Johnson & Johnson companies are equal opportunity employers.
PRINCIPAL SCIENTIST-6756131213
Description
Mentor Worldwide L.L.C., a Johnson and Johnson Company is recruiting a Principal Scientist, located in Madison, Wisconsin.
Mentor Worldwide L.L.C. is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
As a team of Technical Service, the Principal Scientist will lead and participate in C. Botulium Neurotoxin; manufacturing process improvement, optimization, validation, transfer, manufacturing process investigation, and trouble-shooting activities. Will take responsibility for C. Botulium Neurotoxin A process improvement, including yield increase, process consistency improvement, process cycle reduction, formulation optimization, etc. Will develop process improvement plans and business justifications. Write and/or review process optimization, process validation, transfer, comparability protocols and reports. Lead or participate manufacturing process event investigation, root cause analysis, and trouble-shooting. Write event deviation and investigation updates and reports. Modify and/or review master batch records. Oversee ongoing projects and acts as a main contact for stakeholders in discussions. Participate in BLA and post BLA regulatory writing. Resolve comprehensive technical problems and ensures that remedial actions are taken whenever systems fail to meet acceptable performance specifications. Study work processes, measurements and performance metrics to identify improvement areas. Interface with contract manufacturing organization, suppliers, customers, and peers to define and improve project performance and expectations. Evaluate new equipment and write and revise standard test/operational procedures. Evaluate data on internal and external complaints to establish focused plans for correcting repetitive problems.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Qualifications
A Master’s degree in Chemical Engineering, Biochemistry, Bioengineering, Protein Chemistry, Chemistry, or other relevant scientific discipline with at least 8 years of experience in the field of biotechnology, microbial fermentation development or protein purification development, and/or biotechnology product manufacturing is required OR a PhD in Chemical Engineering, Biochemistry, Bioengineering, Protein Chemistry, Chemistry, or other relevant scientific discipline with at least 5 years of experience in the field of biotechnology, microbial fermentation development or protein purification development, and/or biotechnology product manufacturing is preferred.
Extensive experience and knowledge in protein product process development & optimization, especially protein purification, is required.
Experience with bacterial fermentation is preferred.
Extensive experience in cGMP manufacturing event investigations and root cause analysis is required.
Experience and/or certification in Process Excellence (for example Lean, Six Sigma, etc) is preferred.
Experience with pharmaceutical regulatory and ICH guidelines, especially those relevant to GMP manufacturing ,validation, and quality risk management is preferred.
Strong oral and written communication skills, project management experience, and strong computer skills are required.
Strong process data analysis skills supported by familiarity with analytical methods for protein characterization and quantization is required.
This role requires the qualified individual to be willing and able to work in an environment where bacterial toxins are manufactured under good biological safety controls.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Wisconsin-Madison
Organization: Mentor Worldwide LLC (6177)
Job: R&D
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
PRINCIPAL SCIENTIST-6756131213
Description
Mentor Worldwide L.L.C., a Johnson and Johnson Company is recruiting a Principal Scientist, located in Madison, Wisconsin.
Mentor Worldwide L.L.C. is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
As a team of Technical Service, the Principal Scientist will lead and participate in C. Botulium Neurotoxin; manufacturing process improvement, optimization, validation, transfer, manufacturing process investigation, and trouble-shooting activities. Will take responsibility for C. Botulium Neurotoxin A process improvement, including yield increase, process consistency improvement, process cycle reduction, formulation optimization, etc. Will develop process improvement plans and business justifications. Write and/or review process optimization, process validation, transfer, comparability protocols and reports. Lead or participate manufacturing process event investigation, root cause analysis, and trouble-shooting. Write event deviation and investigation updates and reports. Modify and/or review master batch records. Oversee ongoing projects and acts as a main contact for stakeholders in discussions. Participate in BLA and post BLA regulatory writing. Resolve comprehensive technical problems and ensures that remedial actions are taken whenever systems fail to meet acceptable performance specifications. Study work processes, measurements and performance metrics to identify improvement areas. Interface with contract manufacturing organization, suppliers, customers, and peers to define and improve project performance and expectations. Evaluate new equipment and write and revise standard test/operational procedures. Evaluate data on internal and external complaints to establish focused plans for correcting repetitive problems.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Qualifications
A Master’s degree in Chemical Engineering, Biochemistry, Bioengineering, Protein Chemistry, Chemistry, or other relevant scientific discipline with at least 8 years of experience in the field of biotechnology, microbial fermentation development or protein purification development, and/or biotechnology product manufacturing is required OR a PhD in Chemical Engineering, Biochemistry, Bioengineering, Protein Chemistry, Chemistry, or other relevant scientific discipline with at least 5 years of experience in the field of biotechnology, microbial fermentation development or protein purification development, and/or biotechnology product manufacturing is preferred.
Extensive experience and knowledge in protein product process development & optimization, especially protein purification, is required.
Experience with bacterial fermentation is preferred.
Extensive experience in cGMP manufacturing event investigations and root cause analysis is required.
Experience and/or certification in Process Excellence (for example Lean, Six Sigma, etc) is preferred.
Experience with pharmaceutical regulatory and ICH guidelines, especially those relevant to GMP manufacturing ,validation, and quality risk management is preferred.
Strong oral and written communication skills, project management experience, and strong computer skills are required.
Strong process data analysis skills supported by familiarity with analytical methods for protein characterization and quantization is required.
This role requires the qualified individual to be willing and able to work in an environment where bacterial toxins are manufactured under good biological safety controls.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Wisconsin-Madison
Organization: Mentor Worldwide LLC (6177)
Job: R&D
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.