The Director of CMC will be responsible for CMC-related activities across the portfolio including process chemistry and route development, chemical manufacturing, preformulation, formulation and manufacture of drug product for clinical trials. This position will develop and implement CMC manufacturing and regulatory strategies for both drug substance (DS) and drug product (DP) across 7 product candidates across 14 disease indications. The Head of CMC will be well-versed in analytical and synthetic chemistry, as well as FDA and EMA regulations, in order to navigate the development of small molecule therapeutics for autoimmune diseases. The candidate will be aligned with four fundamental pillars of Landos’ entrepreneurial corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
Manufacturing of DS and DP
- CMC Management: Assist in interacting with contract manufacturing organizations to plan and execute the production of drug substance and drug product related to Landos projects. Provide a critical detailed review of specifications, analytical procedures, process chemistry, manufacturing batch records, product labeling, and other CMC data.
- Medicinal and Synthetic Chemistry: Provide critical insight for synthesis routes of novel chemical entities to advance discovery-based R&D at Landos. Propose, troubleshoot and revise synthetic routes outsourced to contract manufacturing organizations. Provide full evaluation of potential process impurities and formal assessment of their potential mutagenicity/carcinogenicity (ICH M7).
- Data analysis and reporting: Utilize established and novel methods to analyze data. Data types will include but are not limited to NMR, HPLC, MS, in silico docking and surface plasmon resonance, among others. Provide detailed reports of current status of primary assets and new chemical entities. Generate figures, presentations and publications to communicate results with scientific community, investors, and collaborators. Support the development of patents and grants relevant to on-going research.
- Discovery Chemistry: Provide critical insight for synthesis routes of novel chemical entities to advance discovery-based R&D at Landos. Propose, troubleshoot and revise synthetic routes outsourced to contract manufacturing organizations.
- Quality: Develop, implement, manage, audit and maintain GXP quality systems to support developmental and commercial activities for a pharmaceutical company. Develop, manage and maintain a GXP compliant document control system and assist in setting up a robust Quality Management System.
- Regulatory Affairs: Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to CMC activities. Coordinate and outline the necessary CMC activities in line with the overall development plan of individual assets. Author, review and finalize CMC documents of drug substance and drug product manufacturing for IND and NDA submissions, as well as annual reports. Maintain a current knowledge of CMC regulations and guidance.
- Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
- Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
- Lead team members that define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- Manages and develops staff, if required, including staff professional development and project oversight accountability.
- Represents Landos RA CMC in Health Authority meetings and leads preparation activities for meetings with Health Authorities on CMC related matters
- Interacts directly with international Health Authorities, as required. Participates in and/or facilitates agency meetings.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provides solutions to prevent recurrence of issues.
- Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
- Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
- Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Landos, Alliance Partners, and Health Authority representatives.
- Evaluates new business development opportunities or participate on due diligence teams.
- Evaluates change proposals for global regulatory impact and plans global variations and amendments.
- Maintain the confidentiality of all the company deliberations and plans.
- Faithfully performs any other tasks requested by the Chairman, President and CEO.
- Team-science oriented, data-driven, and patient-centric engendering credibility and confidence within and outside the company.
- Act in accordance with Landos’ policies and in alignment with Landos’ corporate culture.