Position Overview
Finish late-stage PC relevant work and early-stage development of antibody program with limited instructions, as intermediate individual contributor, finish most common DP development work, contribute to the DP platform of the company and DP program development.
Job responsibilities:
1.Late-stage PC relevant work
Responsible for pre-PC risk assessment, experiment design, experiment execution, data analysis, report draft, post-PC risk assessment, etc.
Participate in deviation and change control from MFG/QC.
Communicate with TD, MF, QA, QC, RA and outsourced partners to finish the relevant DP work.
2.Early-stage DP relevant work
Responsible for formulation development, DP process development, CCS choosing, tech transfer for early-stage IND programs, including liquid DP and lyo DP.
Independently perform DP development work with limited instructions.
3.Others
Instruct and review lower-level colleagues in DP development work if needed.
Help coordinate projects and review the work result of others within work area.
Finish other work assigned by mangers.
Job requirement:
1.Professional Knowledge
Have most tech skills of DP development (including formulation, PPM, DP process), as intermediate individual contributor, design experimental protocol and finish routine DP development work independently, including liquid DP and lyo DP.
Proficient in late-stage process characterization study, DoE software (JMP, minitab, etc.) and data analysis, etc.
Proficient in most quality analytical methods and equipments in DP development, such as MFI, DLS, visual inspection, viscosity, lyophilizer, etc.
2.Strong ability of trouble shooting in most of common DP problems with limited instructions.
3.Familiar with DP parts in regulations, USP/EP/CP, ICH guidelines, especially late-stage PC relevant regulations.
4.Good project management capability, can coordinate resources within and outside FDPD department to participate in small and medium-size projects.
5.Strong willingness to work closely with peers within and outside the team toward a common goal.
6.Basic reading and writing English skills.
7.Basic IT skills (Windows, Office, etc.)
Education background:
College or above degree in Biochemistry, Analytical chemistry, Bioengineering, Pharmacy, etc.
For MS, at least 4-year DP experience in biopharmaceutical, at least 1 protein program late-stage PC experience.
For BS, at least 6-year DP experience in biopharmaceutical, at least 1 protein program late-stage PC experience.