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Career Opportunities
Job Title: Clinical Research Associate (CRA)
Location: Shanghai / Beijing / Guangzhou / Hangzhou / Nanjing / Suzhou / Chengdu /
Jinan / Changsha / Haerbin / Changchun / Shenyang / Zhengzhou / Xi’an

 

Primary

Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring
 

Responsibilities

  • Be familiar with trial execution process of assigned trial
  • Be responsible for following activities:
    • Site selection
    • Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix etc.
    • Site initiation
    • Site monitoring based on applicable monitoring plan
    • Site close out visit
    • Key personnel to coordinate with trial specific vendors to complete the trial related activities.
    • Complete all trial related reports within SOP defined timeline
  • Site level trial master file and investigator site file management
  • Deliver trial related training to site staffs
  • Update site status to project manager at timely manner
  • Prepare all required reports to line manager in a timely manner

 

Qualifications

  • At least 1 year clinical trial on site management experience
  • At least bachelor degree in Clinical Medicine or Pharmacy or related major
  • Good communication skill and team player
  • Good command of computer skill
  • Adequate verbal and written communication skills in English
  • Down-to-earth and hardworking spirit
  • Willingness to travel (up to 75%) of working time

 
If interested, please forward your resume to KellyL@hutch-med.com

Job Title: Production Engineer
Location: Suzhou

 

Responsibilities

  • Participate in or responsible for qualification of process equipment.
  • Participate in or responsible for production related process validation, cleaning validation, etc.
  • Responsible for the creation, optimization and update of production SOP, batch records and other documents.
  • Responsible for review relevant records timely and follow-up execution of on-site ESH and 5S.
  • Support team to organize and arrange production operations according to production plan, assist in the implementation of GMP on production site, complete production operations according to SOP and batch records, and ensure meet the objectives of quality, output, yield and efficiency.
  • Participate in dealing with deviation, change and risk management related to production, solve problems encountered in the production process, and constantly optimize the production process.
  • Responsible for the production of clinical products.
  • Summarize and report production related data, and complete other work arranged by production manager.

 

Requirements

  • Bachelor’s degree or above, major in related pharmaceutical or electrical and automation; at least 3 years’ experience of drug production; related work experience in oral solid production or similar position is preferred.
  • Good communication, coordination and problem solving skills, proficient in English.

 
If interested, please forward your resume to yuhuaw@hutch-med.com

Job Title: Formulation Engineer
Location: Suzhou

 

Principle Roles & Responsibility

  • Participate in the work related to new product introduction and organize the drafting of R&D related contracts.
  • Perform process transfer, process validation and cleaning validation of new products, draft process documents (process flow documents and master batch record, etc.) prior to product commercialization.
  • Participate in product-related design work, including but not limited to: new equipment design, tablet/capsule appearance design, printed packaging material design, inner packaging layout design, etc..
  • Cooperate with the preparation of relevant documents for product registration.
  • Review the validation documents related to the process and cleaning such as revalidation, continued process verification, etc. after commercialization of the product; review the process documents of commercialized products.
  • Cooperate with deviation investigation and change impact assessment in the production process.
  • Cooperate with the work related to the declaration of high-tech enterprises. Apply for R&D related government subsidies.
  • Other R&D related matters.

 

Qualification and Experience

  • Bachelor degree or above, pharmacy related majors.
  • At least five years working experience in oral solid dosage.
  • Familiar with the technical transfer, process validation and cleaning verification/validation.

If interested, please forward your resume to yuhuaw@hutch-med.com

Position QC Chemist
Department QC
Location Suzhou

 

Primary

  • Responsible for Chemical test in QC laboratory

Principle Roles & Responsibility

  • Strictly follow the relevant standard operating procedures and testing method procedure of laboratory;
  • Execute the release testing of raw materials, packaging material, intermediate products and finished products, and initiate the relevant testing reports.
  • Execute the finished product stability testing, and initial the relevant stability reports.
  • Initial and revise the chemical test methods and specifications for all materials (including raw materials, excipients and packaging material), intermediate products and finished products;
  • Initial and revise the protocol of method transfer and validation for chemical testings;
  • Execute method transfer and validation according to protocol, initial and review the validation report accordingly;
  • Initial and revise the standard operating procedures for relevant equipment, instruments, reagents, test solution, reference standards and volumetric solutions;
  • Initial and revise the validation protocol for laboratory chemical analysis instruments; cooperate in the qualification/validation, maintenance and calibration of instruments used for chemical testing.
  • Responsible for the chemical testing for utility qualification, key production equipment qualification, product process validation and cleaning validation;
  • Report the OOS results, and conduct laboratory investigation per line manager instruction;
  • Provide specific information when communicating with government drug testing agencies;
  • Responsible for the safety, health and environmental protection (EHS) of itself position;
  • Complete other tasks assigned by line manager.

Qualification and Experience

  • College degree or above in pharmacy relevant major;
  • 2 years of relevant work experience;
  • With good physical and chemical testing skills and knowledge;
  • Familiar with chemical laboratory procedures, laboratory instrument operation and regulatory requirements;
  • Experience with chemical method validation is preferred;
  • Experience with USP and EP is preferred.

If interested, please forward your resume to Yuhuaw@hutch-med.com