guidelines, especially Q2, Q3, Q5, Q6 and Q11. Data review and reporting Reviews and approves the interpretation, analysis, documentation and reporting of results of studies to assure accuracy and in accordance with compliance standards. Interdepartmental and project team participation Participates in project teams. Provides technical input and plays an integral role in the project functional development plans. Communicates with the team leaders and members on a regular basis and promptly notifies functional heads and team leaders of issues. Collaborates with both internal and external QA/QC laboratories by transferring processes and/or methods from R&D to cGMP labs. Scouting new technology evaluation Evaluates available information/literature and provides technical expertise to assess and advice on the safety of new ingredients, compounds, acquisitions and competitor products.

Requirements
* Minimum of 5 years of experience in Chemistry/Biochemistry or relative field in pharmaceutical /biotech companies, specifically formulation and process development of pharmaceutical preparations and/or biological drugs. * Master’s degree and 6+ years of related experience, or PhD and 4+ years of * Experience in biologic drug development and process analytical technology (PAT) are a plus. Regulated cGLP, cGMP training and experience are desired. * Trained in applications for biopharmaceutical formulation development and biologic assays * Understands and creates SOP documentation * Attention to detail and ability to organize and present experimental data to various project teams (use of instrument software, Excel, Power Point, Word) * Excellent communication skills, both verbal and written Requires a Bachelor’s degree in a S&T discipline

Pay $47-58/hr based on experience