SERACH RESULTS FOR" Manufacturing "
safetyHealthEnvironmentManagementManufacturing operations shall be in compliance with the legal requirements of Safety, Health, and Environment. All domestic legal requirements shall be satisfied while the international rules and regulations shall be adhered to, as applicable. CEO President,Dr. Tae Han Kim Safety Preventing Accidents Continuous Improvement in the Safety Management System (PDCA) Process Risk AssessmentWe prevent accidents such as fire, explosion, and leaks by managing potential hazards and operational problems that are analyzed regularly based on the risks of the process. Management Work RiskWe carry out voluntary preliminary inspections and safety management systems through work permit systems for dangerous work by analyzing the risk of each work situation. Work MonitoringWe consistently monitor our business sites to keep them safe by constantly checking and improving the production sites and laboratories. Annual Safety Evaluation of Each DepartmentWe practice evaluation systems for the continuous improvement by comprehensively reviewing the safety management status of each division in terms of safety, hygiene, environment, and chemical substances periodically. Identification of Potential RiskIdentification of Potential RiskWe have established a health and safety culture in the organization for which all of our employees participate by taking the appropriate measures of reporting and identifying any potential risks, analyzing the causes and establishing the measures to prevent a recurrence. Emergency Response DrillWe have established various scenarios and conduct annual emergency response training in order to efficiently and systematically respond to the emergency circumstances of human and material resources. Safety Culture Annual Assessment of the Safety Culture (Assessment → Analysis → SHE Annual Plan) Emphasis on Safety Culture from the managementAll our employees strive to strengthen and cultivate a health and safety culture along with the continuous care and support of the management. Safety Awareness TrainingWe annually conduct and analyze safety culture evaluations, and associate the measures of vulnerabilities found with attitude enhancement training to share with all employees. Safety CampaignWe confirm that all employees are aware of the importance of contributing to a health and safety culture by not only implementing legal issues but also organizing a safety campaign on traffic and public security to establish a better safety culture. Safety CommunicationWe are strengthening our organizational communication by exchanging large and small safety issues through monthly health and safety meetings, safety talks & TBM. Safety ChampionWe motivate our employees to display a keen interest in safety issues by selecting a Safety Champion. The Safety Champion is selected across the departments, and these individuals who have achieved excellent safety standards will be awarded. Safety EventWe motivate our employees to display a keen interest in safety issues by selecting a Safety Champion. The Safety Champion is selected across the departments, and these individuals who have achieved excellent safety standards will be awarded. Health Health Enhancement for Our Employees Health Check-Up and Follow-UpWe conduct annual health check-ups on the health status of our employees and conduct any necessary follow-up management through the affiliated hospitals. Musculoskeletal System Harmful Factors ManagementWe conduct research on the harmful factors of musculoskeletal disorders and deliver a program for the prevention of musculoskeletal disorders to achieve a better working environment. Operation of Mental Health ClinicWe operate a variety of programs for mental health to prevent any mental health issues and mental health related accidents occurring for our valued employees. Industrial Hygiene Management Work Environment AssessmentWe continue to make the essential efforts to create healthy workplaces by measuring the exposure levels of harmful facto
leadershipmanufacturing are decreasing, and new innovative types of medicines are being developed to help millions suffering from devastating diseases. Our vision is to become the most competitive CDMO and offer a significant increase in available capacity, quality, and innovation. This will allow our client partners to provide valuable biological medicines to their patients both cost-effectively and on time. To realize this vision, we have built a unique continual processing platform for the manufacturing of biopharmaceutical products with quality and utional excellence in compliance with global regulatory bodies including the FDA, EMA, PMDA, and MFDS. We pride ourselves in delivering superior customer satisfaction through better quality, superior service, and compliance. Based on Samsung’s principles of Quality First and a track record for excellence in plant design, construction, operations, and ution, our competitiveness surpasses that of our rivals without sacrificing quality, regulatory compliance, or our business ethics. While continuing to implement current industry best practices, we strive together with our clients to set higher standards for biopharmaceutical manufacturing. Our operations are designed to fully comply with international regulatory and cGMP requirements and are overseen by our Quality Division. Our advanced facilities are able to manufacture biological products from early development through commercial supply stages. Furthermore, our experienced people provide expertise in cell line development, culture, purification, analytical testing, aseptic filling, and packaging. Our diverse capabilities, manufacturing scale, and flexibility represent a truly integrated one-stop service that meets all our clients’ needs. We will continue expanding our facilities and capabilities to meet growing market demand. As a global company, we pledge to continue Samsung’s legacy of excellence by combining our business, manufacturing, and engineering expertise, to bring innovation and progress to today’s biopharmaceutical industry. Sincerely yours, Dr. Tae Han KimPresident & CEO, Samsung Biologics Key utives UTIVE VICE PRESIDENTKyusung Lee, Ph.D.Dr. Kyusung Lee is utive Vice President in charge of Contract Manufacturing Operation 1 of Samsung Biologics. Prior to joining Samsung in 2010, Dr. Lee held various leadership positions in biopharmaceutical companies in the U.S. Dr. Lee began his career with Miller Brewing Company in 1991 as a biochemical engineer. He led the production team for Amoco BioProducts Corporation from 1992 to 1995 and was responsible for the technology transfer of a full scale biotechnology process, after which Dr. Lee moved to Merck & Co. During his tenure at Merck from 1995 to 2005, Dr. Lee participated in the design, construction, start-up, technology transfer, and commercial operation of biologics and pharmaceutical manufacturing facilities. From 2005 to 2010, Dr. Lee assumed responsibilities for technology transfer activities for Bristol-Myers Squibb Co.'s CMO programs. Dr. Lee holds a doctoral degree in chemical engineering from Purdue University. UTIVE VICE PRESIDENTJohn RimJohn Rim is utive Vice President in charge of Contract Manufacturing Operations 2 comprising the newest plant within Samsung Biologics. Prior to joining Samsung Biologics in 2015, Mr. Park held various technical and operational positions, as well as business development management leadership positions in biopharmaceutical companies in the U.S. Mr. Park began his career in 1989 with ALZA Corporation, a subsidiary of J & J, as a chemical engineer where he participated and led process and product development, technology transfer, validation and commercialization of several OROS products. He then worked in Technical & Alliance Management at Watson Pharmaceuticals. Transitioning to Merck as a Change Agent/Six Sigma Project Manager, Mr. Park then managed the Operational Excellence projects related to process improvements, cost savings and qua
historyManufacturing Partnership with CytoDynMar. 2019 Development Partnership with EutilexOCT. 2018 AEO CertificationOCT. 2018 Plant 3 cGMP ReadyJul. 2018 First DP Approval by FDAJul. 2018 Manufacturing Partnership with UCBJUN. 2018 Development Partnership with GI InnovationJUN. 2018 First Approval of Plant 1 by Health CanadaApl. 2018 ISO 22301 Certification (BCMS)DEC. 2017 First Approval of Plant 2 by EMANOV. 2017 Plant 3 Mechanical CompletionOCT. 2017 MOU for Strategic Alliance with MerckSEP. 2017 First Approval of Plant 2 by FDAJUL. 2017 Manufacturing Partnership with Sun PharmaMAY. 2017 First Approval of Plant 1 by PMDASamsung’s Innovative DesignPLANT 2 The Largest Single Plant5X Scale (DS 15,000L + DP Fill/Finish)Total Capacity - 152,000L (10x15,000L / 2x1,000L)Construction - 29 months to cGMP ready2016NOV. 2016 Samsung Biologics IPO on KOSPINOV. 2016 First Approval of Plant 1 by EMAFED. 2016 Plant 2 DS cGMP ReadyNOV. 2015 First Approval of Plant 1 by FDANOV. 2015 Plant 3 Construction StartedOCT. 2015 Plant 1 PLI ApprovalFEB. 2015 Plant 2 mechanical CompletionAPR. 2014 Manufacturing Partnership with BMS2011-2013Standard DesignPLANT 1 Industry StandardIndustry Average Scale (DS 30,000L + DP Fill/Finish)Total Capacity - 30,000L (6x5,000L)Construction - 25 months to cGMP ready2013OCT. 2013 Manufacturing Partnership with RocheSEP. 2013 Plant 2 Construction StartedAug. 2013 Plant 1 DP cGMP ReadyJul. 2013 Manufacturing Partnership with BMS JUN. 2013 Plant 1 DS cGMP ReadyJUL. 2012 Plant 1 Mechanical CompletionMAY. 2011 Plant 1 Construction StartedAPR. 2011 Foundation of Samsung Biologics
Drug ProductManufacturing. Samsung Biologics’ dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production. Global Health Authority approvals for Plant 1 by the FDA, EMA, NAVISA, COFERIS, MOIT and TITICK. FILL & FINISHSamsung Biologics DevelopmentSamsung Biologics provides Formulation services for Drug Product Fill and Finish. Formulations can be completed from both single use systems or hard pipe systems. Additionally, we provide optimized type formulations while securing stability and effectiveness for the customer within the time they need. We are also fulfilling customer satisfaction through development service that considers even the permitted articles following the relevant formulations. Core EquipmentSmall scale lyoDown Flow BoothDSCKarl FisherFreeze Dryer MicroscopeManual Filler (Peristaltic Type)Specialized CapabilityBiopharmaceuticalsMonoclonal antibodiesFusion proteinsBispecific antibodiesPackaging (Vials)ProteinsPeptidesFormulation process optimization based on QbDFormulation DevelopmentFormulation DevelopmentThawEquipmentFreeze/Thaw skid for cryovesselsFreeze/Thaw skid for cryobagsCapacity/CapabilityControlled freezing and thawingMax. capacity : 1 tank per stationTemperature range : -70ºC to 40ºCThawThawFormulationPlant 1EquipmentExcipient and formulation vesselsCapacity/CapabilityExcipient vessel capacity : 20L to 3,000LFormulation vessel capacity : 20L to 1,500LpH and temperature controlWeight controlCIP/SIP of excipient and formulation vesselsSingle use solutions capabilitiesPlant 2EquipmentExcipient and formulation vesselsCapacity/CapabilityExcipient vessel capacity : 200L to 2,000LFormulation vessel capacity : 200L to 2,500LpH and temperature controlWeight controlCIP/SIP of excipient and formulation vesselsSingle use solutions capabilitiesVial Preparation and FillingPlant 1EquipmentWashing, depyrogenation, vial fillingStoppering, capping, transfer to lyoCapacity/CapabilityActive RABSFilling rate : up to 12,000 vials/hrFilling operation range : 0.1 ~ 100mlPump types : piston and peristalticCIP/SIP of vial filling machine2mL to 50mL vial sizeGRADE A over sealingAdaptable process to include single use or fixed systemsInline IPC capability (non-destructive testing)Plant 2EquipmentWashing, depyrogenation, vial fillingStoppering, cappingCapacity/CapabilityActive RABS, Piston & Peristatic PumpMax. capacity : 300 vials/min (based on 10ml vial)Filling operation range : 0.1ml to 100ml100% weight check systemCIP/SIP of vial filling machineGRADE A over sealing (enclosed RABS)Adaptable process to include single use or fixed systemsVial Preparation and FillingVial Preparation and FillingInspectionManual InspectionEquipmentManual inspection BoothsCapacity/CapabilityComprehensive visual inspection programOperators' manual inspection qualificationProduct type : liquid, high viscosity, and lyophilizedDefect classification library and qualification programs developed for all product typesVial cap printing capabilities availableSemi Automatic and Automated InspectionEquipmentAutomated inspection lineCapacity/CapabilityLine speed : 12,000 vials/hr (20R vial)Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc.InspectionInspectionPackagingEquipmentManual bulk packagingCapacity/CapabilityLine speed : 18,000 vials/hr (30mm diameter vial)Pakaging type : labeler, cartoner, overwrapperLaser carton print systemAutomatic weight check unit between cartoner and overwrapperPackagingLYOPHILIZATIONEquipmentTwo(2) lyophilizersCapacity/CapabilityMax. loading capacity : 32,000 vials (10ml) per lyoIce load capacity : 300kgShelf area : 16.7 ㎡Automatic loading and unloading system with RABSLyophilizationLyophilizationLyophilization Cycle Development and Commercial ScalabilityLyophilized product design Product characterization Thermal characterization of product (Tg, Tg’, Teu,Tc)Characterization of freezing step
DevelopmentManufacturingcGMP DS Stability Study6.cGMP DP ManufacturingcGMP DP Stability Study7. IND Filing Support Timeline ? Speed to IND Timeline of Cell Line development to DS productionYear Month Construction CLD to IND Filing : ~ 18 MonthCLD to DS Production : ~ 12 Month DS to IND Filing Semi-fast -2M Vector Construction -1M Year 1 1M Cell Line Development 2M 3M 4M Process Development- Upstream- Downstream- Formulation- Anaytical Method 5M 6M Non GMP DS (Tox.)- Non GMP DS Stability- Non GMP DP Stability- Interim Reference Stadard Qualification 7M 8M Analytical Method Transfer to QC 9M 10M Virus Clearance Study 11M cGMP Clinical DS- Lot Release- cGMP DS Stability 12M Year 2 13M GMP DS Characterization 14M 15M cGMP DP- Lot Release- cGMP DS Stability Regulatory Documentation16M 17M 18M CELL LINE DEVELOPMENT Right Start, and Better Quality At Samsung Biologics, we provide high-quality mammalian cell line development for a variety of antibodies and proteins using the CHOZN platform. Along with Samsung Biologics’ specialized cell line development know-how, our experts have extensive experience of molecule development including difficult-to-handle products and are capable of delivering robust, high-yield single cell clone to our clients. Cell Line Development Platform Process 1,2 : 1st screeing - Screen and rank potential clones into 5 pools3 : Single Cell Cloning - Support monoclonial process4 : 2nd screening - Screen and rank of top 10 subclones6 : Top 3 RCB - Screen and rank of top 10 subclones6 : Stability Study - Assess stable maintanance of titer and product qualtiy6.5 : Fed-Batch - Assess stable maintanance of titer and product qualtiy UPSTREAM PROCESS DEVELOPMENT Samsung Biologics has a highly skillful development R&D team with dedicated focus on advanced development services. With our sophisticated platform development process, our team provides Process Development services utilizing Quality by Design (QbD) approach. Upstream Process Development Flow Molecule information / cell bank transferBasal Media Screening in shake flaskFeed Media Screening in shake flaskProcess Optimization In Ambr 15™Process verification run in 2L STR DOWNSTREAM PROCESS DEVELOPMENT Samsung Biologics offers our established downstream process development platform developed by our highly experienced scientists. Together with our insights in bioprocess and manufacturing, we are capable of developing a customized, optimal and efficient process resulting in high yield manufacture in a timely manner. Downstream Process Development Flow Preparation for DSP Development Virus Inactivation Process Development Filter Preocess Development Process verification run in AKRA ANALYTICAL METHOD DEVELOPMENT Analytical Method Development Analytical Method Development - Quantity- Impurities- Identity- Potency- Glycan profile- Excipient- Purity & Heterogeneity Extended characterization & comparability studies - Primary strucure- High order structure- Biological activity Analytical Support - In-process analysis for USP and DSP development CMP Facilities Small Scale Manufacturing ? CMP 1 & CMP 2 As the world’s largest CDMO, we offer multiple cGMP manufacturing facilities to meet the diverse scales of our clients’ demands. The CMP Facility has the same best-in-class characteristics and equipment as our large-scale capacity. CMP1-STAINLESS STEEL BIOREACTORS Flask CultureBrx 1x20(N-1) - 20L (nominal volume) wave bioreactorBrx 1x30(N-1) - 40L (w.v) seed bioreactorBrx 1x40(N-1) - 200L (w.v) seed bioreactorBrx 1xY0(N) - 1,000L (w.v) production bioreactor CMP2-SINGLE-USE BIOREACTORS Flask Culture20L - (nominal volume) Single use bioreactor50L (w.v) - seed bioreactor200L (w.v) - seed bioreactor1,000L (w.v) - producti
QUALITY CONTROLManufacturing, Quality & Compliance, and Analytical Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes. Analytical Testing Capabilities Across the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release as well as stability. Our QC team is capable of performing analytical test method transfers from client laboratories and performing the required method validation, qualification, or verification, according to the ICH Q2 (R1) guidelines in order to satisfy the requirements of the U.S. FDA, EMA, and PMDA. Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of: ChemicalTesting 1. pH, Osmolality, Protein Content (A280), Appearance2. Water content3. Identification by FT-IR4. Impurity / Purity by HPLC BiochemicalTesting 1. Enzyme-Linked Immunosorbent Assay (ELISA)2. Polymerase Chain Reaction (PCR)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based Assays MicrobiologicalTesting 1. Microbial Limit (Bioburden)2. Endotoxin3. Microbial Identification4. Sterility Stability Program Capabilities We maintain a controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and the accelerated conditions of temperature and/or light. Environmental and Clean Utility Monitoring Through our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that the controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable particulates, Settle Plates, and Contact Plates. Clean Utilities Monitoring includes the testing for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.
CEO Letter to Shareholders Dear Shareholders of Samsung Biologics: On November 14, the Securities and Futures Commission (“SFC”) announced the final result of its audit on our accounting in respect of our associate, Samsung Bioepis (“Bioepis”). In this regard, we will explain the progress of this issue and our position on the result of the measure taken by the SFC. ?Samsung Biologics (the “Company”) has been audited by the Financial Supervisory Service (“FSS”) since April 2017 as to whether the accounting was properly treated in the Company’s financial statements in respect of Bioepis, a joint venture between the Company and Biogen in the U.S., and the FSS disclosed the result of the audit to the media in early May. ? After numerous meetings of the audit committee and the SFC, the SFC announced the following results of the measure on July 12, 2018: among the alleged accounting violations of the Company, (i) “gross negligence” for failure to record notes regarding call options granted to Biogen in respect of shares in Bioepis to the auditors’ report for 2012 and 2013; (ii) “willful misconduct” for insufficient record of notes to the auditors’ report for 2014; and (iii) order for re-audit by the FSS with respect to the discretionary evaluation of the investment in shares through an inappropriate change of the accounting standards for 2015. ?In its announcement of the decision on re-audit on November 14, the SFC concluded that the Company’s treatment of Bioepis as a consolidated subsidiary as opposed to an associate under the equity method from 2012 to 2014, which was not deemed a violation in July, was to be deemed “negligence” for 2012 to 2013 and “gross negligence” for 2014. It also announced that the Company’s unjust discretionary evaluation of investment in shares for 2015 and failure to retroactively apply the amended accounting standards to the financial statements after 2012 would be deemed “willful misconduct.” ? Accordingly, the following measures were taken against the Company: i) prosecution against the Company and its representative director; ii) recommendation of dismissal of the Company’s representative director (CEO) and the responsible officer (CFO); iii) compulsory designation of external auditors for 3 years; iv) an order of a corrective measure (retrospective restatement of financial statements); and v) imposition of an administrative fine worth KRW 8 billion for “willful misconduct.” ?According to the KOSPI Listing Regulation, in case of any prosecution for violations of the accounting standards in the amount equal to or greater than 2.5% of the shareholders’ equity (for a large-scale corporation), a listing maintenance review event is triggered and such review must be conducted immediately after suspension of trading activities. Therefore, the trading of the Company’s shares has been suspended since the SFC’s announcement on its resolution after market closing on November 14. ?We deeply regret the findings of the SFC as we are confident that our accounting treatment has been proper under the K-IFRS. As such, we filed an administrative lawsuit against the SFC on October 8 regarding the 1st audit result and another administrative lawsuit against the SFC on November 27 regarding the 2nd audit result. Through these lawsuits, the Company aims to have the legality of its accounting treatment recognized. To prevent the administrative dispositions from taking effect, the Company applied for an order to stay the dispositions on restatement of financial statements, recommendation of dismissal of CEO and CFO, designati
manufacturing. The Beacon platform is designed to rapidly screen thousands of clones simultaneously while measuring valuable parameters, such as growth rate or IgG production. The rich characteristic profiles that result for each clone help to quickly inform selection of stable and high-producing cell lines. “Samsung Biologics is known as one of the world’s top full-featured CDMOs that delivers quality biologics to market quickly and safely,” said John Proctor, Senior VP of Antibody Therapeutics, Berkeley Lights. “At Berkeley Lights, we are dedicated to gaining deep cell insights and to finding the best cells. We are excited to provide Samsung Biologics with the technology necessary to accelerate cell line development for their customers.” About Samsung Biologics: Winning the CMO Leadership Awards for six consecutive years since 2013, Samsung Biologics has proven its expertise and reliability with a continued strength in high-quality product manufacturing and cost-effective services. With its ability to address CDO, sCMO, CMO, DP, and CRO needs all from a single site, Samsung Biologics is a qualified CDMO, is repeatedly chosen by clients and is uniquely able to support the development and manufacturing of both large and small scale at every stage of the process while meeting the evolving needs of biopharma/pharma companies worldwide. About Berkeley LightsBerkeley Lights, Inc. is a company that develops and commercializes workflows and processes to find the best cells. By operating at the intersection of biology, technology, and information, our workflows accelerate the design, discovery, development, and delivery of cell-based products. Our technology platform* automates the manipulation, analysis, and selection of individual cells, allowing scalability and deep cell insights. Berkeley Lights enables the rapid deployment of biology for the production of sustainable and scalable sources of food, therapies, and energy. For more information, visit www.berkeleylights.com. *The Beacon optofluidic platform is For Research Use Only. Not for use in diagnostic procedures.
manufacturing organization (CDMO) located in Songdo, South Korea. Founded in 2011, Samsung Biologics has the largest total plant cell culture capacity in the world from a single location: 364,000 L. The company employs more than 2500 employees including 100+ global expats from 12 countries.To discuss the company’s vision for modernizing manufacturing quality, I sat down with James Choi, VP and CIO, Samsung Biologics, at the 2019 Veeva R&D Summit.To date, the company has had a 100% drug substance batch success rate. It has also undergone more than 20 regulatory inspections and 29 approvals in 4 years. Managing Content on Samsung’s Shop FloorCustom applications and paper binders make it difficult to find, update, and track work instructions and procedures, as well as to verify that the right versions are being used.When Samsung Biologics was looking for a way to deliver the right content to the right station for a connected shop floor, it partnered with Veeva to develop Vault Station Manager, an easy-to-use mobile application in the Veeva Vault Quality Suite.Vault Station Manager provides manufacturing operators up-to-date content directly on the manufacturing floor. It delivers documents and videos, including critical work instructions and procedures, from Veeva Vault QualityDocs to tablets located at shop floor stations.Vault Station Manager allows Samsung Biologics to connect to the shop floor making manufacturing operations more agile and adaptable to changing business requirements with greater velocity.“It’s challenging,” revealed Choi “to manage and maintain information on the manufacturing floor and ensure operators are working from the latest procedures. Delivering content directly to manufacturing stations through a mobile application makes it faster for teams to stay up-to-date.”With Vault Station Manager, manufacturers can increase efficiency and reduce compliance risk by keeping content current and providing operators the information they need to perform their jobs. Vault Station Manager automatically synchronizes content on station tablets and makes it available for operators, including for offline viewing. Administrators can centrally manage, distribute and track the content being used at each facility, station, or device gaining complete visibility into the documents and videos manufacturing teams are leveraging.According to Mike Jovanis, VP Vault Quality at Veeva Systems, “Veeva is modernizing manufacturing operations in life sciences with an advanced mobile application to connect the shop floor. Veeva Vault Station Manager is making it easier for operators to do their jobs and enable continuous operations across the manufacturing organization.”What’s Next for Samsung?Samsung Biologics is built on Samsung’s innovation DNA as well as its core skills in engineering and operational excellence. However, noted Choi, “We don’t implement technology for the sake of technology, we implement innovation that drives business value based on a unified IT vision approach.” The company’s IT directional focus is guided by three value drivers:Provide quality and efficiency of development and manufacturing servicesDeliver blockbuster scalability and operational resilienceBuild partnership value and trustTo drive business value based on its unified IT vision, Samsung Biologics is evaluating the use of technologies such as Internet of Things (IoT), Block chain, Cloud BI and Paperless validation.
manufacturing and cost-effective services. With its ability to address clients’ needs all from a single site, Samsung Biologics is a qualified CDMO as repeatedly chosen by clients and is uniquely able to support the development and manufacturing of both large and small scale at every stage of the process while meeting the evolving needs of biopharma/pharma companies worldwide.
ManufacturingQualityEngineeringManagement Support ManufacturingManufacturingCell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial Management and ValidationDistribution ManagementValidation QualityQuality ControlQuality Assurance EngineeringInfra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Business DevelopmentBusiness DevelopmentBD PlanningCorporate Business OperationPlanningProcurementLegal & CompliancePRCorporate managementFinanceInformation TechnologyHuman resources Application MethodComplete and submit application form to the e-mail address for recruitment at Samsung Biologics. E-mail email@example.comPassing of the application procedures and employment may be cancelled if the contents of the application form are found to be false. ※ Download Application Form REGISTER IN TALENT POOL Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
ManufacturingQualityEngineeringManagement Support ManufacturingManufacturingCell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial Management and ValidationDistribution ManagementValidation QualityQuality ControlQuality Assurance EngineeringInfra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Business DevelopmentBusiness DevelopmentBD PlanningCorporate Business OperationPlanningProcurementLegal & CompliancePRCorporate managementFinanceInformation TechnologyHuman resources Application MethodComplete and submit application form to the e-mail address for recruitment at Samsung Biologics. E-mail firstname.lastname@example.orgPassing of the application procedures and employment may be cancelled if the contents of the application form are found to be false. REGISTER IN TALENT POOL Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
MANUFACTURING SCIENCE AND TECHNOLOGY TEAM Thomas Gervais Video Play Layerpopup“ I came here looking for both professional and personal experience, and Samsung Biologics has exceeded those expectations. ”ASEPTIC FILLING TEAM Adam Gibbons WHAT WE VALUE Bio Model Employee Globally-minded employees who maximize their performance with professionalism, and enhance their abilities by pursuing collective intelligence through the best collaboration. Bio Behavior ProfessionalismResponsibility & OwnershipEnthusiasmutionTeamwork WORKING WITH US Career Development We support the continuous development of our employees. Systematic training opportunities to reach common values and cultivate expertise. ValueLeadershipGlobalExpertise More Training Opportunities BenefitsStriving for successful and happy employees Maintaining the right balance between work and social life is encouraged through the pursuit of healthy activities and relaxation. Health & Wellness Health & WellnessService Areas & Environment Service Areas & EnvironmentFamily Support Family Support Diversity & Inclusion As a young company, we continue to grow with our people. We are a family friendly company that embraces diversity and inclusion. Diversity & InclusionDiversity & Inclusion Samsung Biologics Business Model Business DevelopmentCDOPM, Cell Culture, MSAT, Puification, Material Management, Fill & FinishQuality / ValidationCROHR Finance Information Technology Planning Procurement Logal & Compliance How to Apply A Step-by-Step Guide to the Job Application Process ExperienceLevel1ExperienceType2EmploymentProcess3 Experienced New Hires Interns Next FAQ Overseas ExperiencedDomestic ExperiencedNew & Interns Overseas Experienced Would Master's degree or Ph.D be considered as past work experience?In accordance with internal policy, we do acknowledge Master's and Ph.D as work experience. Details will be shared during recruitment process. My past professional experience does not directly relate to the position I'm applying for. Would the respective experience be acknowledged?Samsung Biologics acknowledges past experience based on the relevance to the job. Unfortunately, past experience with no direct relevance to the role being considered for will not be acknowledged. When do I submit necessary documents?We ask for the applicant to prepare necessary document upon invitation for utive Interview. The necessary documents will be notified beforehand. How would I know if a hiring decision has been made? (Would separate notification be sent to those that did not pass?)Samsung Biologics sends out hiring decision via email for all results. If I'm currently working outside of Korea, how will the interview procedures take place?After initial CV/Resume screening, we will conduct phone interviews. Afterwards, we will invite the applicant to Samsung Biologics Songdo Campus for an Onsite Interview. Domestic Experienced How can an applicant with past experience submit an application for employment?Recruitment of staff with past experience is conducted through individual resume submissions via email. Please refer to the recruitment procedures for more details.? If I am working in an overseas country, how are the interviews conducted?Following the documentary review, we will conduct a telephone interview. If you successfully pass this, a final on-site interview will be carried out.? When is the recruitment period for staff with previous experience held?Samsung Biologics is recruiting new staff with past experience on demand without publicly announcing recruitment. If you submit your resume to our recruitment personnel in charge, we will review it and contact you individually.? Does the company provide a shuttle bus service or staff accommodation if I have difficulties with transportation in reporting to work?We are currently providing a shuttle bus service for reporting to and returning home for the residents of Seoul and Gyeonggi regions.If you have no place to stay in Korea or have diffi
Samsung Biologics (hereinafter, the “Company”) values users’ personal information, complies with statutory obligation s on protection of personal information such as the Act on Promotion of Information and Communication Network Utilization and Information Protection, etc. and the Act on Protection of Personal Information, and has created a Policy to Handle (Process) Personal Information to protect the users’ right and interest to the maximum extent possible.
Through the Policy to Handle (Process) Personal Information, the Company publicizes its operations on personal information treatment (processing) with particulars such as the types of personal information collected from the users and the purpose of processing such information, the time limit for processing and holding in possession, users’ method to exercise their rights, measures to procure the security, and so on.
Whenever there is a change in the Policy to Handle (Process) Personal Information, including updating, deleting, or adding its contents, whether resulting from any amendment to the relevant statutory sources or the administrative policy or change in the Company’s internal policy, we will post the change on our website at www.samsungbiologics. com so as to keep the users updated.
The Company’s Policy to Handle (Proce ss) Personal Information contains the following:
The Company collects personal information for the following purposes. The pfi will not be used for any other purpose and whenever it is necessary to change the purpose, we will comply with the statutory requirements such as obtaining users’ consents in advance.
Review and reply to the inquiries from users
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If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements.
If it is likely to jeopardize a person’s life or body or unjustly infringe a person’s property or other interests.
The Company is operating cookies that regularly stores and locates users’ information.
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in handling users’personal information, the Company endeavors to keep the personal information from being lost, stolen, revealed, tampered or damaged. To this end, the following technical and managerial actions are taken.
The Company implements its own internal management plan to secure safety in processing the personal information.
The Company is operating an internal organization dedicated to personal information protection to monitor the status of compliance with the personal information protective requirements and the responsible staff’s duty performance and takes corrective measures when any irregularity is found.
Installation and operation of access restriction device Using the intrusion blocking system, the Company controls any unauthorized access from outside and endeavors to procure all the technological system to the maximum extent feasible in order to secure systematic security.
Minimized designation of personal information processors and education The Company minimizes designation of personal information processors and implements internal and/or outsourced education on a regular basis. Personal information processors’ duty handover is conducted with the security fully maintained and their responsibilities for any personal information accident are clearly defined even after they have left the Company.
Restrictions on access to personal information The Company places restrictions on access to personal information through granting, changing or revoking the right to access to database system that processes personal information. We also record the history of granting, changing or revoking the right, which are retained for our records for at least three years.
The personal information of users is protected by the password and the file and transmission data are encrypted or stored by using file lock function. More important data are protected through certain separate security measures.
The Company has adopted security devices that enable safe transmission of personal information on the network using encryption algorithm.
To safeguard personal information from leak or loss by hackers or computer viruses, the Company has installed a security program and conducts periodic updating and reviewing.
For unmistakable security operation, every server is installed with intrusion blocking system as a means to block outsider intrusion by hacking as well as a system to analyze vulnerability.
To protect users’personal information and handle personal information-related customer complaint, the Company has appointed a personal information manager and processor. Any inquiry related to personal information protection and management should be directed to the personal information processor for instant and adequate reply.
Division: General Affairs Security Part, Personnel Management Team
Any user seeking to relief from personal information infringement may apply for resolution or consultation to Personal Information Dispute Mediation Committee, Korea Internet and Security Agency (Personal Information Grievance Center). In addition, users may contact the following institutions to be consulted on personal information infringement cases.
Personal Information Dispute Mediation Committee (118)
Korea Internet and Security Agency (Personal Information Grievance Center)(www.kopico.or.kr/1336)
Information Protection Mark Verification Committee (http://eprivacy.or.kr/02-580-0533~4)
Internet Crime Investigation Center of the Supreme Prosecutors’ Office
Cyber Police Agency (www.police.go.kr/1566-0112)
Personal information Protection Committee (http://privacy.kisa.or.kr/kor/main.jsp)/02-2180-3000)
When this ‘Policy to Handle (Process) Personal Information’ needs to be changed to reflect the change in statutory sources or government policies, we will put such change in public notice through an advisory statement and a separate window on the website.
Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.