Project Leader Clinical and Scientific Affairs Cellular Therapies
Deerfield, IL
Req ID 50910BR
Business Title
Project Leader, Clinical and Scientific Affairs, Cellular Therapies
Business
Corp Innovation and Development
Sub-Business
Cellular Therapies
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
Key Summary (Detailed Description Below)::
This position is with the Cellular Therapies group which supports clinical trials utilizing stem cells in therapeutic areas of regenerative medicine . Specifically, the individual will support the manufacture of the biological components of the Isolex system used for the selection of CD34+ stem cells from mobilized apheresis products.
The individual in this role will be responsible for:
• Working with internal and external manufacturing plants responsible for the manufacture and release of key components of the Isolex reagent kit. Ensure that the reagents are available and suitable for use in different geographies.
• Providing input for system improvements to the biological component of the Isolex Stem Cell Selection System.
• Writing, updating or reviewing, in a timely fashion, documents needed to support the manufacture of the reagents used as part of the Isolex cell selection system.
• Assisting in introducing changes into the current manufacturing processes to meet the projected future demands of the business.
• Working with other team members to prepare documents for regulatory submissions in different geographies.
• Maintaining familiarity with Baxter design process for medical devices and pharmaceuticals. Maintain familiarity with regulatory guidance documents related to the manufacture of biologics for clinical use.
The ideal candidate for this position will have as a minimum a master's degree in hematology, immunology, biochemistry or molecular biology with at least five years experience in working in a corporate environment. Alternatively, candidates with a PhD in one of the above disciplines should have either a minimum of three years of industrial experience or have completed one Post Doctoral Research position.
Knowledge of biotechnology manufacturing methods and techniques including monoclonal antibody production, fermentation and testing is an advantage. Candidates are expected to be highly computer literate with experience in Microsoft Office as a minimum. Candidates will be expected to demonstrate their writing skills, through submission of materials they have independently prepared.
Please review and apply at company website , position # 50910BR.
Detailed Description:
Technical project leader supporting clinical trials utilizing stem cells in therapeutic areas of regenerative medicine. Specifically, support the manufacture of the biological components of the Isolex system used for the selection of CD34+ stem cells from mobilized apheresis products.
You'll be expected to oversee the manufacture of elements of the Isolex reagent kit that takes place in a variety of manufacturing facilities both within and outside of Baxter. You will also be responsible for assisting in introducing changes into the current manufacturing processes to meet the projected future demands of the business.
Required: background in immunology, hematology or biochemistry; experience in manufacturing desirable. Requires that you become familiar with Baxter's Design Control Processes for both biopharmaceuticals and medical devices.
Excellent writing and communication skills are required, as is the ability to work in a highly matrixed team environment.
• Be prepared to work with internal and external manufacturing plants responsible for the manufacture and release of key components of the Isolex reagent kit. Ensure that the reagents are available and suitable for use in different geographies.
• Provide input for system improvements to the biological component of the Isolex Stem Cell Selection System.
• Write, update or review, in a timely fashion, documents needed to support the manufacture of the reagents used as part of the Isolex cell selection system.
• Work with other team members to prepare documents for regulatory submissions in different geographies.
• Maintain familiarity with Baxter design process for medical devices and pharmaceuticals. Maintain familiarity with regulatory guidance documents related to the manufacture of biologics for clinical use.
• Responsibility for coordinating the completion of documentation related to the Biologics program.
Job Requirements
• Knowledge of biotechnology manufacturing methods and techniques including monoclonal antibody production, fermentation and testing.
• Background in hematology, immunology, biochemistry or molecular biology
• Broad knowledge of design control for medical devices and pharmaceuticals
• Must be able to work within a team comprising of members with a variety of different skills and drive projects to completion in a timely manner.
• Ability to convey complex ideas through verbal, and written skills. Must be highly detailed orientated and show interpersonal skills and the ability to solve problems.
• At a minimum, masters degree in hematology, immunology, biochemistry or molecular biology with at least five experience in working in a corporate environment. Alternatively, candidates with a PhD in one of the above disciplines should have either a minimum of three years of industrial experience or have completed one Post Doctoral Research position. Knowledge of biotechnology manufacturing methods and techniques including monoclonal antibody production, fermentation and testing is an advantage.
• Candidates are expected to be highly computer literate with experience in Microsoft Office as a minimum.
• Candidates will be expected to demonstrate their writing skills, through submission of materials they have independently prepared.
The position will be based in Baxter's offices in Deerfield, IL , (Chicago) with the possibility of having to travel to Baxter's manufacturing facilities on an occasional basis.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
