Manager, Analytical Development (Cell/Gene Therapies)
SoluStaff is actively recruiting an Analytical Development Manager for its client, a cutting edge novel immunotherapy company in Philadelphia.
The Analytical Development Manager will support all lab activities involving projects and documentation performed internally and externally relating to the evaluation of viral vector and cell product platforms.
This support includes process implementation, assay and protocol development, scheduling and performing assays, reviewing of results, aid in verification, qualification, and technical transfer, authoring SOP, protocol, and reports.
Candidates should be detail oriented, have some knowledge for technical writing, and should exercise judgment and maintain a high level of compliance with applicable standards and procedures.
This individual is expected to manage analytical staff and help improve and develop systems within the analytical department.
The Analytical Development Manager is required, as needed, to design and conduct testing using techniques for cell culture, flow cytometry, and cell-based potency assays.
Knowledge of molecular biology, virology, chemical analyses, and vector potency assay will be plus.
The position reports to the Senior Manager of Analytical Development and works in close collaboration with colleagues in Research, Process Development, Quality Control, Manufacturing, Quality Assurance, Regulatory and other areas.
The successful candidate will also be responsible for working with members of cross-functional teams in support of outside contract development and manufacturing organizations.
This is an organization that values diversity, honesty and respect while maintaining the highest moral and ethical integrity.
It is an opportunity to take a leadership position alongside a tightly integrated team with a passion for advancing the field of cell and gene therapy focused on improving patient outcomes.
Responsibilities Responsible for resource management and initiating timely resource planning based on production forecasts and business needs Help to establish the growing Analytical Development laboratory, including parameters related to facilities, instruments, processes, and procedures Supervise, coach, and mentor Analytical Development staff in all aspects of their technical development, job performance, career development Manage projects in collaboration with other team members, both internally and at external contract development and manufacturing organizations to evaluate and implement new analytical and process technologies to develop next generation Cell and Gene Therapeutics Participates in investigations related to assay failures, system deficiencies, deviations, equipment, and assay troubleshooting Lead, schedule, and execute laboratory studies for development, optimization, and manufacturing of vector and cell product including design, planning, execution, analysis, and reporting Develop, execute, technical transfer of analytical methods Perform routine testing using analytical techniques for cell culture, flow cytometry, cell-based potency, and other analytical assay types Write and conduct routine assays in compliance with Carisma Standard Operating Procedures Manage samples inventory, raw materials, and reference standards.
Participates in transferring methods and procedures for new assignments as required Participate in the test method review process, including escalation of issues and maintain timelines of reporting Author and review protocols, technical reports, regulatory source documents and memos to summarize experiments and support investigations Support Regulatory submissions and Quality Assurance with technical content and expertise Appropriately analyze data, interpret results, maintain and review laboratory notebook and logbook; prepare and deliver presentations at team meetings Interact with internal cross-functional team members including Research, Process Development, Quality Control, Manufacturing, Nonclinical, Clinical, Quality Assurance, Regulatory, and Legal Work effectively in a team environment to meet project timelines and objectives Occasional travel may be required Perform other duties as assigned Requirements A degree in biology, biochemistry, chemical/bioengineering, cell biology, immunology, virology or related discipline and BS with 10
years of relevant experience MS with 6
years of relevant experience PhD with 2
years of relevant experience Biopharmaceutical industry experience in analytical assay development, GLP/GMP testing facility, or research and discovery Personnel management experience Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees.
Able to manage, coach and mentor junior employees to success.
Effective personal organization and time management skills A strong background in cell culture and cell-based analytical method, potency assays, flow cytometry, killing, phagocytosis, cytotoxicity with expectations for significant expertise developing, optimizing, verification and qualification of assays with multiple technologies Panel design, troubleshooting, and provide training Proven ability to critically analyze data and interpret results Experience authoring and reviewing written records of work in the form of laboratory notebooks (paper or electronic), SOPs, equipment operation, and reports Proven ability to thrive in a collaborative team environment:
strong oral and written communication skills, interpersonal skills and a helpful team spirit Able to read, comprehend, and make appropriate alterations to documents such as test method, SOPs, reports, etc.
Proficiency with Microsoft Excel and other statistical analysis software for analyzing and presenting data Ability to function in a rapidly changing environment and balance multiple priorities simultaneously Highest moral and ethical integrity A desire and willingness to learn, adaptability, and a can do attitude Benefits Health Care Plan (Medical, Dental & Vision) 401k Matched Retirement Plan Paid Time Off (Vacation, Sick & Public Holidays) Recommended Skills Adaptability Biochemistry Biological Engineering Biology Biopharmaceuticals Business Requirements Estimated Salary: $20 to $28 per hour based on qualifications.
The Analytical Development Manager will support all lab activities involving projects and documentation performed internally and externally relating to the evaluation of viral vector and cell product platforms.
This support includes process implementation, assay and protocol development, scheduling and performing assays, reviewing of results, aid in verification, qualification, and technical transfer, authoring SOP, protocol, and reports.
Candidates should be detail oriented, have some knowledge for technical writing, and should exercise judgment and maintain a high level of compliance with applicable standards and procedures.
This individual is expected to manage analytical staff and help improve and develop systems within the analytical department.
The Analytical Development Manager is required, as needed, to design and conduct testing using techniques for cell culture, flow cytometry, and cell-based potency assays.
Knowledge of molecular biology, virology, chemical analyses, and vector potency assay will be plus.
The position reports to the Senior Manager of Analytical Development and works in close collaboration with colleagues in Research, Process Development, Quality Control, Manufacturing, Quality Assurance, Regulatory and other areas.
The successful candidate will also be responsible for working with members of cross-functional teams in support of outside contract development and manufacturing organizations.
This is an organization that values diversity, honesty and respect while maintaining the highest moral and ethical integrity.
It is an opportunity to take a leadership position alongside a tightly integrated team with a passion for advancing the field of cell and gene therapy focused on improving patient outcomes.
Responsibilities Responsible for resource management and initiating timely resource planning based on production forecasts and business needs Help to establish the growing Analytical Development laboratory, including parameters related to facilities, instruments, processes, and procedures Supervise, coach, and mentor Analytical Development staff in all aspects of their technical development, job performance, career development Manage projects in collaboration with other team members, both internally and at external contract development and manufacturing organizations to evaluate and implement new analytical and process technologies to develop next generation Cell and Gene Therapeutics Participates in investigations related to assay failures, system deficiencies, deviations, equipment, and assay troubleshooting Lead, schedule, and execute laboratory studies for development, optimization, and manufacturing of vector and cell product including design, planning, execution, analysis, and reporting Develop, execute, technical transfer of analytical methods Perform routine testing using analytical techniques for cell culture, flow cytometry, cell-based potency, and other analytical assay types Write and conduct routine assays in compliance with Carisma Standard Operating Procedures Manage samples inventory, raw materials, and reference standards.
Participates in transferring methods and procedures for new assignments as required Participate in the test method review process, including escalation of issues and maintain timelines of reporting Author and review protocols, technical reports, regulatory source documents and memos to summarize experiments and support investigations Support Regulatory submissions and Quality Assurance with technical content and expertise Appropriately analyze data, interpret results, maintain and review laboratory notebook and logbook; prepare and deliver presentations at team meetings Interact with internal cross-functional team members including Research, Process Development, Quality Control, Manufacturing, Nonclinical, Clinical, Quality Assurance, Regulatory, and Legal Work effectively in a team environment to meet project timelines and objectives Occasional travel may be required Perform other duties as assigned Requirements A degree in biology, biochemistry, chemical/bioengineering, cell biology, immunology, virology or related discipline and BS with 10
years of relevant experience MS with 6
years of relevant experience PhD with 2
years of relevant experience Biopharmaceutical industry experience in analytical assay development, GLP/GMP testing facility, or research and discovery Personnel management experience Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees.
Able to manage, coach and mentor junior employees to success.
Effective personal organization and time management skills A strong background in cell culture and cell-based analytical method, potency assays, flow cytometry, killing, phagocytosis, cytotoxicity with expectations for significant expertise developing, optimizing, verification and qualification of assays with multiple technologies Panel design, troubleshooting, and provide training Proven ability to critically analyze data and interpret results Experience authoring and reviewing written records of work in the form of laboratory notebooks (paper or electronic), SOPs, equipment operation, and reports Proven ability to thrive in a collaborative team environment:
strong oral and written communication skills, interpersonal skills and a helpful team spirit Able to read, comprehend, and make appropriate alterations to documents such as test method, SOPs, reports, etc.
Proficiency with Microsoft Excel and other statistical analysis software for analyzing and presenting data Ability to function in a rapidly changing environment and balance multiple priorities simultaneously Highest moral and ethical integrity A desire and willingness to learn, adaptability, and a can do attitude Benefits Health Care Plan (Medical, Dental & Vision) 401k Matched Retirement Plan Paid Time Off (Vacation, Sick & Public Holidays) Recommended Skills Adaptability Biochemistry Biological Engineering Biology Biopharmaceuticals Business Requirements Estimated Salary: $20 to $28 per hour based on qualifications.
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