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Senior Galenic Development Researcher - Established Pharmaceuticals Division/Center of Development (EPD-M) - Rio de Janeiro/RJ
Job description
**About Abbott**
A Abbott is a global leader in health, developing innovative science to improve people's health. We are always looking to the future, anticipating changes in science and medical technologies.
**Working at Abbott**
In Abbott, you can do important work, grow and learn, take care of yourself and your family, be yourself, and live a full life. You will have access to:
+ Career development in an international company where it is possible to grow in the career of your dreams
+ Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount for buying Abbott shares, among others.
+ A globally recognized company as a great place to work in dozens of countries and named one of the most admired companies in the world by Fortune magazine.
+ Among the best large companies to work for, as well as one of the best places to work for mothers who work, executives, and scientists.
+ Flexible working policies that allow a healthy balance between personal life and professional life.
+ An environment where each person is heard and valued.
**Job Description:**
+ Technically contribute to the feasibility stage of new projects;
+ Develop new products, formulations, and manufacturing processes promoting the increase in the company's portfolio, according to established policies and procedures within the company.
+ Document all development stages of a new product so that necessary information is present in standardized and official documents;
+ Start developing a new product with a rational and standard development process based on science and research, aiming at quality in the development process to mitigate future routine problems, using concepts of 'Quality by Design' and 'DoE' and 'PAT';
+ Promote adequate support to the Production, Packaging, NPI, and Quality Control departments when transferring these areas, supporting the MS&T area;
+ Conduct previous studies on IFA (pharmaceutical active ingredient) formulation, excipients, formulas, and processes through bibliographic research, article studies, and patent studies;
+ Research, identify, register, and monitor process and product parameters and critical points, describing the rational since the beginning of development stages in development reports;
+ Test different ranges during the development stage, evaluating the impact on product quality attributes. Monitor them during validation and transfer;
+ Evaluate critically the analytical results obtained at each test performed and propose efficient improvements for better performance of the formulation. Receive, weigh, and separate raw materials and packaging materials;
+ Evaluate critically and in partnership with the Development Galenic Coordination/Gerencia, Analytical Development, and Bioequivalence the previous results to send the pilot batch for equivalence/bioequivalence study and dissolution profile.
+ Develop a new product applying concepts that allow them to comply with current legislation of the country where it will be submitted (protocolized).
+ Prepare technical documentation for submission of new registrations in partnership with the Regulatory Department and Analytical Development, aiming to meet the requirements of current legislation.
+ Make all necessary technical information available for launching a new product, such as: product structures, manufacturing procedures, packaging, specifications of raw materials, granules, intermediates, and finished products, shelf life, as well as critical process parameters, quality attributes, and target profiles;
+ Perform all activities related to Galenic Development according to updated POs.
+ Ensure standardization of activities related to the sector through the preparation and/or revision of Operational Procedures (OP).
+ Ensure that the Galenic area is always in accordance with quality system norms and EHS.
+ Ensure treatment of actions from the quality system originating from audits and monitoring performed by the Quality Assurance team.
+ Know potential risks present in new activities before work begins.
+ Conduct actions and decisions under responsibility for the position, respecting the company's Commercial Conduct Code.
+ Be organized, proactive, and present a sense of ownership in conducting projects and designated activities by the coordination/gerência of the area.
**Required Qualifications:**
+ University degree: Superior complete in Pharmacy,
+ Desired Specialization, Master's or Doctorate in the field of Development of Formulation and Pharmaceutical Processes.
**Preferred Qualifications:**
+ More than 2 years of experience in developing new products in the pharmaceutical industry.
+ Advanced English, Spanish desired
+ With experience: in developing new products in the pharmaceutical industry
+ With knowledge: application of QbD concepts, considering risk analysis, DoE and PAT in developing new products in the pharmaceutical industry. Knowledge of current legislation.
Candidate now (https://www.jobs.abbott/)
Follow your career aspirations in various opportunities at Abbott, a company that can help you build your future and live life to the fullest. Abbott is a company that offers equal opportunities to its collaborators, being committed to diversity.
Connect with us on www.abbottbrasil.com.br and stay in touch with us through Facebook/Abbott Brasil (https://www.facebook.com/AbbottBrasil), follow us on LinkedIn (https://www.linkedin.com/company/abbott-/) and Twitter @AbbottNews (https://twitter.com/AbbottNews).
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email [email protected]
A Abbott is a global leader in health, developing innovative science to improve people's health. We are always looking to the future, anticipating changes in science and medical technologies.
**Working at Abbott**
In Abbott, you can do important work, grow and learn, take care of yourself and your family, be yourself, and live a full life. You will have access to:
+ Career development in an international company where it is possible to grow in the career of your dreams
+ Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount for buying Abbott shares, among others.
+ A globally recognized company as a great place to work in dozens of countries and named one of the most admired companies in the world by Fortune magazine.
+ Among the best large companies to work for, as well as one of the best places to work for mothers who work, executives, and scientists.
+ Flexible working policies that allow a healthy balance between personal life and professional life.
+ An environment where each person is heard and valued.
**Job Description:**
+ Technically contribute to the feasibility stage of new projects;
+ Develop new products, formulations, and manufacturing processes promoting the increase in the company's portfolio, according to established policies and procedures within the company.
+ Document all development stages of a new product so that necessary information is present in standardized and official documents;
+ Start developing a new product with a rational and standard development process based on science and research, aiming at quality in the development process to mitigate future routine problems, using concepts of 'Quality by Design' and 'DoE' and 'PAT';
+ Promote adequate support to the Production, Packaging, NPI, and Quality Control departments when transferring these areas, supporting the MS&T area;
+ Conduct previous studies on IFA (pharmaceutical active ingredient) formulation, excipients, formulas, and processes through bibliographic research, article studies, and patent studies;
+ Research, identify, register, and monitor process and product parameters and critical points, describing the rational since the beginning of development stages in development reports;
+ Test different ranges during the development stage, evaluating the impact on product quality attributes. Monitor them during validation and transfer;
+ Evaluate critically the analytical results obtained at each test performed and propose efficient improvements for better performance of the formulation. Receive, weigh, and separate raw materials and packaging materials;
+ Evaluate critically and in partnership with the Development Galenic Coordination/Gerencia, Analytical Development, and Bioequivalence the previous results to send the pilot batch for equivalence/bioequivalence study and dissolution profile.
+ Develop a new product applying concepts that allow them to comply with current legislation of the country where it will be submitted (protocolized).
+ Prepare technical documentation for submission of new registrations in partnership with the Regulatory Department and Analytical Development, aiming to meet the requirements of current legislation.
+ Make all necessary technical information available for launching a new product, such as: product structures, manufacturing procedures, packaging, specifications of raw materials, granules, intermediates, and finished products, shelf life, as well as critical process parameters, quality attributes, and target profiles;
+ Perform all activities related to Galenic Development according to updated POs.
+ Ensure standardization of activities related to the sector through the preparation and/or revision of Operational Procedures (OP).
+ Ensure that the Galenic area is always in accordance with quality system norms and EHS.
+ Ensure treatment of actions from the quality system originating from audits and monitoring performed by the Quality Assurance team.
+ Know potential risks present in new activities before work begins.
+ Conduct actions and decisions under responsibility for the position, respecting the company's Commercial Conduct Code.
+ Be organized, proactive, and present a sense of ownership in conducting projects and designated activities by the coordination/gerência of the area.
**Required Qualifications:**
+ University degree: Superior complete in Pharmacy,
+ Desired Specialization, Master's or Doctorate in the field of Development of Formulation and Pharmaceutical Processes.
**Preferred Qualifications:**
+ More than 2 years of experience in developing new products in the pharmaceutical industry.
+ Advanced English, Spanish desired
+ With experience: in developing new products in the pharmaceutical industry
+ With knowledge: application of QbD concepts, considering risk analysis, DoE and PAT in developing new products in the pharmaceutical industry. Knowledge of current legislation.
Candidate now (https://www.jobs.abbott/)
Follow your career aspirations in various opportunities at Abbott, a company that can help you build your future and live life to the fullest. Abbott is a company that offers equal opportunities to its collaborators, being committed to diversity.
Connect with us on www.abbottbrasil.com.br and stay in touch with us through Facebook/Abbott Brasil (https://www.facebook.com/AbbottBrasil), follow us on LinkedIn (https://www.linkedin.com/company/abbott-/) and Twitter @AbbottNews (https://twitter.com/AbbottNews).
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email [email protected]
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Company information
- Company
- Abbott
- Location
-
Brasil, Sudeste, Estado do Rio de Janeiro, Rio de Janeiro
Brazil - Posted
- 7 months ago
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