About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is a startup biotech company focusing on innovative drug discovery and development. Motivated by the high unmet medical needs of the patients, we are dedicated to developing new targeted therapies to treat cancer and liver diseases. Laekna has strong expertise in both small molecule and antibody discovery and development. Our CEO, Dr. Chris Lu, and the leadership team all have extensive R&D and management experience in global pharmaceutical companies, along with an exceptional track record of new drug approval and marketing. Laekna is a young company full of energy and innovation. Our talented scientists are striving to solve the biggest problems in healthcare and to bring breakthrough medicines to patients.

Responsibilities:

Responsible for analytical method development, validation and transfer for API and drug product to support Laekna’s pipeline products

Oversee analytical development and QC activities at CDMOs, including review and approval of test records, test methods, method validation protocols/reports and stability protocols/reports

Monitor and review CDMO’s release and stability data, assess GMP compliance and perform method performance review

Phase appropriate specification development for starting materials, intermediates, API and drug product

Supervise or conduct investigations e.g. OOS, OOT by collaborating with CDMO and implement CAPAs as needed

Prepare and deliver technical reports, batch analyses, analytical methods, method validation reports etc. for regulatory submissions

Draft and review dossiers for IND/NDA filing and other regulatory related documents as needed

Closely work with project team on the projects outsourced to CDMOs and actively contribute to deliverables and engage in team discussion on issue resolution

Qualifications:

Master with 8+ years or PhD with 5+ years working experience in big pharm, biotech or CDMO companies directly involving analytical method development and validation for API and drug product.

Must have solid knowledge and hands-on experience in analytical method development, validation and transfer for API and drug product to support clinical development and product launch

Familiar with regulatory CMC requirements for FDA/EMA/CFDA and have rich experiences in writing IND/NDA dossiers to different regulatory agencies for multiple products.

Familiar with all kinds of analytical instruments and the trend in analytical chemistry field.

Basic knowledge of API and drug product development and manufacturing processes

Good oral and written communication skills in both English and Chinese