Investigator, Sterile Formulation
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jun 7 2021 GSK is seeking an individual with strong background in Pharmaceutical Chemistry, Physical Pharmacy related field, you will have the opportunity to utilise skill set in executing preformulation and formulations of small molecules transiting from pre-candidate selection to Phase I and beyond. You will have the opportunity to use creative thinking to drive drug development of a variety of sterile product dosage forms. Key Responsibilities: Sense and identify gaps (classical issues e.g. physical & chemical instability, local tolerability, solubility) in early development of candidate selection, and proactively advise/steer modality based preformulation activities to ensure robust candidate selections, in collaboration with discovery chemistry, automation and developability groups in matrix set-up. Design and execute formulation activity them from pre-clinical to clinical phases, with greater emphasis on preformulation aspects to get it right at first time as much possible. Interface and contributes to CMC miles stone and provide scientific data-based risk identification process at early and late stage sterile projects. Work closely with early stage DMPK and Safety groups to troubleshoot solubility, stability and local tolerability related issues with early stage drug candidates. Carefully review form and version screen data package and judge / identify potential polymorphs/metastability issues in context of sterile formulation processes lyophilization, milling, autoclave. etc, and advise on suitability of selected form and version for proposed drug product modality. Collaborate with API and material characterization groups for understanding polymorphism landscape and be vigilant about its impact on drug product development. Work closely with sterile pilot plant for GLP and clinical manufacturing and define processes that is compatible with Sterile Pilot Plant expectations and norms, activity includes authoring batch records drafting and ensuring successful clinical supply manufacturing. Contribute to regulatory document review and writings. Share/communicate results with supervisor and participate in governance processes to communicate results with the line management as we well as broader Pharm. Dev. stakeholders. Proactively engage and seek assistance from other scientists to solve problems. Comply with data integrity and health and safety norms set by GSK. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD in Physical Pharmacy/Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences, Materials Science, or related discipline Experience and expertise in at least one preformulation area listed: solution equilibria, pH Solubility, aggregation and modelling, rate profiling, degradation kinetic, degradation pathways, polymorphism, phase mapping / characterization, thermodynamic profiling e.g. free energy vs. temperature profiling, and physicochemical aspects of small drug molecules. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong understanding of physicochemical properties of drug molecules (preformulation) and with line of site to develop sterile formulation of various modality, including solution, lyophilized and nanosuspension. Scientific mind set to apply fundamental in routine troubleshooting with sense of urgency. Agility / adoptability to learn and go deep into subjects that is not primary skill of applicants. Learning agility to expand their knowledge Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. 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