Essential Functions of the Job:

Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method;

Familiar with HPLC/CE method validation in release inspection and write method validation report after method validation;

Prepare qualified samples to ensure the smooth operation of pre-clinical；

Draft the original experiment record and filing documents for IND;

Take responsibility of the general operation of the protein analytical laboratory facilities;

Plan, execute and manage both routine and non-routine projects simultaneously with general criteria for results;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutical analysis or related field;

Above college related to bioprocessing or biopharmaceutical production.

Essential Experience:

College degree with a minimum of 2 years of large Biomolecule analysis experience; May have less experience in bachelor and above;

Master the theoretical knowledge of biochemistry;

Experience in drug registration verification is a plus.

Essential Functions of the Job:

Lead and manage the Microbiological team for overall Microbiology activities in compliance with cGMP;

Promote collaboration and communication with other functional areas and clients to ensure timely completion of Microbiological activities to meet project timeline;

Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs;

Lead the specification and procurement of equipment, start-up, commissioning and testing of Microbiological Laboratories for clinical and commercial biologic products;

Lead the technology transfer of Microbiological methods, testing protocols and etc.;

Manage the program of testing encompassing raw materials, environmental monitoring, critical utilities (e.g. WFI, PW, special gases, HVAC), intermediates, bulk drug substances, and drug products;

Provide technical support as the Subject Matter Expert (SME) level for guidance on test methods and procedures;

Initiate and review methods and procedures for completeness and accuracy;

Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

BS degree in Biochemistry, Microbiology, Immunology, Molecular/cell biology or a related discipline;

Essential Experience:

Minimum 5 years of QC relevant management experience in Anti-body/Bio-pharmaceutical/Vaccine industry;

Knowledge of standard requirements for plant facility monitoring and basic biological testing as stated by GB, CP, USP, EP, GMP;

Working knowledge and hands-on test experience in relevant industry;

Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.

Essential Functions of the Job:

Review calibration and maintenance activities and schedule needed, as well as arrange work within the team while coordinating with clients as needed;

Maintain calibration laboratory and/or departmental accreditation and quality systems. Perform laboratory and/or departmental administration and management;

Manage and perform and/or support method qualification and validation;

Create and review methods and procedures for completeness and accuracy;

Maintain testing equipment at a high level to quality to ensure accuracy and consistency of test results;

Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;

Responsible for the inventory management of all media and reagents used in QC testing;

Partner with Subject Matter Experts and/or take responsibility for the design of special project studies;

Ensure the timely disposal of tested samples and archive of retention samples;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

BSc (preferably Biology or Chemistry) or related life sciences degree.

Essential Experience:

Minimum 3 years of relevant experience in a cGMP QC operations for Analyst;

Solid experience in Biopharma/Pharma manufacturing and support equipment is essential.

Essential Functions of the Job:

Manage team of scientists and technicians to complete 1-3 formulation projects in parallel approximately every six months;

Develop and improve methodologies and technologies relating to protein formulation (focus on MAbs) including standard protocols based on product category;

Develop and improve methodologies and technologies relating to protein formulation for intermediates, drug substance and drug products including standard protocols based on product category;

Characterize processes sufficiently for Phase I through to BLA;

Author protocols, reports, technology transfer protocols/reports and other technical documents (i.e. Master Formula, specifications) as part of the product development and technology transfer process;

Solves problems using multiple problem-solving tools and techniques as well as using appropriate resources, personal knowledge and experience with whatever data are available given the situation;

Take responsibility of the general operation and maintenance of the protein formulation laboratory facilities;

Manage annual department expenditure and project CAPEX in line with budget;

Comply with Company Policies and Procedures and contribute positively to Company Morale; Plans, executes and manages both routine and non-routine projects simultaneously with general criteria for results;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

Advanced post-graduate qualification (MSc or PhD) related to bioprocessing or biopharmaceutical production.

Essential Experience:

MS degree with a minimum of 3~4 years and Ph.D. degree with a minimum of 2~3 years of pharmaceutical formulation experience;

Experience in managing staff of at least 2 technical specialists;

Expert knowledge in protein biochemistry related to protein formulation and characterization of MAbs and recombinant proteins;

Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.

Essential Functions of the Job:

Manage a group of scientists and technicians to complete 1-2 Downstream projects in parallel approximately every six months;

Develop and improve methodologies and technologies relating to protein purification (focus on MAbs) including standard protocols based on product category;

Develop and improve methodologies and technologies relating to protein purification for intermediates and drug substance including standard protocols based on product category;

Authors’ protocols, reports, technology transfer protocols/reports and other technical documents (i.e. Process Description, specifications) as part of the product development and technology transfer process. Author documents align with CMC section of IND/CTD packages;

Support technical progress and regulatory filing of related products;

Supervise technology transfer to clinical manufacturing;

Take responsibility of the general operation and maintenance of the protein purification laboratory facilities;

Prepare and present capital expenditure requests for Downstream laboratory equipment;

Maintain effective, collaborative, and frequent interactions with client and other department to ensure harmonization in scientific and technical approaches;

Other reasonably duties as requested by Company Senior Management from time to time;

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.

Essential Experience:

BS degree with a minimum of 4~6 years and MS degree with a minimum of 3~4 years of large Biomolecule purification experience;

Experience in managing staff of at least 2 technical specialists;

Expert knowledge in protein biochemistry related to protein purification and characterization of MAbs and recombinant proteins;

Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.

Essential Functions of the Job:

Perform as assistant functions in the qualification of MFG-USP area and equipment, as well as the GMP facility commissioning;

Manufacture clinical and commercial material according to schedule which is compliant with cGMPs and safety regulations;

Ensure operations are carried out according to documentation (batch records and SOPs);

Responsible for the accurate, safe, environmentally friendly, and quality compliant operations of the upstream manufacturing process;

Perform as assistant functions for creation and on-going maintenance of all MFG-USP related equipment, policies, and procedures;

May author URS, MBR and other technical documents;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Biopharmaceutics, Bioengineering, Bioprocess or other related fields.

Essential Experience:

College degree or above and at least 1-year experience in biopharmaceutical based GMP manufacturing;

Hands-on experience in operating disposable bioreactors at scale over 500L in GMP facility;

Good oral and written communication skills. Technical writing ability is required;

Advanced computer system skills for Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook).

Essential Functions of the Job:

Operate and maintain the vial washing machine, tunnel, filling machine, capping machine, Autoclave and other equipment according to the post SOP;

Participate in filling and capping operations and ensures scheduled activities are performed as planned;

Fill in MBR, equipment and other auxiliary records as required by SOP;

Participate in investigation of the deviation, change and quality risks in production process;

Take responsibility of the general operation and maintenance of the fill finish facilities and equipment;

Maintain effective, collaborative, and frequent interactions with other departments to ensure harmonization in scientific and technical approaches;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

Advanced post-graduate qualification (CS，BS or Master) related to bioprocessing or biopharmaceutical production.

Essential Experience:

CS degree with a minimum of 0~3 years and BS or Master degree with a minimum of 0~2 years of pharmaceutical fill finish experience; Experience in aseptic production in Grade B area is preferred;

Master the theoretical knowledge of pharmaceutical;

Ability to bear certain stresses. Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook).

Essential Functions of the Job:

Responsible for downstream production and ensure scheduled activities are performed as planned;

Improve production process of downstream to make operation more reasonable;

Familiar with purification，filtration and bulk filling. Make sure the equipment to work smoothly;

Have skills to draft documents, such as general documents, SOP, BPR and so on;

Staff training and safety management;

Investigate and handle the deviation, change and quality risks in production process;

Take responsibility of the general operation and maintenance of the downstream MFG facilities and equipment;

Maintain effective, collaborative, and frequent interactions with clients and other departments to ensure harmonization in technical approaches;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

Advanced post-graduate qualification (BS or Master) related to bioprocessing or biopharmaceutical production.

Essential Experience:

BS degree with a minimum of 1~2 years of pharmaceutical downstream manufacture experience;

Expert knowledge in downstream MFG related to purification process and GMP quality request of MAbs and recombinant proteins;

Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.

Essential Functions of the Job:

Review and mark-up design drawings to align capacity and function with Company strategy and provide practical and easily-maintained design. Recommend and approve preferred vendors for equipment and spares.

Selection of process equipment and instruments including consumables and spare parts.

Prepare, review and update documented User Requirement, Functional Specifications and Detailed Specifications.

Review and approve the SAT, FAT, Commissioning and Qualification Protocols. Participate in execution of SAT, FAT, Commissioning and Qualification.

Write and update the SOPs related to management of process equipment (e.g. System ID, system validation status) and provide the training to the users.

Maintain the process equipment list as the latest version if any update and prepare periodic reports of the process equipment status.

Generate the process equipment maintenance plan, and together with a Scheduler, establish the process equipment Maintenance Master Schedule.

Critically assess spare parts requirement to generate the purchase list of the safety stock. If any shortage after consumption, reorder the parts.

Support calculation of the annual maintenance budget and take actions to control expenditure within the budget.

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Bachelor degree in engineering or pharmaceutical production.

Essential Experience:

Minimum of 4 years of experience in process management within pharmaceutical or medical device industries. Or at least 8 years of industry experience in calibration in pharmaceutical, medical device, healthcare, or food industries.

Ability to push the activities moving forward according to the schedule.

Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English.

Essential Functions of the Job:

Technical Analysis: including electrical system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design (energy efficient), constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

Develop equipment/systems preventative maintenance plans including the coordination of annual contract services, ordering of replacement components/parts, and schedule coordination.

Hands-on involvement with the troubleshooting, maintenance and operation of site automation systems.

Individual will be responsible for site BAS (Building Automation System) and CMS (Central Monitoring System) operations, preventative maintenance program, planning and coordinating the annual utility system and site shutdowns.

Evaluation of site BAS (Building Automation System) and CMS (Central Monitoring System) performance through assessment of system logs, monitoring reports, and maintenance program. Develop corrective measures to improve system operational efficiency.

Provide technical assistance to site operating groups through investigations, equipment assessments, and design support.

Develop equipment/systems preventative maintenance plans including the coordination of annual contract services, ordering of replacement components/parts, and schedule coordination.

Management of building and utility control systems to ensure response to critical alarms in compliance with Maintenance and Quality Procedures. Evaluate trends and establish corrective actions to avoid repeat events.

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Bachelor in electricity & automation or related Engineering degree.

Essential Experience:

Minimum of 5 years of experience in automation system within pharmaceutical or medical device industries. Or at least 8 years of industry experience in pharmaceutical, medical device, healthcare, or food industries.

Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding technical documentation in English.

Solid experience in manufacturing industry and support equipment is essential; Working knowledge of process control systems is required.

Technical knowledge regarding the design, operation, preventative maintenance and trouble-shooting of site utilities is required.

Solid experience in Biopharma/Pharma manufacturing and support equipment is essential; Working knowledge of process control systems, building management and utility control systems (expertise with PLC hardware and SCADA computer systems) is required.

Essential Functions of the Job:

Write and publish internal newsletter to a quality standard that it may also be proudly shared with external parties (e.g. investors, customers);

Support other managers to maintain current promotional materials for their departments (e.g. posters for clients to view, current improvement initiatives and success stories);

Conceive, plan, and execute corporate events;

Identify and advocate for Corporate Social Responsibility initiatives that align the interests between  corporate with its staff and our community;

Update and expand potential client list;

Prepare Proposals for services with support from staff in operations and commercial departments;

Set up meetings with customers, deliver sales pitches, and negotiate service contracts;

Conduct sales negotiations with customers to achieve a profitable return for the Company;

Track and regularly report key sales performance indicators related to pipeline and meet income targets;

Attend tradeshows and conferences;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

BSc (preferably Biology or Chemistry) or related life sciences degree.

Essential Experience:

Minimum 2~3 years of business development experience focused on biopharmaceutical industry;

Proficiency in both written and spoken English is highly desired;

Proficient at MS Office software.

Essential Functions of the Job:

Responsible for coordination of multi-disciplinary team to achieve project goals, including timeline, budget and deliverables;

Together with internal project team, set and monitor the project plan including decision gate and milestones as well as generate project updates for client;

Prepare and hold project meetings including issuing of agenda, action items and meeting minutes;

Responsible for client relationship management and ensure client satisfaction throughout the life of the project execution;

Maintain effective, collaborative, and frequent interactions with other departments to ensure harmonization in scientific and technical approaches;

Work with department managers to prepare commercial Proposals;

Periodically review competitor service offerings to benchmark Bioworkshops performance and recommend improvements and/or new service offerings;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Bachelor’s degree or above in Biochemistry, Biochemical Engineering, Bioprocessing or related field.

Essential Experience:

Minimum of 7 years responsibility in pharmaceutical industry;

Sound knowledge in biologics CMC development;

Previous experience in project management to deliver investigational medicinal products (IMP) and/or dual IND filing in China, USA or Europe;

Able to manage a number of projects simultaneously.

Essential Functions of the Job:

Assist process development group to meet project timeline and departmental goals;

Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method;

Familiar with HPLC/CE method validation in release inspection, and write method validation report after method validation;

Prepare qualified samples to ensure the smooth operation of pre-clinical；

Draft the original experiment record and filing documents for IND;

Take responsibility of the general operation of the protein Analytical laboratory facilities;

Assist superior to complete other work if needed.

Education Required:

Major in bioscience or related field;

Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.

Essential Experience:

BS degree with a minimum of 0~3 years and MS degree with a minimum of 0~2 years of large Biomolecule analytical experience;

Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing;

Project management of CMC filing for US, EU, and China IND/CTA;

Familiar with office software and proficient in reading professional English;

Project management capability.

Essential Functions of the Job:

Provide input into annual operating plans;

Develop and grow a database of potential clients for Bioworkshops service offering;

Establish and operate a procedure for quantifying and prioritizing potential clients and their projects;

Support marketing and branding functions to present services that expand a business brand;

Work with company staff from operation and commercial departments to prepare winning proposals;

Identify, quantify, and prioritize opportunities for increasing Bioworkshops service offering and maximize returns;

Maintain current awareness of biologics CDMO market by online research, using targeting market surveys, and engaging with potential customers;

Prepare appealing and persuasive presentations, directed at potential customers;

Related to pipeline and meeting income targets;

Education Required:

Bachelor degree related to Life Science.

Essential Experience:

Minimum of 7 years responsibility in business development function;

At least 4 years of business development experience focused on biopharmaceutical industry;

Previous responsibility for coordinating execution of business-to-business service agreements for supply of biological products;

Previous experience in writing reports, SOPs, and forms related to business development and sales performance;

Strong understanding of biologics product development, production, and testing with focus on clinical trial materials;

Established network of industry contacts related to clinical MAb development in China and/or internationally.