The Director of Drug Product Development will be responsible for drug product related activities across Landos’ portfolio including formulation development and drug product 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 drug product manufacturing and regulatory strategies for Landos’ drug product candidates. The Director of Drug Product Development will be well-versed in formulation technologies, formulation development, 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 Product
- Drug Product Management: Manage contract manufacturing/research organizations to plan and execute the production of CTM for clinical trials. Provide a critical detailed review of specifications, analytical procedures, manufacturing batch records, product labeling, and other drug product data.
- Formulation Development: Direct formulation development activities with contract manufacturing/research organizations for Landos clinical candidates.
- Drug Product Analytical Methods and Specifications: Collaborate with Landos’ Head of Analytical Development and contract manufacturing organizations to develop analytical methods and establish phase appropriate specifications for drug products.
- CTM Manufacture: Work with Clinical and Regulatory Affairs to establish CTM delivery timelines to meet company goals. Manage contract manufacturing organizations to deliver CTM to meet clinical timelines.
- Upon request 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 CTM for the use in Landos’ clinical trials.
- Regulatory Affairs: Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to drug product activities. Coordinate and outline the necessary drug product activities in line with the overall development plan of individual assets. As directed by Head of CMC, author, review and finalize drug product 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 pharmacy/pharmaceutics, pharmaceutical chemistry or related scientific disciplines.
- Minimum 10-15 years of drug product development 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.