Easter Seals Jobs

Basic Purpose of the job

This position is responsible for technical and managerial leadership in developing state of the art solid oral formulations and robust manufacturing processes for mutiple complex projects in collaboration and coordination with internal and external partners.

Accountabilities

Develop solid oral formulations and manufacturing process for multiple complex NCE projects

Related Performance Indicators

'-Lead development of new formulations and robust manufacturing process for NCE projects

-Closely cooperate with Analytical Sciences to ensure quality of drug products developed

Author key documents of quality sections for global submissions

Related Performance Indicators

'-Prepare submission documents for NDA and CTA

-Interact with Regulatory Affairs and CMC Experts internally as well as regulatory authorities externally to obtain approvals on MAA and CTA

Manufacture clinical supply bulk for clinical trials by transfer of know-how

Related Performance Indicators

'-Develop manufacturing specifications for clinical supplies

-Transfer clinical bulk manufacturing to internal and external partners

Represent the discipline as Team Member of Pharmaceutics on international R&D Teams

Related Performance Indicators

'-Summarize all results, present all relevant data to the international R&D Team and prepares decisions

-Communicate and implement all team decisions within the department (matrix management function)

-Communicate and resolve conflict

-Leading the Formulation Subteam in Drug&Device Deliverable Team

Organize and supervise the technology transfer to receiving sites

Related Performance Indicators

'-Plan, prepare and conduct technology transfers meeting requirements

• Prepare documentations required for the transfer

Maximize the efficiency and motivation of the formulation subteam

Related Performance Indicators

'-Allocate tasks to team members properly

-Lead the formulation subteam globally and locally to maximize speed of formuation development with optimal laboratory resources

Promote internal and external innovations

Related Performance Indicators

'-Scout external new technologies/ideas to provide values to pipeline projects

-Encourage and promote internal innovations

Requirements:

-Extensive knowledge of formulation and manufacturing process development for solid oral dosage forms

• More than 7 years of experience in an international pharmaceutical R&D organization

-Sufficient CMC background with proven performance record (not less than 3 cross-functional projects)

-Undestanding of relevant global regulatory guidelines and submission/approval requirements (in particular FDA, EMEA, PMDA)

• PhD in science

-Excellent oral and written presentation skills in English

-International work experience (cross-cultural competence)

Recruiter : Suzuki

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.