Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
- The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (Client) and other biologics by state-of-the-art formulation, processing and analytical technologies. We create intellectual property through new formulation compositions, lean and smart manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
- We are looking for a highly motivated person who supports and drives process development activities for NBEs. The candidate will maintain as well as improve our technological equipment to expend the state-of-the-art and support the development of manufacturing processes for biologics. Furthermore, the candidate will keep and increase the state of operational excellence of our lab. Working closely with analytical and formulation scientists in an integrated group the candidate will develop productive collaborations and communications with scientific and technical teams.
Responsibilities:
- Supporting the process development of parenteral formulations for biologics with a focus on antibody drug conjugates.
- Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
- Being the first point of contact for the operation of advanced NBE process technologies with special emphasis on process unit operation (filling, filtration, lyophilization).
- Continuous thorough maintenance (mechanical, electrical) of process and laboratory development equipment and troubleshooting of technical issues on the machines.
- Builds strong relationships to other functional units (e.g. S&T, combination products, Analytical Development) and supports / advice activities in collaboration with partners.
- Optimize laboratory operations for efficient use of time and resources.
- Document experimental data thoroughly in lab documentation systems, make concise scientific presentations of process results and author detailed scientific technical reports.
- Responsible for compliance with all applicable Client policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Requirements:
- BS or MS in Chemistry, Pharmaceutical, biological, engineering, food science or related discipline with typically 4(BS) or 0-2 (MS) years of relevant experience. or significant technical / industrial experience in the technical field.
- Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.
- Experienced in laboratory systems (ELN) preferred.
- Experience in Microsoft Office (Excel, SharePoint, PowerPoint, and Word) required.