*Remote* - Analytical Development - Associate Director/Director, MSAT
Associate Director/Director, Analytical Development MSAT (Remote)Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector.
Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.
Responsibilities Provide support for the management of outsourced analytical methods across a global network of vendors involved in the manufacturing of commercial and clinical biopharmaceutical drug substances and drug products.
Assist in shaping the strategy and effectively oversee the execution of assay validation, transfer, optimization, and development processes that align with the needs of commercial and clinical manufacturing.
Collaborate with colleagues in Quality and Manufacturing to facilitate the analysis of data related to various testing phases, such as lot release testing, in-process testing, stability testing, stability analysis, characterization, and assay qualification/validation.
Oversee and manage both development and Good Manufacturing Practice (GMP) analytical work conducted in external laboratories.
Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings, including post-approval submissions to US and EU regulatory bodies.
Coordinate efforts with compliance groups, including QC testing, QA, and regulatory teams, to ensure alignment with regulatory standards and quality assurance.
Conduct in-depth analysis and trend evaluation of testing results, presenting findings in a clear and data-driven manner, and proposing actionable solutions based on these insights.
Author and review technical reports and other documentation in a clear and concise manner, ensuring that all information is accurately conveyed.
Qualifications PhD in Analytical Chemistry, Biochemistry, Chemistry, or related area.
7 years of experience, industry is preferred (M.
S.
with significant industry experience will also be considered) Experience in overseeing outsourced analytical tasks within the pharmaceutical development or commercial sector, encompassing method development, validation, and transfer processes.
Knowledgeable about cGMP (current Good Manufacturing Practice) requirements pertaining to the analysis of biopharmaceuticals.
Significant experience in physicochemical methods, with a proven track record of applying these methods in a pharmaceutical or biotechnology setting.
Demonstrated experience in managing both development and GMP work in external analytical labs (or in house manufacturing lab in GMP environment).
Extensive expertise in analytical development and troubleshooting related to biologics, with proficiency in various methodologies such as chromatography, immunoassays, residual analysis, and cell-based assays.
Familiarity with vector and gene therapies is advantageous, although adaptability to new assay modalities is essential.
Possesses a robust scientific mindset and the ability to skilfully interpret data to construct and convey insights into assay and product behaviour.
This proficiency enables the formulation of data-driven proposals and recommendations.
Acquainted with statistical analysis and the principles of statistical process control.
A proactive attitude, capable of addressing challenges effectively, and a willingness to be part of a dynamic, team-oriented environment within a small but expanding biotech company, offering diverse opportunities for personal and professional development.
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.
We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI.
We strive to create a welcoming and inclusive environment for all employees.
Recommended Skills Adaptability Biochemistry Biopharmaceuticals Biotechnology Certified Global Meeting Planner Chromatography Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
external-apply-email-saved').
on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3m3w86d5lznw3nl6h3', 'ExternalApply-j3m3w86d5lznw3nl6h3'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.
Responsibilities Provide support for the management of outsourced analytical methods across a global network of vendors involved in the manufacturing of commercial and clinical biopharmaceutical drug substances and drug products.
Assist in shaping the strategy and effectively oversee the execution of assay validation, transfer, optimization, and development processes that align with the needs of commercial and clinical manufacturing.
Collaborate with colleagues in Quality and Manufacturing to facilitate the analysis of data related to various testing phases, such as lot release testing, in-process testing, stability testing, stability analysis, characterization, and assay qualification/validation.
Oversee and manage both development and Good Manufacturing Practice (GMP) analytical work conducted in external laboratories.
Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings, including post-approval submissions to US and EU regulatory bodies.
Coordinate efforts with compliance groups, including QC testing, QA, and regulatory teams, to ensure alignment with regulatory standards and quality assurance.
Conduct in-depth analysis and trend evaluation of testing results, presenting findings in a clear and data-driven manner, and proposing actionable solutions based on these insights.
Author and review technical reports and other documentation in a clear and concise manner, ensuring that all information is accurately conveyed.
Qualifications PhD in Analytical Chemistry, Biochemistry, Chemistry, or related area.
7 years of experience, industry is preferred (M.
S.
with significant industry experience will also be considered) Experience in overseeing outsourced analytical tasks within the pharmaceutical development or commercial sector, encompassing method development, validation, and transfer processes.
Knowledgeable about cGMP (current Good Manufacturing Practice) requirements pertaining to the analysis of biopharmaceuticals.
Significant experience in physicochemical methods, with a proven track record of applying these methods in a pharmaceutical or biotechnology setting.
Demonstrated experience in managing both development and GMP work in external analytical labs (or in house manufacturing lab in GMP environment).
Extensive expertise in analytical development and troubleshooting related to biologics, with proficiency in various methodologies such as chromatography, immunoassays, residual analysis, and cell-based assays.
Familiarity with vector and gene therapies is advantageous, although adaptability to new assay modalities is essential.
Possesses a robust scientific mindset and the ability to skilfully interpret data to construct and convey insights into assay and product behaviour.
This proficiency enables the formulation of data-driven proposals and recommendations.
Acquainted with statistical analysis and the principles of statistical process control.
A proactive attitude, capable of addressing challenges effectively, and a willingness to be part of a dynamic, team-oriented environment within a small but expanding biotech company, offering diverse opportunities for personal and professional development.
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.
We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI.
We strive to create a welcoming and inclusive environment for all employees.
Recommended Skills Adaptability Biochemistry Biopharmaceuticals Biotechnology Certified Global Meeting Planner Chromatography Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
external-apply-email-saved').
on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3m3w86d5lznw3nl6h3', 'ExternalApply-j3m3w86d5lznw3nl6h3'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
