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师妹盈盈

应助: (幼儿园)
在线:
虫号: 432890

Leader

Job Title:
Dir, Research

Function:
Research

Supervisor's Title:
VP Manufacturing

Summary:
Under general management direction, achieve goals and objectives designed in coordination with other senior management in the division. Guide doctorate and/or high professional level professionals/researchers/scientists in their assigned project activities. Establish business/technical objectives of research project groups and advise on problem solving efforts in own area and others'. Duties are guided by broad policies and specific objectives. Assume significant responsibility for the size, importance, cost and timelines of a critical project. Responsible for meeting major objectives for the company, which is shared with other senior management in the division.

Essential Duties and Responsibilities:
. Create and communicate a global vision of the organization's contribution to the business goals, insuring industry leadership. Inspire team to action consistent with vision. Establish high standards and stretch goals for organization. Remove barriers to outstanding performance. Hold team accountable for successful completion of projects/tasks.

· Establish long-range business plans which anticipate global trends, technical, economic and socio-political conditions and provide support for project/business strategy.

· Select, develop and retain team that includes more senior level technical contributors. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Successfully coach, mentor and motivate others for outstanding performance, including areas such as innovation, trade secrets, patents, and publications.

· Ensure development of state-of-the-art expertise in pharmaceutical product development including liquid formulation sciences, analytical method development/validation, and pharmaceutical process development.  Working knowledge of Good Documentation Practices and GMP manufacturing.  Understand pharmaceutical regulatory environment (agency and ICH guidance, compendial requirements) and apply principles to product development and support.

· Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.

· Define and communicate strategic imperatives to project success (i.e.: timing of market entry, innovative technology and costs). Develop strategic plans that incorporate regional and global business practices and customer needs.

· Develop effective program milestones, schedules and budgets, including capital. Employ state-of-the-art project management tools to manage to those project schedules and budgets against milestones; review and apply best-demonstrated practices, team processes, and improve operational efficiency. Identify and resolve issues that may jeopardize project schedules or improve project time.

· Develop budgets for each cost center within scope of responsibility which ensure the best utilization financial resources.

· Proactively prioritize and balance utilization of resources allocated to project; identify opportunities to cross-train, back-fill. Develop recommendations for outside resources as required for the team/project; present internal vs. external analysis.

· Understand and effectively communicate to team members about the market niche, competitive forces influencing the project, and how the project fits into the function's strategic focus/plan. Ensure that team objectives align with key Corporate strategic programs. Accountable for successfully meeting agreed upon milestones for key Corporate projects.

· Generate innovative solutions to complex problems through the use of multiple disciplines and technical principles. Create innovative products/processes/methods through novel combinations of expertise within the organization.  Have a strong science based knowledge of physical organic chemistry and analytical chemistry and the experience to apply these disciplines to product development. Understanding of pharmaceutical sciences to understand important factors that influence utility of products including solution properties (osmolality, pH, isotonicity), excipients, impurities, stability studies and product expiry.

· Build a professional network both internally within the business unit, across units and outside of ***.  Maintain professional contacts and participate in industry associations create awareness of pharmaceutical product state-of-the-art concepts.

· Direct team members to effectively transfer technology from design development to implementation.

· Maintain current knowledge of relevant Quality System Regulations and *** corporate requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.

Qualifications:
Must possess strong knowledge of scientific disciplines and solid knowledge of related disciplines relating to pharmaceutical, physical chemistry, and analytical chemistry. Knowledge of quality and general business systems. Must possess strong ability to negotiate for resources and influence others internally and externally. Must be able to set strategic direction for the organization and broadly communicate the vision.

Education and/or Experience:
BS in related scientific discipline, with 16+ years, MS with 13+ years, or PhD with 10+ years relevant experience. Minimum 5 years technical management experience including cross-functional teams, resource and budget management and strategic development experience

Job Title:
Mgr II, Research

Function:
Research

Supervisor’s Title:
Director or VP Research

Summary:
Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget.
Based on significant technical expertise, reviews and approves complex design concepts and provides general direction to technical staff.
Understands pharmaceutical product development including formulation, analytical method, GDP, and GMP.  Applies these principles in management of R&D group and business.
Acknowledged outside of business unit or division for input on programs of some magnitude. Exhibits creativity and innovation in completing magnitude.
Exhibits creativity and innovation in completing divisional and cross-functional/business unit responsibilities.

Essential Duties and Responsibilities:
Select, develop and retain team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Successfully coach, mentor and motivate others for outstanding performance, including areas such as product development, innovation, trade secrets, patents, and publications.
Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
Define and communicate strategic imperatives to project success (i.e.: timing of market entry, innovative technology and costs). Develop strategic plans that incorporate regional and global business practices and customer needs.
Develop effective project milestones, schedules and manage budgets, including capital. Employ state-of-the-art project management tools to manage to those project schedules and budgets against milestones; review and apply best-demonstrated practices, team processes, and improve operational efficiency. Identify and resolve issues that may jeopardize project schedules or improve project time. Seek regular input and feedback from customers and take appropriate action.
Proactively prioritize and balance utilization of resources allocated to project; identify opportunities to cross-train, back-fill. Develop recommendations for outside resources as required for the team/project; present internal vs. external analysis.
Understand and effectively communicate to team members about the market niche, competitive forces influencing the project, and how the project fits into the function's strategic focus/plan. Ensure that team objectives align with key Corporate strategic programs. Accountable for successfully meeting agreed upon milestones for key Corporate projects.
Generate innovative solutions to complex problems through the use of multiple disciplines and technical principles. Create innovative products/processes/methods through novel combinations of expertise within the organization.
Build a professional network both internally within the business unit, across units and outside of ***.
Direct team members to effectively transfer technology from design development to implementation.
Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.

Qualifications:
Must be well versed in scientific disciplines.
Must possess knowledge of related disciplines in pharmaceutical and chemical sciences.  These include formulation chemistry, analytical chemistry, chromatographic methods, sterility assurance, pharmaceutical science.
Must have knowledge of such principles as GMPs, Regulatory Agency guidelines, ICH guidelines, compendial pharmacopeia, and *** business practices.
Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
Ability to manage multiple cross-functional teams simultaneously.
Ability to design and implement projects/studies outside area of expertise.
Must demonstrate strategic leadership and proficient supervisory skills.
Display ability to communicate effectively using a wide variety of skills and vehicles.

Education and/or Experience:
BS in related scientific discipline 13+ years, MS with 10+ years , or Ph.D. 6+ years of product development or related experience.
Several years technical management experience, resource and budget management.

Job title: Development Research Scientist For Analytical

Roles:

***  development research scientist shall act as technical expertise for pharmaceutical chemistry analysis in the  ***  development program.



Main Job responsibilities:

1. Conducts research or designs strategies to achieve the technical vision for a new or improved product/process/method or to prove a new theory;

2. Applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise;

3. Provides assistance and interpretation of project results to team members and other business unit personnel;

4. Work on the bench (e.g. develop analytical methods, adapt new technologies) with a focus on chromatography (HPLC, GC), titration and various spectroscopic methodologies (e.g. IR ).

5. Develop and validate analytical methods, create all necessary data for Asia Pacific product registration and method transfer to production units.

6. Create and execute complex design and technical tasks, integrating information from a variety of disciplines;

7. Recognized for technical expertise within area of technical specialty;

         Qualification and requirements:

1. Sound knowledge in R&D process/system;

2. Good understanding of GLP and GDP practice as well as ICH requirements;

3. Good English communication skills;

4. Relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills;

Education and experience:

1. Bachelor's degree in a scientific discipline with at least 15 years of relevant experience, MS with at least 10 years, or PhD with at least 3-4 years of relevant experience. Preferably majored in analytical chemistry, or pharmaceutical sciences;

2. Experience in developing final sterilized, liquid formulated products is a big plus;

3. QSR research experience is essential and GMP experience useful. Lab experience includes research in GMP/GLP/QSR environment; leadership of technical teams, and project management experience is desirable.

[ Last edited by 师妹盈盈 on 2009-1-6 at 18:06 ]

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