About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is an emerging innovative pharma company based in China’s “Zhangjiang Pharma Valley” and New Jersey in the US, focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases.

Laekna Therapeutics is adopting a two-pronged strategy in new drug development. On the one hand, it continues to enrich its portfolio by introducing global new drugs with the clinical Proof of Concept. The company has obtained the global exclusive rights of four new drug candidates from Novartis. On the other hand, the company’s self-developed innovative drugs will soon enter clinical development stages.

Laekna has set up a team of top global pharmaceutical talent and acquired key technologies. Its leadership team members have over 20 years of experience in new drug development in China and the US, with an exceptional track record in R&D, new drug approvals and commercialization. Laekna is committed to a science-based, innovation-driven approach to create a leading clinical research and development pipeline, and develop first-in-class and best-in-class innovative drugs. It has been developing an international leading platform for new drug research and development to benefit patients.

The detail Laekna Therapeutics information can be found from the website: http://www.leaknatp.com.

Job Summary:

CMC QA provide the strategic direction for a robust, sustainable and cost-effective plan to ensure that new products can reliably and in compliance be brought to market and supplied until their ultimate phase out. You will work in a matrix team and with external CMOs and are accountable for the launch and lifecycle management of the assigned molecule(s)/product(s).

Main Duties:

Provide quality expertise and guidance to the new product development projects and CMC organization throughout the product lifecycle.

Develop and drive the product quality strategy and monitor product quality health and ensure continuous improvement.

Ensure quality supply of assigned molecules(s)/product(s) and related projects for clinical trial and future commercial production.

Ensure appropriate quality standard are applied and implemented to fit for intent use.

Influence and ensure local and global CMOs’ quality management in adherence to ICH guidelines, and the regulations in the major global regulatory agencies, such as FDA/EMA/NMPA.

Specific Scope of Decision-Making:

Development and proposal of product quality plan

Development and recommendation for sourcing ( Raw Material Supplier, CDMO, CMOs）

Approval of product quality strategy alignment for functional initiatives impacting product

Approval of product quality health and performance targets

Approval of product quality risks and actions to mitigate them below given threshold.

Responsibility:

Manage E2E product quality life cycle, serve as quality represent in project team and ensure alignment of quality related activities to meet product/project goals & long-term plans, accountable and responsible for product quality decisions.

Develop and manage product quality plan, recommend and drive mitigations of gaps, opportunities, and risks

Define product quality health metrices and routinely report product quality health status and drive mitigation actions

Drive quality activities to ensure continuous supply to patients

Provide product recommendation for filling readiness and regulatory inspection readiness internal and at CMO sites.

Provide quality input and requirements into product sourcing decisions and QC testing strategy

Accountable for defined “product” specific product quality deliverables and release assigned molecule(s)/product(s) for clinical supply and future commercial supply.

Engage in QMS establishment, implementation and monitoring to ensure appropriate quality standard and procedures are applied in assigned molecule(s)/product(s).

Qualifications:

Bachelor’s degree or above with pharmacy or relevant subjects, specific area knowledge: chemical synthesis, drug product production, aseptic production, chemical analysis is preferred.

Minimum 5 years technical experience in quality / technical positions in quality assurance

At least 3 years quality management experience in pharmaceutical industry.

Have experience in CMO management, or work as plant QA is acceptable.

Have experience in quality system establishment and improvement is required.

Knowledge of product development process, CMC related ICHs guidance.

Knowledge of FDA, EMA, NAMP GMP/GDPs.

Knowledge of small molecule manufacturing and quality control process.

Project management skill is preferred.

With good ability for problem solving and ability of organization and coordination.

With good communication and interpersonal skill.

Laekna Therapeutics is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.