[Yuhan USA] Business Development Manager – San Diego, CA/ Boston, MA
Position: Business Development Manager
Work location: San Diego, California / Boston, Massachusetts
Responsibilities:
• Build relationships with potential business partners, outside counsel, and other key external parties
• Attend conferences, seminars, meetings, and industry events as a representative of Yuhan USA
• Act as a liaison between external partners and internal R&D team; facilitate meetings in regards to product development, R&D collaboration, and other issues
• Perform research and analysis for focused therapeutic areas; report to the management and R&D department
Qualifications:
- Required
• MS in Life Sciences, Pharmacy, Biology, or related discipline
• Relevant biotech or pharmaceutical industry experience
• Fluent in English - Preferred
• MBA, Ph.D., or other advanced degrees
• Experiences in drug research, development, and commercialization activities - Others
• Excellent interpersonal, networking, and communication skills
• Fluent in Korean (Optional)
Contact Information: info@yuhan-usa.com
[Samsung Biologics America] Cell Line Development Scientist – South San Francisco
Samsung Biologics America is recruiting a Cell Line Development Scientist to join our growing R&D team in South San Francisco. Samsung Biologics is a global CDMO leader (Contract Development and Manufacturing Organization) and an award-winning partner of biologics development and manufacturing.
We provide end-to-end solutions from cell line development, regulatory support, small & large scale manufacturing, drug product manufacturing, and laboratory testing services for the biopharmaceutical industry to meet the needs of the global healthcare industry.
Samsung Biologics America offers tremendous growth opportunities to our employees.
Key Responsibilities
• The primary role is to generate biologics producing CHO cell lines suitable for cGMP manufacturing within project timelines
• Prepares cell line development and characterization reports as supporting documents for client projects
• Prepares project data for external clients and functions as a subject matter expert. The scientist is expected to participate in project meetings
• Participates or leads process optimization of current protocols and evaluates new technologies to improve platform technology and processes
• Detail-oriented laboratory skills with the ability to present scientific data
• Maintains good laboratory records and contributes to internal and external scientific discussions
Qualifications
[Education]
• Minimum BS degree in biology, microbiology, or other bio-pharmaceutical-related majors
[Required Experience]
• Direct experience in CHO cell line development, optimization, and characterization is essential
• Understanding of upstream process development and cell banking
• Experience in gene manipulation and analytical skills is a plus
[Knowledge/Skills]
• Ability to work with global customer base supporting cell line development with molecules ranging with a high degree of complexity
• Knowledge in biological drug production and process development
• Competency in Microsoft Office suite
• Communication skills to share scientific data with clients
• A strong sense of team play is a must
For more information, please contact Dr. JaeB Kim (jaeb.kim@samsung.com)
7th KAPAL On-Air Webinar (June 24, 2021, 9:00 – 10:30 PM EST)
2021 KAPAL–KHIDI Bio & Health Webinar Series는 한미생명과학인 협회 (KAPAL)와 KHIDI 미국지사 웨비나 시리즈입니다.
About this event
KAPAL 7th On-Air Webinar
(2021 KAPAL-KHIDI Webinar Series #2)
Title: Use of Real-World Data and Real-World Evidence in Drug Development
The 21st Century Cures Act established a program to evaluate the potential use of real-world evidence (RWE) to help to support the approval of a new indication for a drug approved and to help to support or satisfy post-approval study requirements. Accordingly, the FDA has been exploring the potential use of Real World Data (RWD) in regulatory decision making. This presentation will start with general overview of Real-World Data and Real-World Evidence in drug development and introduction to observational studies and causal inference. Th challenges with RWD/RWE will be discussed from multiple aspects including data quality, study design and statistical methods to adjust potential confounding. At the end of presentation, case studies will be presented.
About the presenter:
Joo-Yeon Lee, Ph.D.
Senior Statistical Reviewer, FDA
Joo-Yeon Lee, Ph.D. is a senior statistician of Division of Biometrics VII in the Office of Biostatistics in the Center for Drug Evaluation and Research at the FDA. She has received a B.S in statistics from Ewha Womans University, M.A and Ph.D. in Biostatistics from Brown University. Since joining FDA in 2007, Dr. Lee has been working as a pharmacometrics reviewer for new drug applications and a statistical reviewer for post-market drug safety studies. Dr. Lee has been playing a major role in many working groups on causal inference methods within the FDA. In addition, Dr. Lee has involved in FDA-led drug safety studies utilizing sentinel data and other data source such as UK Clinical Practice Research Datalink (CPRD) as a collaborator. Dr. Lee has taught the inverse probability weighting method with a case study at causal inference workshop at FDA in November 2017 and short courses at DIA/FDA Biostatistics Industry and Regulator Forum in April 2018 and ASA Biopharmaceutical section regulatory-industry statistics workshop in September 2020. Currently, Dr. Lee has main interest in the causal inference in observational studies, especially methods for sensitivity analysis for unmeasured confounder(s) and is an active member of quantitative bias analysis working group and serves as FDA statistical collaborator of FDA-funded project that aims to evaluate methods for assessment of potential for bias due to uncontrolled confounding.
7th KAPAL On-Air webinar materials
[이수앱지스] 신약본부 수시채용 – 경기도 성남시 분당구
이수앱지스 신약본부 수시채용 공고문
이수앱지스 한국 최초의 바이오 항체 치료제 개발 경험을 바탕으로 세계적 수준의 면역 항암 (Immuno-Oncology) 분야 신약개발을 목표로 연구개발에 정진하고 있습니다. 바이오 항암면역 신약개발을 함께 할 열정적이고 우수한 인재들을 아래와 같이 모시고자 합니다.
| 모집부문 | 이수앱지스 신약본부 항암 면역 프로젝트 리더 (과장, 차장급) |
| 근무지 | 경기도 성남시 분당구 글로벌알앤디센터 이수앱지스 본사 |
| 모집분야 | 바이오 신약개발 |
| 직무소개 (주요업무) | 바이오 항암면역 신약 과제 제안 및 운영면역 항암 관련 in vitro 및 in vivo 효능 평가 실무 |
| 지원자격 및 우대사항 | 면역학, 암생물, 약학, 생화학, 분자세포생물학 분야 박사 (박사 학위 후 4년 이상 연구 경험자)면역 또는 항암 관련 실무 연구 경험자 의약품 개발 경험자 우대 (예: IND 준비/제출)Global Big Pharma 경력 및 Open Innovation 경험 우대 |
| 조직소개 | 이수앱지스는 생명존중에 대한 확고한 철학을 가지고 바이오 의약품 분야에 진출하여 희귀의약품 및 항암면역 제품개발에 주력하고 있습니다. 이러한 노력은 고셔병치료제 애브서틴, 파브리병치료제 파바갈 같은 희귀질환 치료제를 연이어 출시하는 성과로 이어졌습니다. 이수앱지스는 이에 만족하지 않고 바이오 항암 면역 신약 개발을 목표로 비임상 및 임상 연구를 지속하고 있습니다. |
| 접수 기간 | 채용 완료시 까지 |
| 지원 방법 | 제출 서류 : 이력서 및 자기소개서 1부접수 방법 : 이메일 접수 (인사팀 권지원 jeewon@isu.co.kr) |
| 전형 절차 | 서류 전형 → 1차면접(화상면접 가능) → 2차면접 → 건강검진 → 채용확정 → 입사 |
| 기타 사항 | 회사 홈페이지: http://www.abxis.com문의처: 경영지원팀 권지원 대리(jeewon@isu.co.kr) |