Founded in August 2009, in Nanjing, China SFDA GLP and AAALAC certified DMPK CRO company GLP...

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Transcript of Founded in August 2009, in Nanjing, China SFDA GLP and AAALAC certified DMPK CRO company GLP...

Page 1: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,
Page 2: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

Founded in August 2009, in Nanjing, China

SFDA GLP and AAALAC certified DMPK CRO

company

GLP bioanalytical support for small and macro

molecule, toxicokinetics, in vivo PK and ADME study

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Page 3: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

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Responsible for investigating metabolism pathways and

explaining metabolite structures

Manage ADME studies and ensure timely delivery of study

reports to customer

Manage a team of 10-12 scientists

Develop methods for qualitative determination and chemical

structure elucidation of metabolites from in-vitro and in-vivo

studies

Contribute to registration documentation and provide input to

questions by health authorities

Job Description

Page 4: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

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01

PhD degree in Pharmacokinetics, Drug Metabolism, or related

field

At least 10 years of industrial experience

The ability to demonstrate excellent knowledge in PK and drug

metabolism principles is a must

Working experience and proficiency with HPLC and LC/MS

instrumentation

Be familiar with laboratory techniques such as in vitro/in vivo

metabolism and PK experiments, analysis of drugs and

metabolites in biological fluids

Qualifications

Page 5: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

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02

Direct and manage Pharmacology studies in area of CV, DM and

CNS diseases in a regulatory environment

Manage a team of scientists to perform high-quality research in

compliance with the protocol, company SOPs and AAALAC

guidelines

Direct communications with sponsors, execute, and complete

testing programs that meet sponsor requirements and ensure to

deliver on-time high quality reports to clients

Job Description

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PhD or equivalent degree in pharmacology, toxicology, or related

fields, have demonstrated experience in the area of CV, DM, or

CNS diseases

At least 10 years of post-graduate work experience in related

fields, be well organized, detail-oriented, and capable handling

multiple tasks in a fast-paced growing company environment

Highly self-motivated, work in a multidisciplinary team, possess

good interpersonal skills and have excellent oral and written

communication

Qualifications

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Job Description

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As DMPK expert, perform advanced PK and PK/PD analyses and

provide result interpretation and guidance

As Study Director for GLP and non-GLP studies, provide

expertise and guidance for experimental design and facilitate the

monitoring, coordination and data collection of PK or PK/PD

studies

Ensure compliance with relevant regulatory standards (FDA,

EMEA and SFDA), as well as external and internal guidelines

(e.g. SOP’s)

Page 8: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

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Qualifications

03

PhD or equivalent degree in Pharmacokinetics, demonstrated experience in regulatory research and possess superior management and problem solving skills

≥7 years of post-graduate work experience in DMPKStrong advanced knowledge of pharmacokinetics and drug

metabolismHighly self-motivated, goal orientated, work as part of a team,

good interpersonal skills and excellent oral and written communication

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As DMPK expert, provide programs for experimental design of

biological drugs

Establish a determination method of macromolecular drugs,

including ELISA, RIA, ECLIA, and the FIA

Ensure compliance with relevant regulatory standards (FDA,

EMEA and SFDA), as well as external and internal guidelines

(e.g. SOP’s)

Job Description

Page 10: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

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Qualifications

PhD or equivalent degree in Pharmacokinetics, demonstrated

experience in regulatory research and possess superior

management and problem solving skills

At least 7 years of post-graduate work experience in biologics

Strong advanced knowledge of biologics quantitation method

development and validation

Highly self-motivated, goal orientated, good interpersonal skills

and excellent oral and written communication

Page 11: Founded in August 2009, in Nanjing, China  SFDA GLP and AAALAC certified DMPK CRO company  GLP bioanalytical support for small and macro molecule,

Address: 9 Xinglong Road,

Pukou Economic Development Zone, Nanjing,

China

Email: [email protected]

Website: www.concordpharmatech.com

Tel: 011-86 25-58196598

VOIP: 1 908 691-4648