Manager, New Plasma Product Development

CSL   •  

Kankakee, IL

Industry: Medical Devices & Diagnostics

  •  

8 - 10 years

Posted 394 days ago

Designs and implements business processes to enable product research and development portfolio prioritization, resource allocation, and risk management. Designs related integrated process and product team activities and directs technical and operational activities to ensure vertical and horizontal integration. Provides product portfolio analyses and reports to management committees for support of decision-making. Leads teams in strategy efforts, lifecycle management planning, and assessments of probability-of-success. Develops systems to support dynamic portfolio management. Serves a key role in portfolio evaluation process. Drives initiatives across functions, research and development units to create fully integrated strategies. Monitors and reports on portfolio status and proactively addresses andresolves issues.

Position Purpose

Actively seek new opportunities for therapeutic areas for plasma proteins.  Coordinate the purification development and manufacture of research grade material in support of internal and external pre-clinical research studies.  Coordinate scientific and investigative studies internally or through collaboration with internal customers, academic research organizations and other global CSL R&D sites.  Be the technical expert in developing purification processes, developing stabile formulations for the newly purified plasma proteins, implementing novel virus reduction technologies, or technical information as necessary to develop new plasma products

Main Responsibilities and Accountabilities

1. Responsible for managing the day to day laboratory operations required for development of purification processes and analytical techniques used to purify and quantify unused plasma proteins.

2. Responsible for coordinating scientific and investigative studies through collaboration with internal customers, global R and D sites, academic research organizations, contract laboratories, etc., and think creatively and provide technical justification for novel concepts and approaches.

3. Responsible for establishing legal agreements (MTA’s, Research Agreements/Collaborations) with external research collaborators in collaboration with CSL Legal and Patents and Licenses Department.

4. Actively seek new opportunities for therapeutic areas for plasma proteins, contribute key ideas to projects, and promote area of expertise to achieve results through participating in national and international organizations.

5. Actively participate in global R and D meetings, provide project updates to the committee, and present new project opportunities. 

6. Serve as PSC (project scientific coordinator) for all early research projects actively being developed in Kankakee under the authority of the RPMC.  Report monthly projects progress and provide project specific presentations to the RPMC, as required.

7. Responsible for establishing appropriate personnel development plans that encompass needs of the group and larger department.  Execute performance evaluations of direct reports and maintain professional performance documentation during the year.

8. Perform budget planning for assigned R and D projects.  Analyze resource needs, interview, hire, train, develop and oversee/supervise staff. 

9. Responsible for planning and participating in experiments for the development and/or optimization of new purification processes and/or analytical methods.  Including the establishment of virus reduction steps and final formulation screening experiments

10. Maintain an advanced level of documentation and communication through timely and thorough drafting and execution of protocols and reports in support of new processes.  Report results in a timely manner to site/global management as well as external collaborators.

11. Responsible for performing fundamental literature and patent searches related to activities and develop alternative strategies. Collaborate with Patents and Licenses Department to determine freedom to operate capabilities and novelty of discoveries.

12. Maintain an advanced level of scientific excellence and collaborator contact by regularly attending regional and national technical meetings, whenever possible.

13. Responsible for providing the necessary information for the establishment of costs and standards.  Financial responsibility includes annual budget and fiscal year forecast updates.

Reporting Relationship

Reports To: Sr. Manager /Assoc. Dir / Director NPPD and Operations Support

Qualification Requirements

Education: Combination of Education and appropriate experience, such as BS/BA 8 - 12 years, MS/MA +3-5 years, or Ph.D. + 2 years needed to establish a strong background and knowledge base.

Experience: Knowledge of and competency in a wide variety of protein purification methods, familiarity with protein formulation and analytical techniques.  Experience in selection of potential candidates to fill vacant technical positions.  Experience in collaborations with groups within and outside of the company.  Must have experience in leading  and directing other employees.

Competencies

Proven organizational and interpersonal skills. Cross-Cultural-Sensitivity, efficient use of networking. Customer focused. Effective written and oral communication skills.   Possess strong leadership skills; Managerial Courage; effective hiring and staffing; and coaching/mentoring skills to facilitate knowledge sharing.  Problem solving abilities, creativity, efficient time management. Analytical and conceptual thinking. Decisiveness and Action Oriented.

Working Conditions

May be required or lift up to 30 pounds and sit for long periods.

Travel Requirements

Up to 10% domestic or international travel.

R-047326