Career
Position
Department
Location
Time

Responsibilities:

1、Responsible for cell culture (expansion, passage, cryopreservation, thawing, etc.) experiment operations

2、Perform experiment in strict accordance with experiment protocol and criteria

3、Fill experiment records accurately and timely, sort and analyze experiment data, summarize and distill experiment conclusion, and prepare lab report

4、Complete projects within specified time as required by the company and customer

5、Strictly observe EHS management procedures in the lab, and take charge of cleaning and maintenance of facilities, equipment, and environment within specified area

6、Prepare and revise SOPs and other documents

7、Perform other temporary tasks assigned by immediate superior

Qualifications:

1、Master's degree or above in biotechnology, pharmaceutical engineering, biochemical engineering, or equivalent.

2、Familiar with basic cell culture operations, including cell thawing, passage, expansion, cryopreservation and other aseptic operations

3、Strong sterility awareness, solid hands-on skills

4、Knowledge of manipulating small- and large-scale production equipment is preferred

5、Practical experience in mammalian cell fermentation is preferred

6、Diligent and steadfast in work, meticulous and detail-oriented, love lab work

7、Strong sense of teamwork, strict observation of professional ethics, and scrupulous abidance of confidentiality

Responsibilities:

1、Strictly follow EHS management procedures in the lab, take charge of cleaning and maintenance of facilities, equipment, environment within specified area

2、Explore and scale up purification method to develop purification process meeting the production requirements of new drugs

3、Responsible for purification operations (including solution preparation, column chromatography, membrane filtration, ultrafiltration, etc.)

4、Accurately and timely take records of experiment, equipment operation, etc.

5、Sort and analyze experiment data, summarize and distill experiment conclusion

6、Engage in routine training on lab management and operation

7、Prepare and revise documents, such as SOPs of new equipment for downstream platform, etc.

Qualifications:

1、Bachelor degree or above, majored in biotechnology, pharmaceutical engineering, biochemical engineering, etc.

2、Proficiency in basic operations of downstream purification for biomacromolecules, such as column chromatography, membrane filtration, ultrafiltration, formulation, etc.

3、Knowledge of small and large scale production equipment operation is preferred

4、Experience in purification of mAb or recombinant protein is preferred

5、Diligent and steadfast in work, detail-oriented and love lab work

6、Strong sterility awareness, solid hands-on skills

7、Strong sense of teamwork, strict observation of professional ethics and confidentiality rules

Responsibilities:

1、Responsible for analysis of items such as protein purity, assay, peptide map, N-terminal amino acid sequence, isoelectric point, pH, osmotic pressure, particulate matter, clarity, visible particulates, etc.

2、Engage in residue detection such as relative binding activity, biological activity, impurity protein A, host cell protein, host DNA, etc. of mAb products

3、Develop and explore potency testing method for protein-based drugs and residue detection method for impurity protein A, host cell protein, host DNA, etc. of protein-based drugs

4、Engage in preparation of technical documents such as product specification, SOPs for analysis, etc.

5、Engage in qualification/validation of analytical method, and prepare analytical method validation protocols and reports

6、Engage in testing and analytical methods transfer for CMO projects

7、Manage culture media, test solution, reagent, etc. for use in Lab

8、Engage in IQ, OQ, and PQ of lab analytical instruments/equipment and calibration management of lab instruments, equipment, and meters

Qualifications:

1、Bachelor degree or above, majored in biopharmaceuticals, pharmacy, etc.

2、Over 1 year of experience in analytical assay for mAb or recombinant-based protein drugs

3、Those who possess (one of) the following experiences would be preferred:

     1)Analytical assay of biological activity, receptor affinity;

     2)residue analysis of protein A, HCP, DNA;

     3)SEC, CEX, peptide map, N-glycan analysis

     4)cIEF, CE-SDS, etc.

Responsibilities:

1、Inspect and supervise workshops for conformance to GMP, SOPs, quality-related documents such as process procedures, take on sampling for validation in workshop, monitoring of environment.

2、Prepare and revise varied inspection SOPs for shop floor, review production records, subject the products to annual quality review, assessment.

3、Responsible for release of raw material, excipient, packaging material, and intermediate product, review of finished product.

4、Identify, escalate, and treat deviations on shop floor in a timely manner, follow up the execution progress.

5、Responsible for varied validation efforts on shop floor.

Qualifications:

1、Bachelor degree or above, majored in biopharmaceuticals, etc.

2、Over 1 years’ work experience, GMP/FDA experience; work experience in biological enterprise would be preferred.

Responsibilities:

1、Cooperate in investigating deviation(s) occurred during purification process, report and escalate the deviations and abnormalities occurred during work timely

2、Responsible for preparation of batch production records for purification process, varied records, initial version or revised version of documents

3、Cooperate in activities such as workshop renovation for GMP compliance and as-built acceptance, etc.

4、Cooperate in setting up the whole GMP documentation system for purification process

5、Carry out production tasks related to purification process

6、Responsible for timely writing, sorting, filing of production records

7、Engage in activities such as selection of equipment for purification process, technical verification, FAT, SAT, IQ, OQ, PQ, etc.

8、Responsible for cleaning, normal functioning, and routine maintenance of buildings and facilities related to purification process

Qualifications:

1、Bachelor degree or above, majored in pharmaceutical engineering, biological engineering, etc.

2、Over 2 years’ experience in protein purification, good at autonomous learning

Responsibilities:

1、Carry out operations of pharmaceutical production according to GMP and quality requirements of the company.

2、Responsible for activities such as cell culture, cell thawing, expansion, cell incubation, and harvest in bioreactor, etc.

3、Assist supervisor in solving technical problems in technology transfer, process scale up, and routine production, improve and optimize production process flow and working method

4、Coordinate, escalate, and address any abnormalities occurred during production process

5、Coordinate storehouse and quality department to carry out activities such as requisition of materials, submittal for analysis, execution of routine validation protocols, etc.

6、Accurately and timely take records of experiment and equipment operation, etc.

7、Engage in equipment and process validation as well as cleaning validation

8、Responsible for maintenance of process and IPC equipment in a proper and timely manner

9、Prepare and upgrade technical documents related to cell culture equipment and process operation

Qualifications:

1、Bachelor degree or above, majored in biology, pharmaceutical engineering, etc.

2、1 to 3 years’ experience in CHO cell culture, with GMP experience

2、Strong communication skills and basic English literacy