Summary
The successful candidate for Drug Product Development & Delivery (DPD&D)- Biologics, Asia-pacific, will work closely with global Therapeutics Development and Supply (TDS) and external partners on biologics drug product development in Asia Pacific region. Responsibilities include but are not limited to:
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Shanghai, ChinaJob Description:
- Lead formulation/process development study to support Biologics DP development activities at external sites;
- Write and/or review technical documents including study reports, batch records, memos;
- Interface with different functional groups and communicate effectively with internal and external partners;
- Act as subject matter expert on formulation/process development, excipients and container closure;
- Comply with company policy during daily operation, ensure data integrity to support authoring regulatory documents;
- Draft regulatory filing documents and perform technical review;
- Partners with cross functional groups to ensure processes are consistent with J&J platforms and are in compliance with the submitted CMC dossiers and general cGMP regulations.
· PhD or other advanced degree in Pharmaceutical Sciences, Chemical Engineering or a related field with at least 3 years of experience. Candidates with MS degree in a related field and at least 6 years of working experience will also be considered;
· Solid knowledge in biologics drug product development is a must;
· Antibody drug conjugate (ADC) development and manufacturing experience are highly preferred;
· Previous experience in a GMP working environment is highly preferred;
· Good communication skills in both writing and speaking in English is highly preferred;
· Experience with multi-national pharmaceutical companies is preferred;
· Experience of the biologics drug dosing design and administration in various clinical development stages is a plus;
· Proven track record of creativity and problem solving and ability to collaborate with cross functional teams.
· Up to 30% domestic and international travel
· PhD or other advanced degree in Pharmaceutical Sciences, Chemical Engineering or a related field with at least 3 years of experience. Candidates with MS degree in a related field and at least 6 years of working experience will also be considered;
· Solid knowledge in biologics drug product development is a must;
· Antibody drug conjugate (ADC) development and manufacturing experience are highly preferred;
· Previous experience in a GMP working environment is highly preferred;
· Good communication skills in both writing and speaking in English is highly preferred;
· Experience with multi-national pharmaceutical companies is preferred;
· Experience of the biologics drug dosing design and administration in various clinical development stages is a plus;
· Proven track record of creativity and problem solving and ability to collaborate with cross functional teams.
· Up to 30% domestic and international travel