Responsibilities

• Supervise and support formulation development team to develop, optimize, scale-up, and manufacture CTM in support of IND, early and late stage clinical studies.
• Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials.
• Develop dissolution strategy to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage form.
• Work with CMOs or commercial plant to assist gap analysis, risk assessment, tech transfer, process DOE and optimization.
• Coordinate with external collaborators including international Pharmaceutical companies to co-develop formulations and to overlook the projects’ progress.
• Evaluate and manage CMOs to ensure timely delivery of CTMs with high quality.
• Draft and review regulatory filing documents of IND and NDA for NMPA, FDA, EMA and TGA, etc.
• Prepare and participate interactive technical meetings with external collaborators and official reviewers in CDE.
• Collaborate with other functional groups in pharmaceutical development, regulatory affairs, and clinical supply operation and contractors.

Requirements

• Ph.D in pharmaceutical science or related fields.
• Over 10 years’ experience in formulation or drug product development. Overseas working experience in global pharmaceutical company is preferred.
• Familiar with pharmaceutical industry regulations such as ICH, NMPA and FDA guidance etc. IND and NDA experience for FDA or EMA is preferred.
• Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.

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

COMPETENCIES; Knowledge, Skills and Abilities

• Must have a strong Quality Control mind-set with extensive knowledge and experience of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (NMPA, FDA, EMA, PMDA, etc.) requirements for medicinal Drug Product.
• Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
• Must be able to interpret problems and effectively communicate in a productive manner to management and teams.
• Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
• Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
• Must have strong hand-on solid dosage QC testing/operation experience that could immediately form a preliminary decision for an OOS that might trigger a Field Alert Report.
• Must have strong experience of the OOS investigation.
• Must have strong experience for the method validation and transfer
• Must be fluent in both Chinese and English.

Duties and Responsibilities

• Oversee and perform cross-functional QC laboratory assessments and implement improvements to assure Hutch-Med QC expectations would be fulfilled.
• Collaborate with individual CMO QC team and individual cross functions (i.e. Analytical Development, Process, Formulation) to support strategies for improvement and implementation of best practices and automation.
• Responsible for handling the analytical related issues like OOS result at CMO for commercial product in a timely manner and make a quick proposal to management team if marketed product is impacted.
• In charge of the analytical method, specification, stability study, retain sample management for commercial products.
• Lead the Product Quality/Analytical QA team to provide daily oversight on the good compliance of analytical document at Hutch-Med and its CMOs;
• Provide product quality inputs to quality events, like product complaints.
• Participate in the project CMC programing from analytical compliance perspective.
• Develop product quality/analytical team members from both technical and soft skill perspective

Education and Experience

• Bachelors’ degree in analytical chemistry and/or Pharmacy
• Masters and above Degree preferred
• Minimum of 7+ years of Pharma industry experience in a QC or QA role(s) supporting programs in pre-clinical phases through commercial, with at least two years management role
• Strong project management skills and ability to communicate effectively across matrix functions
• Excellent verbal and written English communication skills

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

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

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

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

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