Senior Manager, Pharmaceutical Development
Job Id:
KK_1322077_1674749546Apply NowPosition:
Senior Manager, Pharmaceutical DevelopmentReports to:
Senior Director, Head of Pharm Dev & TDTLLocation:
REMOTE (PST)Duration:
3 MonthsOur client is in pursuit of groundbreaking science is accomplished through developing a pipeline agnostic to drug delivery technology, that encompasses proteins, peptides, oligos, and small molecule therapeutics, for systemic and local administration.
Position
Summary:
This is a scientific role that develops and executes formulation protocols with contract service providers or the internal lab, to support a comprehensive CMC portfolio.
This role will interact extensively with research and development members within CMC.
The role requires product development expertise in biotechnology, coupled with thorough understanding of associated analytical tools, regulatory and quality awareness, and good organizational skills.
Must haves:
Pharmaceutics formulation development, preformulation, excipient studies, injectables and ophthalmic products, test articles for nonclinical studies knowledge of analytical testing applicable to product development in early-stage CMC CMC regulatory experience in phase 1 CMC coordination, protocol and report review, attention to detail, versatile and flexibility to support routine GMP tasks as well as technical development assessments Remote ok, West coast based preferable Key Responsibilities Include:
This is a subject matter expert role that will support contract service providers to develop formulation protocols and analytical procedures enabling the stage-appropriate production and characterization of the molecular candidates in the early-stage portfolio.
The scientist will contribute to preformulation and formulation development, characterization and stability of complex drugs, including liquid and lyophilized formulations for parenteral and ophthalmic administration.
The role requires to contribute to development of analytical tools required to demonstrate the purity and stabitiy of the biological entities, as well as interpretation of data for evaluation of product consistency, for biologics and small molecule therapeutics.
Contributes to the evaluation of critical process parameters that will impact critical quality attributes.
Contributes to the development of the quality target product profile.
This role requires to demonstrate team leadership skills and may be asked to represent CMC at the project team, and to lead other scientists within the CMC function.
The SME may contribute to authoring or reviewing of CMC regulatory documents for global submissions.
With the support of project management, the role may be required to effectively manage CMC Team meetings using effective PM tools and systems to track agreed objectives, timelines and budget Promote a culture of collaboration, cooperation, effective communication and cross-functional problem-solving to become a high-performing team.
KK_1322077_1674749546Apply Now Recommended Skills Administration Analytical Analytical Procedures Assessments Attention To Detail Biology Estimated Salary: $20 to $28 per hour based on qualifications.
KK_1322077_1674749546Apply NowPosition:
Senior Manager, Pharmaceutical DevelopmentReports to:
Senior Director, Head of Pharm Dev & TDTLLocation:
REMOTE (PST)Duration:
3 MonthsOur client is in pursuit of groundbreaking science is accomplished through developing a pipeline agnostic to drug delivery technology, that encompasses proteins, peptides, oligos, and small molecule therapeutics, for systemic and local administration.
Position
Summary:
This is a scientific role that develops and executes formulation protocols with contract service providers or the internal lab, to support a comprehensive CMC portfolio.
This role will interact extensively with research and development members within CMC.
The role requires product development expertise in biotechnology, coupled with thorough understanding of associated analytical tools, regulatory and quality awareness, and good organizational skills.
Must haves:
Pharmaceutics formulation development, preformulation, excipient studies, injectables and ophthalmic products, test articles for nonclinical studies knowledge of analytical testing applicable to product development in early-stage CMC CMC regulatory experience in phase 1 CMC coordination, protocol and report review, attention to detail, versatile and flexibility to support routine GMP tasks as well as technical development assessments Remote ok, West coast based preferable Key Responsibilities Include:
This is a subject matter expert role that will support contract service providers to develop formulation protocols and analytical procedures enabling the stage-appropriate production and characterization of the molecular candidates in the early-stage portfolio.
The scientist will contribute to preformulation and formulation development, characterization and stability of complex drugs, including liquid and lyophilized formulations for parenteral and ophthalmic administration.
The role requires to contribute to development of analytical tools required to demonstrate the purity and stabitiy of the biological entities, as well as interpretation of data for evaluation of product consistency, for biologics and small molecule therapeutics.
Contributes to the evaluation of critical process parameters that will impact critical quality attributes.
Contributes to the development of the quality target product profile.
This role requires to demonstrate team leadership skills and may be asked to represent CMC at the project team, and to lead other scientists within the CMC function.
The SME may contribute to authoring or reviewing of CMC regulatory documents for global submissions.
With the support of project management, the role may be required to effectively manage CMC Team meetings using effective PM tools and systems to track agreed objectives, timelines and budget Promote a culture of collaboration, cooperation, effective communication and cross-functional problem-solving to become a high-performing team.
KK_1322077_1674749546Apply Now Recommended Skills Administration Analytical Analytical Procedures Assessments Attention To Detail Biology Estimated Salary: $20 to $28 per hour based on qualifications.
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