Disc Medicine

Research Scientist

• Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function.
• Oversee development of standard protein analysis methods through external vendors and guide transfer analytical methods to separate analytical and QC testing facilities.
• Develop analytical techniques to measure product and process impurities.
• Strengthen relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.
• Provide oversight into external testing facilities for non-GMP and GMP testing.
• Lead method performance investigations, troubleshooting, and laboratory investigations.
• Working and up-to-date knowledge of ICH guidelines and other regulatory guidance.
• Author, review and edit SOPs, protocols, reports, and quality related documentation for internal and external stakeholders.
• Provide authorship and review for regulatory documents for multiple countries.
• Collaborate cross-functionally across multi-disciplinary teams including Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain, and others.

Principal Scientist – Analytical Development, Clinical Quality Control

Director

• Provide leadership to multiple technical elements of drug product development for Disc Medicine’s biologic drug product programs.
• Lead selected clinical and/or commercial formulation studies for antibody and/or biologics programs.
• Lead drug product process development and characterization activities for selected unit operations supporting early and/or late-stage clinical programs up to and including process performance qualification batches (PPQ).
• If necessary, participate in selecting and recommending appropriate external providers (CMOs/CROs), to support formulation and fill/finish process development.
• Provide significant technical leadership to drug product process transfers to CMOs as well as oversee drug product formulation, process development, and manufacturing at contract development and manufacturing organizations (CDMO)s.
• Provide expertise across various areas of biologics drug product development, such as in-use compatibility, extractables/leachables, and filter validation studies.
• As necessary, contribute to device selection, design control, and/or validation activities for subcutaneous delivery systems, such as pre-filled syringes, needle safety devices, and/or autoinjectors.
• Form effective relationships and collaborate well with the CMC leader(s) and CMC functions, including drug substance, analytical development, quality control, supply chain, and quality and regulatory organizations.
• Contributed to the budget management of assigned programs.
• Engage with CMC and/or Executive Leadership, as appropriate, to proactively identify and communicate technical risks and provide scientific recommendations for mitigation plans.
• Contribute to a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.

Associate Director, Drug Product

• Manage quality activities for biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines.
• Method validation and method transfers to and from CDMOs.
• Lead and or participate in specification setting activities for early and late-stage biologics programs.
• Manage method life cycle.
• Author, review, and approve method transfer protocols and reports.
• Author, review, and approve method validation protocols and reports.
• Author, revise, and approve governing SOPs, protocols, reports and memos.
• Manage Quality System records for QC activities.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

Associate Director, Analytical Development, Clinical Quality Control

• Evaluate, select, and manage CDMOs for QC stability testing.
• Direct stability studies per ICH guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve SOPs, stability protocols, and reports in accordance with current GMP, ICH, and global regulatory guidelines.
• Create, implement, and manage stability databases, forecast stability testing, and report on metrics, perform data trending and statistical analysis to support expiry dating.
• Manage Quality System records for QC Stability: create, assess, review Deviations, Change Controls, CAPAs, and other applicable stability-related investigations and events.
• Oversee the sourcing, characterization, qualification, retesting, and inventory management of primary and working reference standards.
• Author and review the stability and reference standard sessions of the global health authority dossier for clinical trials and commercial licensure.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

Director, Clinical Quality Control

Compliance

• Perform submission readiness quality checks and updates on MS Word and PDF files per company style guide and health authority guidance.
• Execute report and multi-file publishing activities and manage related processes to meet regulatory standards.
• Manage Veeva RIM HA Questions, Meetings and Commitment databases
• Assist Regulatory Operations submission manager with Veeva RIM data entry and submission-related tasks (pre- and post-dispatch).
• Manage investigational maintenance submission tasks as resources allow or are prioritized by management, e.g. IND investigator submissions. Oversight to commensurate with experience.
• Assist submission team members with document uploads.
• Create and manage document templates used for regulatory submissions.
• Manage StartingPoint training documentation and serve as SME to deliver training to regulatory document authors.
• Perform Veeva RIM metadata audits as assigned
• Review and/or author best practices, work instructions, and SOPs for regulatory operations tasks and present as requested.
• Interact with functional document owners to communicate findings and negotiate resolution steps.
• Participate in Regulatory Operations process improvement and system initiatives
• Provide input for applications associated with the job function and participate in User Acceptance Testing (UAT) as requested.

Principal Scientist – Analytical Development, Clinical Quality Control

Associate Director, Drug Product

Associate Director, Analytical Development, Clinical Quality Control

Director, Clinical Quality Control

Manager, Global Regulatory Operations