Advantage Technical
Associate Scientist
Advantage Technical, Cambridge, Massachusetts, us, 02140
Job Title:
Senior Associate Scientist, Stability and SpecificationsContract RoleLocation:
OnsitePosition Overview:
The Senior Associate Scientist, Stability and Specifications will play a key role in supporting the stability and specification needs of siRNA drug substances and drug products. This role is essential to ensuring that the products meet regulatory and company standards.Key Responsibilities:Initiate and manage specification change controls within a GMP setting.Contribute to general laboratory operations, including data review and authorship/review of technical documentation.Provide technical support as needed across various operations.Author and review SOPs and protocols in accordance with company and regulatory guidelines.Contribute data to analytical and stability sections of regulatory submissions.Assist in responding to agency requests related to these sections.Assess specifications for both existing and new products.Support the maintenance of platform program specification documents.Required Skills and Qualifications:Education:
BS or MS in Chemistry, Biochemistry, or related disciplines.Experience:
Minimum of 2 years of experience in a cGMP analytical laboratory environment.Technical Skills:
Strong experience with technical documentation, SOPs, and cGMP standards.Proficiency in chemistry and biochemistry, with hands-on laboratory skills.Experience with HPLC, ICH guidelines, and analytical laboratory operations.Ability to contribute to stability studies and regulatory submissions.
Soft Skills:
Must be a team player and adaptable to change.Excellent communication skills with the ability to prepare and present technical information.
Languages:
Proficiency in English (speak, read, write).This position offers an opportunity to contribute to the development of cutting-edge siRNA therapies in a dynamic and supportive environment.
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Senior Associate Scientist, Stability and SpecificationsContract RoleLocation:
OnsitePosition Overview:
The Senior Associate Scientist, Stability and Specifications will play a key role in supporting the stability and specification needs of siRNA drug substances and drug products. This role is essential to ensuring that the products meet regulatory and company standards.Key Responsibilities:Initiate and manage specification change controls within a GMP setting.Contribute to general laboratory operations, including data review and authorship/review of technical documentation.Provide technical support as needed across various operations.Author and review SOPs and protocols in accordance with company and regulatory guidelines.Contribute data to analytical and stability sections of regulatory submissions.Assist in responding to agency requests related to these sections.Assess specifications for both existing and new products.Support the maintenance of platform program specification documents.Required Skills and Qualifications:Education:
BS or MS in Chemistry, Biochemistry, or related disciplines.Experience:
Minimum of 2 years of experience in a cGMP analytical laboratory environment.Technical Skills:
Strong experience with technical documentation, SOPs, and cGMP standards.Proficiency in chemistry and biochemistry, with hands-on laboratory skills.Experience with HPLC, ICH guidelines, and analytical laboratory operations.Ability to contribute to stability studies and regulatory submissions.
Soft Skills:
Must be a team player and adaptable to change.Excellent communication skills with the ability to prepare and present technical information.
Languages:
Proficiency in English (speak, read, write).This position offers an opportunity to contribute to the development of cutting-edge siRNA therapies in a dynamic and supportive environment.
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