Scientist / Senior Scientist, Biologics

POSITION OVERVIEW:

Disc Medicine is seeking a Scientist/Senior Scientist to lead external process development efforts in support of GMP manufacturing of the Drug Substance.  The successful candidate will have hands-on training in biologics process development and experience working in a GMP environment. In this role, the candidate will work with CDMOs to support development, tech transfer, and GMP manufacturing efforts. The candidate will perform gap analyses, trend data, and participate in activities towards GMP drug substance manufacturing campaigns. The successful candidate is expected to have a firm understanding of principles of cell line development, process development and exposure to other crucial areas in CMC such as analytical and formulation development. The successful candidate will be an effective communicator, highly organized, detail-oriented, and a quick learner in a fast-paced environment.

RESPONSIBILITIES:

• Assist in leading cell line, upstream and downstream process development activities from lab scale to GMP scale at Drug Substance CDMOs.
• Collect, monitor, and trend critical process and product quality data sets from development and manufacturing runs. Perform data analysis to understand and support process optimization. Work in collaboration with the CDMO to design studies to develop robust cell culture and purification processes and prepare summary reports.
• Liaise with analytical, formulations and QC to advance programs from development to manufacturing.
• Collaborate with stakeholders to support batch record review, deviation investigations, change controls, CAPAs, and process changes.
• Support regulatory filings by providing subject matter expertise and well written summary reports.
• Ensure that the documentation of all drug substance development and manufacturing activities is per internal SOPs, industry standards and regulatory guidelines.

 REQUIREMENTS:

• MS/PhD degree in Pharmaceutical Sciences, Biochemical Engineering or Biochemistry with relevant industry experience (MS with 5-8 years, PhD with 3-5 Years).
• Significant hands-on experience in upstream/downstream process development studies with biologics.
• Demonstrated ability to resolve complex problems in a process development environment. Experience in Design of Experiment (DoE) approaches is preferred.
• Exposure to Process Characterization, PPQ and other late-stage activities is preferred.
• Experience in supporting regulatory files with focus on writing relevant development and manufacturing sections.
• Thorough understanding of inter-dependencies in upstream, downstream, formulation and analytical functions with focus on GMP Drug Substance manufacturing.
• Must be an organized scientist with ability to make scientifically sound decisions, write and maintain records, technical documents, and ensure regulatory compliance in support of pre-clinical, clinical, and commercial manufacturing campaigns.
• Strong problem-solving, troubleshooting, collaborative and written/oral communication skills.
• Ability to travel domestically and internationally (15% of the time) to support audits and manage GMP operations (PIP).
• Ability to handle multiple high priority tasks in parallel to meet organizational goals.
• Thorough knowledge of applicable GXP regulations (e.g., CFRs and ICH).
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges.
• Attention to detail and proper use of tools for information processing and electronic systems.