Job Description：

• Responsible for pre-formulation studies for innovative drug, including but not limited to determination of solid-state Physicochemical Properties, solubility, stability, powder properties, polymorph screening and salt form selection, etc.
• Responsible for daily management and maintenance of lab instruments, performing IQ/PQ/OQ calibrations as assigned, drafting validation procedure, relevant SOPs, study records and reports.
• Prepare work protocols, progress reports and final report for assigned projects.
• Assist the formulation team with operating efficiently to solve relevant formulation problems encountered in the early stage of drug development.

Qualifications：

• Bachelor’s degree or above, major in pharmacy, pharmaceutical and other related science discipline, with 3 to 5 years of experience.
• Extensive knowledge of drug’s ADME, have relevant experience in pre-formulation area or Formulation R&D of drugs.
• Familiar with analytical techniques and analytical method used to characterize physicochemical properties, familiarity with formulation and process development of solid dosage forms.
• Have the ability to carry out multi-projects at the same time and plan the project schedule reasonably.
• Must be able to write reports in both Chinese and English, good problem-solving skills, communication skills, and teamwork skills.

Please send your CV to hr@xihuasci.com  

Job Description：

• Provide analytical support and collaborate with the CMC team in impurity control and structure characterization .
• Establish the  acceptance criterion for starting material, intermediate and API and responsible for related method development and validation work.
• Responsible for analytical method transfer of SM, Intermediate, and API.
• Responsible for the isolation of impurity standard, characterization and qualification.
• Analytical method development, validation and transfer for DP.
• Stability research, including accelerated and long-term condition for API and DP.

Qualifications：

• Bachelor or above degree in analytical chemistry or related field, pharmaceutical analysis is preferred.
• Good English writing and speaking skill.
• Self-motivated, collaborative and effective communication skill.

Please send your CV to hr@xihuasci.com  

Job Description：

This position will be mainly responsible for biological drug analysis, including but not limited to cell and gene therapy product, nucleotide drugs analytical research and protein-antibody structure analysis.

• Maintain, operate and troubleshoot analytical instruments including liquid chromatography and high resolution mass-spectrometer.
• Develop and validate analytical methods for cell and gene therapy products or nucleotide drugs.
• Develop, execute and optimize analytical study plans for characterization of physicochemical properties, mass spectrometry analysis and functional properties of antibodies.
• Conduct data analysis and reporting tools such as Proteome Discoverer, ProSightPC, BioPharma Finder, MassLynx, XCalibur, etc.
• Document experimental data, draw relevant conclusions and write reports.
• Support and contribute registration filing in the field of expertise.
• Collaborate with all scientific functions to achieve cross-functional project goals.

Qualifications：

• MS or above in Chemistry, Analytical Chemistry, Biochemistry or related field.
• In-depth knowledge of biologics analytical techniques including but not limited to UV-VIS, Micro-flow imaging, capillary IEF, CE-LIF, RP/IEX/SEC-HPLC, HRMS such as Orbitrap and Q-ToF, SPR/BLI, ELISA, etc.

Please send your CV to hr@xihuasci.com  

Job Description：

• Proficient in organic synthesis of unit process. Ability to complete work activities under the direction.
• Good experimental skill, good laboratory safety awareness, timely problem feedback and effective communicating.
• Expertise in literature reading, ability in problem analyzing according to literature.
• Complete required documentation for all work activities according to Good Documentation Practices, including the protection of intellectual property rights.
• Daily laboratory management.

Qualifications：

• Bachelor’s Degree or above in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical Engineering or relevant.
• Expertise in theoretical knowledge of organic chemistry, familiar with organic reactions, skilled in experimental operation.
• Ability to handle multiple priorities and meet established deadlines.
• Good sense of responsibility, execution ability, proactive, good at communication, good team spirit and cooperation ability.

Please send your CV to hr@xihuasci.com  

Job Description：

• Proficient in basic lab analytical instruments such as HPLC, GC and LCMS, finish the experimental work under the guidance of project leader.
• With good operation skills, good laboratory safety awareness, timely problem feedback and effective communicating.
• With expertise in literature reading, ability in problem analyzing according to literature.
• Complete required documentation for all work activities according to good documentation practices, including the protection of intellectual property rights.
• Participate in daily analytical equipment maintenance.

Qualifications：

• Bachelor’s Degree with a minimum of 2 years’ experience or Master’s Degree with a minimum of 1 year experience in pharmacy, analysis or relevant major. Familiar with API analysis and stability testing.
• Skilled in HPLC, GC, LCMS, Karl Fisher as well as wet chemistry assays.
• Expertise in literature search, proficient in Microsoft Office and other related softwares.
• Strong problem solving skills.
• Have quick learning ability, executive ability, communication ability and stress management ability.
• Good team player.

Please send your CV to hr@xihuasci.com  

Job Description:

• Lead R&D team and responsible for process development, optimization and amplification. Lead the product transfer tasks and projects.
• Manage experimental records and report regularly according to registration requirements.
• Cooperate with Analytical Group in synthesis, separation and purification of the impurities.
• Responsible for the project management and staff management of R&D team, including technical training, performance assessment, etc.
• Responsible for the laboratory EHS.

Qualifications：

• Bachelor’s Degree in Organic Chemistry, Pharmaceutical Chemistry or relevant with a minimum of 10 years’ experience in pharmaceutical industry.
• Strong verbal and written communication skills in English.

Please send your CV to hr@xihuasci.com  

Job Description：

• Responsible for protocol designing and executing, performance evaluating of formulation and process development.
• Responsible for formulation and process development and optimization, package material compatibility, package designing, transport condition determination, stability studying and pilot manufacturing of projects.
• Assist and participate the technical transfer from lab R&D, scale up to pilot production and process validation.
• Conduct research according to requirements, specifications and GMP regulations, make the original records under the guidance of regulations, organize the relevant documents, write research reports and review relevant application dossiers about formulation process.
• Responsible for daily management and maintenance of formulation lab equipment
• Complete the assigned work by superior on time.

Qualifications：

• Bachelor’s degree or above, major in pharmaceutical, pharmaceutical engineering, pharmacy or other related science discipline, preferred to experience in pharmaceutical industry.
• Good command of primary searching methods of literature and information, excellent skills to read English references.
• Understanding the regulations and technical guidelines related to R&D, including but not limited to GMP compliance.
• With teamwork spirit, good communication and coordination skills, meticulous and responsible.

Please send your CV to hr@xihuasci.com