Sr. Principal Scientist

Shanghai - China

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmaceutical Product R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Shanghai China

Job Description:

Oversee analytical activities for the R&D and commercial portfolio at CROs located in China.
Provide analytical technical guidance and trouble-shooting support to analytical teams in CRO and other external partners. Review technical documents (protocols/reports) from CRO to ensure GMP compliance.
Ensure cGMP compliance in all aspects of activities performed at CROs where relevant.
Track performance and provide reports on metrics to Management.
Seek creative approaches to improve the accuracy reliability flexibility and productivity of the analytical development activities in China.
Enhance engagement with Health Authorities to help influencing regulatory landscape in China.
Closely collaborate in a global environment together with multidisciplinary teams in China India US and Europe.
Qualifications
You hold a masters degree in Chemistry Pharmacy or equivalent with excellent knowledge of analytics stability and specs. PhD in same fields preferred.
You have at least 5-8 years of senior level industry experience in global medium-size pharmaceutical development or research entities or CRO.
Broad and strong scientific analytical chemistry knowledge in the CMC field which includes but not limited to analytical method development and validation GMP release testing stability study for both API and Drug Product.
Strong expertise in CMC small molecules early development with focus on moving compounds from discovery to NME and FIH. Experience with Analytical Development supporting both API and DP is preferred. Experience of working in a matrix environment together with other functions (API DP RA QA ) to deliver on CMC goals.
Strong interpersonal skills to effectively communicate with external sites and various internal and external functional areas.
Good understanding of global Regulatory requirements and ability to respond as to authority questions.
Ability to prioritize and balance compliance with business needs.
Experience of microbial testing is a plus.
Manager experience is a plus.
Competencies
Strong leadership skills are required.
You can work independently though you are also an excellent team player.
Efficient flexible and dynamic.
Demonstrate capabilities in strategic thinking
Sense of Urgency
Excellent communication skills.
You have a good knowledge of English both spoken and written.
Good English scientific writing skills.
Chinese language is required for working with local CROs.

Required Skills:

Preferred Skills:

Budget Management Chemistry Manufacturing and Control (CMC) Clinical Trial Protocols Drug Discovery Development Industry Analysis Interdisciplinary Work Market Research Pharmacokinetic Modeling Process Improvements Product Development Product Licensing Product Strategies Risk Management Scientific Research Standard Operating Procedure (SOP) Tactical Planning Technical Credibility

Required Experience:

Staff IC

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmaceutical Product R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Shanghai China

Job Description:

Oversee analytical activities for the R&D and commercial portfolio at CROs located in China.
Provide analytical technical guidance and trouble-shooting support to analytical teams in CRO and other external partners. Review technical documents (protocols/reports) from CRO to ensure GMP compliance.
Ensure cGMP compliance in all aspects of activities performed at CROs where relevant.
Track performance and provide reports on metrics to Management.
Seek creative approaches to improve the accuracy reliability flexibility and productivity of the analytical development activities in China.
Enhance engagement with Health Authorities to help influencing regulatory landscape in China.
Closely collaborate in a global environment together with multidisciplinary teams in China India US and Europe.
Qualifications
You hold a masters degree in Chemistry Pharmacy or equivalent with excellent knowledge of analytics stability and specs. PhD in same fields preferred.
You have at least 5-8 years of senior level industry experience in global medium-size pharmaceutical development or research entities or CRO.
Broad and strong scientific analytical chemistry knowledge in the CMC field which includes but not limited to analytical method development and validation GMP release testing stability study for both API and Drug Product.
Strong expertise in CMC small molecules early development with focus on moving compounds from discovery to NME and FIH. Experience with Analytical Development supporting both API and DP is preferred. Experience of working in a matrix environment together with other functions (API DP RA QA ) to deliver on CMC goals.
Strong interpersonal skills to effectively communicate with external sites and various internal and external functional areas.
Good understanding of global Regulatory requirements and ability to respond as to authority questions.
Ability to prioritize and balance compliance with business needs.
Experience of microbial testing is a plus.
Manager experience is a plus.
Competencies
Strong leadership skills are required.
You can work independently though you are also an excellent team player.
Efficient flexible and dynamic.
Demonstrate capabilities in strategic thinking
Sense of Urgency
Excellent communication skills.
You have a good knowledge of English both spoken and written.
Good English scientific writing skills.
Chinese language is required for working with local CROs.

Required Skills:

Preferred Skills:

Required Experience:

Staff IC

Key Skills

Machine Learning
Python
Data Science
AI
R
Research Experience
Sensors
Drug Discovery
Research & Development
Natural Language Processing
Data Analysis Skills
Toxicology Experience

Apply Now

About Company

Johnson & Johnson

About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

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