东莞市智翔工艺品有限公司

智翔工艺品公司名称

智字的取名意思：指智慧、见识、聪明，如足智多谋。

翔字的取名意思：指吉利、详尽、上涨、悠闲自在地行走。

智翔工艺品公司岗位职责

抗体工艺开发项目经理 senior manager/associate director/director, cmc project lead

job description

position summary

this is an exciting opportunity for motivated individual to enrich and broaden his/her biopharmaceutical development experience for both career advancement, and at the same time, making meaningful impact to patient lives in one of the highly regarded and fast growing biotech companies in china.

this cmc project lead and manager, working with the cmc team members, is responsible for product cmc strategy, planning and execution by leading and managing a cmc team consisting of technical representatives. he/she will support two or more biologics projects in all cmc aspects of product development from clinical phase i to commercialization. the cmc project lead will focus on the cmc strategic and operational aspects of the program while also supporting the team in making complex cross-functional decisions (e.g., scenario planning, risk assessment, setting strategic priorities). this role will report to the vp, cmc operations.

responsibilities

the primary responsibility will be leading and managing project cmc team, ensuring that project priorities and plans are developed and executed in accordance with corporate goals.

• identification, planning, and execution of key program cmc initiatives and milestones to support corporate goals.

• lead the project cmc team in making complex cross-functional recommendations / decisions

• lead and manage team meetings and agenda topics, facilitate discussions, propose/recommend key decisions, and follow up with action items.

• ensure alignment of objectives, plans, and activities across various cmc functions (e.g., r&d, process development, analytical chemistry, qc, qa, manufacturing, regulatory affairs, supply chain, etc.).

• familiar with operational aspects of the program and produce documents and visual tools to facilitate project tracking and progress (e.g., decision and action logs, planning trackers, timelines, etc.).

• develop and maintain strong, collaborative relationships with key stakeholders

• ensure that timely and consistent communications regarding program strategy, status and decisions are made within the team and to other stakeholders, including senior management.

qualifications

• education: a bachelor of science in scientific fields (e.g. biology, chemistry, engineering, or pharmacy) required. advanced degree (masters or phd in a scientific discipline) is preferred but not required. professional training/experience in project management is a plus.

• 8+ years’ experience in a biotech or pharmaceutical organization in drug development with expertise/knowledge in such functions as process development, manufacturing and engineering, quality, analytical chemistry, formulation, supply chain, regulatory affairs

self-motivated, and eager to learn; strong ownership, and ability to follow through with direction/tasks; proactive and positive when facing challenges

• comfortable working in a team environment, and can motivate and help others to achieve cmc goals with team efforts

• high degree of professionalism, respectful to others and ability to work in fast-paced and dynamic environment

• working knowledge of overall drug/biologics development process and familiar with various functional areas and their roles within a biotech / pharmaceutical company.

• prior experience in supporting pre-clinical and/or clinical-stage drug development programs, preferably across different phases (e.g. phases i–iii).

• some knowledge of cgmp is desirable

•excellent collaboration, oral and written communications, influence skills and sound judgment

• ability to communicate to both broader organization and the senior management

• ability to multi-task and shift priorities quickly while working under tight deadlines; ability to work under uncertainty

• attention to detail, highly organizational, and willingness to learn quickly

• good skills in common word processing tools (such as words, powerpoint, excel, and ms project)

• title will commensurate with individual’s experience and qualifications

senior manager/associate director/director, cmc project lead

job description

position summary

this is an exciting opportunity for motivated individual to enrich and broaden his/her biopharmaceutical development experience for both career advancement, and at the same time, making meaningful impact to patient lives in one of the highly regarded and fast growing biotech companies in china.

this cmc project lead and manager, working with the cmc team members, is responsible for product cmc strategy, planning and execution by leading and managing a cmc team consisting of technical representatives. he/she will support two or more biologics projects in all cmc aspects of product development from clinical phase i to commercialization. the cmc project lead will focus on the cmc strategic and operational aspects of the program while also supporting the team in making complex cross-functional decisions (e.g., scenario planning, risk assessment, setting strategic priorities). this role will report to the vp, cmc operations.

responsibilities

the primary responsibility will be leading and managing project cmc team, ensuring that project priorities and plans are developed and executed in accordance with corporate goals.

• identification, planning, and execution of key program cmc initiatives and milestones to support corporate goals.

• lead the project cmc team in making complex cross-functional recommendations / decisions

• lead and manage team meetings and agenda topics, facilitate discussions, propose/recommend key decisions, and follow up with action items.

• ensure alignment of objectives, plans, and activities across various cmc functions (e.g., r&d, process development, analytical chemistry, qc, qa, manufacturing, regulatory affairs, supply chain, etc.).

• familiar with operational aspects of the program and produce documents and visual tools to facilitate project tracking and progress (e.g., decision and action logs, planning trackers, timelines, etc.).

• develop and maintain strong, collaborative relationships with key stakeholders

• ensure that timely and consistent communications regarding program strategy, status and decisions are made within the team and to other stakeholders, including senior management.

qualifications

• education: a bachelor of science in scientific fields (e.g. biology, chemistry, engineering, or pharmacy) required. advanced degree (masters or phd in a scientific discipline) is preferred but not required. professional training/experience in project management is a plus.

• 8+ years’ experience in a biotech or pharmaceutical organization in drug development with expertise/knowledge in such functions as process development, manufacturing and engineering, quality, analytical chemistry, formulation, supply chain, regulatory affairs

self-motivated, and eager to learn; strong ownership, and ability to follow through with direction/tasks; proactive and positive when facing challenges

• comfortable working in a team environment, and can motivate and help others to achieve cmc goals with team efforts

• high degree of professionalism, respectful to others and ability to work in fast-paced and dynamic environment

• working knowledge of overall drug/biologics development process and familiar with various functional areas and their roles within a biotech / pharmaceutical company.

• prior experience in supporting pre-clinical and/or clinical-stage drug development programs, preferably across different phases (e.g. phases i–iii).

• some knowledge of cgmp is desirable

•excellent collaboration, oral and written communications, influence skills and sound judgment

• ability to communicate to both broader organization and the senior management

• ability to multi-task and shift priorities quickly while working under tight deadlines; ability to work under uncertainty

• attention to detail, highly organizational, and willingness to learn quickly

• good skills in common word processing tools (such as words, powerpoint, excel, and ms project)

• title will commensurate with individual’s experience and qualifications