Associate Director of Analytical Development

Full Time
Remote
Posted 1 month ago

Position Summary:

The Manager of Analytical Development will be responsible for analytical chemistry activities for both drug substance and drug product development from early phase development through commercial launch. This position will work closely with members of the CMC team to develop analytical methods for both drug substance and drug product for Landos’ product candidates. The Manager of Analytical Development will be well-versed in analytical chemistry, method development validation, as well as FDA and EMA regulations, 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. 

 

Key Responsibilities:

 

Manager of Analytical Development

  • Analytical Development Management: Interact with contract manufacturing organizations to develop phase appropriate analytical methods and method validation related to Landos projects. Provide a critical detailed review of specifications, analytical methods, analytical development reports, validation reports and other data.  
  • Discovery Chemistry: Provide analytical oversight of novel chemical entities to advance discovery-based R&D at Landos. Assist the Director of Drug Substance Development with the evaluation of potential process impurities and formal assessment of their potential mutagenicity/carcinogenicity (ICH M7). 
  • Responsible for drug substance and drug product stability programs.
  • Data analysis and reporting: Utilize established and novel methods to analyze data. Data types will include but are not limited to NMR, HPLC, MS, GC.
  • Quality: Assist the Head of CMC and Head of Quality to ensure that contract manufacturers operate under cGMP in the manufacture and release of drug substance for CTM manufacture and for the manufacture and release of CTM for use in Landos’ clinical trials.  

Regulatory

  • Regulatory Affairs: Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to drug substance/drug product analytical activities. In collaboration with the CMC team, author, review and finalize drug substance/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.

Education/Experience: 

  • Ph.D. in analytical chemistry or related chemistry discipline with minimum 5 years of analytical chemistry experience in the pharmaceutical industry.
  • MS in analytical chemistry or related chemistry discipline with minimum 10 years of experience in the pharmaceutical industry.

Other

  • 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.

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