The Director of Drug Substance Development will be responsible for API and synthetic chemistries activities across Landos’ portfolio including route development, process chemistry and chemical manufacturing from early phase development through commercial launch. This position will collaborate with members of the CMC team and Regulatory Affairs to develop and implement API manufacturing and regulatory strategies of development candidates. The Director of Drug Substance Development 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 completely 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 Drug Substance
- CMC Management: Interact with contract manufacturing organizations to plan and execute the production of drug substances for all phases of development. Provide a critical detailed review of specifications, analytical procedures, process chemistry, manufacturing batch records, product labeling, and other CMC data.
- 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. 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.
- Quality: Assist the Head of CMC and Head of Quality to ensure that contract manufacturers operate under cGMP in the manufacture and release of APIs used for CTM manufacture for use in Landos’ clinical trials.
- Regulatory Affairs: Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to drug substance activities. Coordinate and outline the necessary drug substance activities in line with the overall development plan of individual assets. As directed by Head of CMC, author, review and finalize drug substance documents for IND and NDA submissions, as well as annual reports. Maintain a current knowledge of CMC regulations and guidance.
- 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.
- 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 experience in CMC submissions and product development meetings; interactions with regulatory agencies; international experience preferred.
- Ph.D. in organic chemistry, medicinal chemistry or related chemistry discipline.
- Minimum 10-15 years of drug substance experience in the pharmaceutical industry.
- Develops and maintains constructive relations with key internal and external colleagues, e.g., cross functional colleagues within Landos, Alliance Partners, and Health Authority representatives.
- As directed by Head of CMC, evaluate new business development opportunities or participate on due diligence teams.
- As directed by Head of CMC, 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.
- Must be 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.