안녕하세요.

미주지역 최대 한인 글로벌 리쿠루팅업체 HRCap (www.hrcap.com) 에서 인사드립니다.

저희 주요 고객중에 바이오제약 CMO인 “삼성바이오로직스 (SBL)” 에서 북미방문기간중에
회사발전과 함께 하실 관련분야 전문가를 영입하고자 관심있으신분들과 미팅을 하고자 합니다.
본 미팅엔 SBL HR팀 간부들께서 참석하시어, 회사의 비전과 오픈 된 포지션들에 대한 보다 자세한 정보를
들려주는 자리이오니, 관심있으신 전문가들의 많은 지원과 참여 부탁 드립니다.

삼성 바이로직스는 2011년 4월, 바이오 의약품 위탁생산(CMO)를 목적으로 설립, 이후 5년 만에 코스피 상장을
앞두고 있는 기업으로 현재 시가 총액이 10조원 이상으로 기대되고 있으며, 모기업인 삼성그룹의 적극적인
투자와 지원을 받고있는 상황입니다. 또한 현재 가동중인 제 1, 2공장에 이어, 2018년 제 3공장이 완공되면
총 36만리터의 생산능력을 갖추게 되어, 세계 최대 규모의 바이오 제약 기업의 위치를 선점하게 될 예정입니다.

저희 HRCap은 SBL 고객사의 미주지역 Primary Recruiting Agency 역할을 하고 있으며, 유첨 자료에 현재 오픈된
채용포지션이 정리되어 있사오니, 관심있으신 분은 저희에게 연락주시면 성심껏 지원하도록 하겠습니다.

HRCap 연락처는 아래와 같습니다.

. 미국연락처 : Stella Kim, T. 201-567-1500 x210, C. 201-527-5292 [email: stellakim@hrcap.com]
. 한국연락처 : Sang Shin, T. 02-2183-8900, C. 010-5430-5403 [email: sangshin@hrcap.com]

감사합니다.

//

Headquarters: 440 Sylvan Ave., Suite 120, Englewood Cliffs, NJ 07632 • TEL: (201) 567-1500
Korea Office: Hanshin-InterValley Bldg.(East Tower #818) 322 Teheran-ro, Gangnam-gu, Seoul, Korea • TEL: (02) 2183-8900
Email: hrm@hrcap.com • Website: www.hrcap.com
Samsung Bio JD
HRCap, Inc. is the largest Korean-American global executive search firm in the United States. We currently provide HR
consulting services to a robust clientele ranging from medium-sized businesses to Global Fortune 500 companies across
various industries including Biopharma, ICT (Information & Communication Technology) and Financial Services. We are the
primary recruiting agency for Samsung Bio in the U.S.
This is an exciting international expat opportunity within an emerging Global Contract Manufacturing Organization (CMO)
backed a major multinational corporation working with major Global Biopharma companies. Our client is seeking experts
in Biopharmaceutical / CMO to manage and lead manufacturing operations in many different areas. Although positions
require relocation to outside of US, this could be once in a lifetime opportunity to be part of a world leading organization,
where you can utilize the best of your abilities.
• Upstream Cell Culture Manufacturing – Manager to Director:
- Upstream mammalian cell culture manufacturing activities ranging from vial thaw, inoculum, media development,
media optimization, cell line development, and stainless steel bioreactor operations
- Upstream cell culture scale-up, Technology transfer, and Process validation activities
• Downstream Purification Manufacturing – Manager to Director:
- Downstream protein purification activities - Column chromatography, Filtration (UF, DF, TFF), Harvest and recovery
- QbD (Quality Design), Scale down studies, Process range studies, PAT, Statistical analysis, Process robustness studies,
and Six Sigma
• MS&T – Manager to Director:
- Subject Matter Expert for upstream cell culture/fermentation activities and downstream purification activities ranging
from vial thaw, inoculum, media development, media optimization, cell line development, stainless steel bioreactor
operations, chromatography, filtration and recovery
• Fill Finish – Manager to Director:
- Aseptic liquid filling of vials, Aseptic Lyophilization filling of vials, and Aseptic preparation of pre-filled syringes
• Validation – Manager to Director:
- Broad set of validation activities including facility validation, equipment validation, computer systems validation,
process validation and manufacturing support
- IQ/OQ/PQ qualification and validation activities
• Quality Control – Manager to Director:
- QC testing, methods development, and characterization including Biochemical, Chromatographic, Electrophoretic,
ELISA, Western Blot, PCR, bioassays, and Cell-based assays
- PAI readiness, BLA/ CMC filings, and FDA/EMEA audits & inspections
- cGMP compliance and GMP documentation
• Quality Assurance – Manager to Director:
- Regulatory inspections, Inspection readiness activities, and PAI
- Leadership with QA, Quality System, Quality Compliance, Document Control, Quality Engineering, Validation, and
Technical Operations capacities
Headquarters: 440 Sylvan Ave., Suite 120, Englewood Cliffs, NJ 07632 • TEL: (201) 567-1500
Korea Office: Hanshin-InterValley Bldg.(East Tower #818) 322 Teheran-ro, Gangnam-gu, Seoul, Korea • TEL: (02) 2183-8900
Email: hrm@hrcap.com • Website: www.hrcap.com
- cGMP compliance, Global regulatory agencies - FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA
• Quality and Compliance – Manager to Director:
- Leadership with R&D QA, Quality system, Quality compliance, Document control, Quality engineering, Validation, and
Technical operations capacities
- cGMP compliance, Global regulatory agencies - FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA
• Automation and Manufacturing Systems – Manager to Director:
- Key Automation Systems – DeltaV, Syncade, Werum PAS-X, Aegis Discoverant, Maximo, Velquest, and/or SAP systems
- Lean Six Sigma principles
- cGMP compliance within FDA regulated environment
• Regulatory Affairs – Manager to Director:
- Site Master Files and other regulatory documents
- Quality systems/ Quality assurance experience, SOPs within FDA/cGMP compliance
• Auditing and Compliance – Manager to Director:
- Investigation of assigned incidents/deviations and CAPAs for resolution
- Regulatory inspections, Inspection readiness activities, and PAl
- Experienced with global regulatory agencies - FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA
• Project Management – Manager to Director:
- Project on Upstream mammalian cell based cGMP biologics manufacturing, Downstream purification, Analytical
methods Technology transfer, and Process validation activities
- Quality assurance and Quality control experiences, cGMP compliance and GMP documentation
• Business Development – Manager to Director:
- Locates or proposes potential business deals contacting potential partners; discovering and exploring opportunities
thoughout the industry – contracting, in & out licensing, due diligence
• Business Development Planning – Manager to Director:
- Lead, align, and execute multiple projects in CMO perspective. Develop strategy and execute plans to support business
expansion and company growth through market intelligence, market research, financial & data analysis
• Requirements & Qualifications:
- Relevant undergraduate degree in related field
- 10+ years of relevant experiences in BioPharma (cGMP, CMO)
- Strong Scientific, Quality and Engineering experiences in the manufacturing of recombinant protein and monoclonal
antibodies
• Company will support for Relocation, Housing and Int’l school for your children