Job Description：
Position: CMC Manager (Protein or Nucleic Acid)
Location: Yangpu, Shanghai
Key Responsibilities:
- Management of CMC operational activities, including but not limited as following: assessment of critical quality attributes, critical process parameters, in-process controls, process validation, starting material and drug product quality and characterization, reference standards, stability studies.
- Coordination of development tasks towards collection of required information and contribution to respective documents (e.g. briefing books, IND, study plans and reports) in close collaboration with other technical teams and the regulatory affairs team.
- Communication with CMOs and analytical laboratories for GMP manufacturing.
Requirements:
- Master degree or above with significant CMC experience in the pharmaceutical industry.
- Working experience in CMC/GMP management or Project/Program management.
- Knowledge of formulation and production processes relating to pharmaceutical development (preference for specific knowledge of big molecule purification, drug delivery, nanoparticle preparations and/or RNA or DNA-based products).
- Ideally first experience in supporting the transfer of products from development to market.
Position: Senior Project Manager
Location: Yangpu, Shanghai
Key Responsibilities:
- Project manager for new drug development programs responsible for planning and managing execution of the full development process for a product including CMC, clinical, and regulatory activities.
- Work with R&D Project Management team lead to plan new programs and then implements the plans.
- Generates the Project Plan document including definition of project goals and objectives, scope, actions, risk assessment, timelines, project budget, the deliverable, milestones, defining roles and responsibilities, and assigning resources.
- Manage execution of the plan, updating the plan as necessary through change management.
- Control risks related to success of the project including risks to quality, budget, and timelines.
- Plans, attends, and coordinates project team meetings.
Requirements:
- Master degree or above in a Scientific discipline.
- A minimum of 3+ years of project management.
- A minimum of 3+ years of biotech/pharma experience in a GMP environment (preferred) .
- Ability to operate in a fast-paced dynamic environment and effectively process multiple avenues of communication and requests simultaneously.
Position: R&D Scientist (Biochemistry or Immunity)
Location: Yangpu, Shanghai
Key Responsibilities:
- Ability to provide scientific and technical leadership in the management, design and execution of a clinical research program.
- With a broad range of skills and experience, this individual is a critical component of the Development Process, demonstrating a capacity for collaboration and innovation with consistently high productivity.
- Explores subject area and defines scope and selection of problems for investigation through conceptually related studies.
Requirements:
- PhD in Biochemistry, Molecular Biology, Immunology or a closely related field.
- Cellular, biochemical, and in vitro pharmacology skills. Strong background and advanced practical laboratory experience; additional cellular metabolism or immunology experience is desirable
- A broad understanding of molecular and cell biology concepts and techniques (flow cytometry, ELISA, Western blotting), IF/confocal microscopy, and apoptosis/proliferation assays are highly desirable.
- Excellent interpersonal, verbal and written communication skills to facilitate intramural cross-functional and external collaborations.
- Self-motivated, energetic and able to work in a diverse team environment.
About RNACure 
We have worked on the simple, one-step mRNA Drug Discovery Platform, from mRNA synthesis, early discovery for new targets, and a rapid expanding pipeline. We focus on the mRNA-based vaccines and therapies of severe diseases. Powered by the cooperative labs, in-house mRNA manufacture capabilities and future new target discoveries, we aim to find the path to the cutting-edge spectrum of mRNA therapy. RNACure will offer you a comfortable platform with deep understanding of mRNA science and industry, and competitive income.
Contact:
Email: [email protected]
Website: www.rnacure.com