Description:
The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies antibody-drug conjugates (ADCs) neurotoxins and novel biologic formats) from preclinical development through clinical proof of concept across both liquid and lyophilized presentations.
We have an exciting opportunity for a Senior Scientist I to join our team at our Bay Area site in South San Francisco CA to lead end to end formulation and process this role you will plan and execute DoE driven studies assess clinical in-use stability and model degradation pathways. You will establish fit-for-purpose analytical strategies using protein characterization and stability methods such as SEC CE-SDS icIEF HIAC MFI and DLS.
A core focus of the role is building efficiency in drug product manufacturing process operations at scale by devising deploying and optimizing high throughput automated workflows to increase scientific depth and speed across a matrixed cross-site environment.
KEY RESPONSIBILITIES INCLUDE:
- Develop stable and fit-for-purpose liquid and lyophilized drug products through the design and execution of formulation process development and clinical in-use studies.
- Support testing of representative stability lots to support drug substance and drug product shelf-life extension.
- Generate high-quality data based on sound scientific principles and document results in electronic lab notebook.
- Responsible for accumulating and organizing experimental and other relevant data making appropriate recommendations for analyzing and interpreting results and effectively communicating finds to various audiences in scientific presentations technical reports and regulatory documents
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- Drive innovation and continuously enhance capabilities and business processes within the organization.
- Initiate new areas of investigation that are scientifically meaningful reliable and can be incorporated directly into a research or development program.
- Work efficiently and collaboratively in an agile team setting with minimal direction from supervisors.
- Represent the function within cross-functional and cross-site technical teams.
- Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials controlled drug and GxP compliance where applicable.
Qualifications :
- Ph.D. in chemical engineering pharmaceutical sciences material science analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry.
- Strong technical background in protein formulation principles drug product degradation pathways drug product lyophilization drug product manufacturing process unit operations and characterization approaches.
- Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g. SEC CE-SDS icIEF HIAC MFI DLS etc.).
- Technical experience with developing fit-for-purpose analytical characterization techniques is desired.
- Prior experience in the development of protein product formulations is highly desirable.
- Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems.
- Excellent communication and written skills
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
Description:The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies antibody-drug conjugates (ADCs) neurotoxins and novel biologic for...
Description:
The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies antibody-drug conjugates (ADCs) neurotoxins and novel biologic formats) from preclinical development through clinical proof of concept across both liquid and lyophilized presentations.
We have an exciting opportunity for a Senior Scientist I to join our team at our Bay Area site in South San Francisco CA to lead end to end formulation and process this role you will plan and execute DoE driven studies assess clinical in-use stability and model degradation pathways. You will establish fit-for-purpose analytical strategies using protein characterization and stability methods such as SEC CE-SDS icIEF HIAC MFI and DLS.
A core focus of the role is building efficiency in drug product manufacturing process operations at scale by devising deploying and optimizing high throughput automated workflows to increase scientific depth and speed across a matrixed cross-site environment.
KEY RESPONSIBILITIES INCLUDE:
- Develop stable and fit-for-purpose liquid and lyophilized drug products through the design and execution of formulation process development and clinical in-use studies.
- Support testing of representative stability lots to support drug substance and drug product shelf-life extension.
- Generate high-quality data based on sound scientific principles and document results in electronic lab notebook.
- Responsible for accumulating and organizing experimental and other relevant data making appropriate recommendations for analyzing and interpreting results and effectively communicating finds to various audiences in scientific presentations technical reports and regulatory documents
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- Drive innovation and continuously enhance capabilities and business processes within the organization.
- Initiate new areas of investigation that are scientifically meaningful reliable and can be incorporated directly into a research or development program.
- Work efficiently and collaboratively in an agile team setting with minimal direction from supervisors.
- Represent the function within cross-functional and cross-site technical teams.
- Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials controlled drug and GxP compliance where applicable.
Qualifications :
- Ph.D. in chemical engineering pharmaceutical sciences material science analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry.
- Strong technical background in protein formulation principles drug product degradation pathways drug product lyophilization drug product manufacturing process unit operations and characterization approaches.
- Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g. SEC CE-SDS icIEF HIAC MFI DLS etc.).
- Technical experience with developing fit-for-purpose analytical characterization techniques is desired.
- Prior experience in the development of protein product formulations is highly desirable.
- Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems.
- Excellent communication and written skills
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
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