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Posted : Saturday, November 04, 2023 08:46 PM
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer and autoimmune disease.
The company's next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is looking for an exceptional individual to join our growing team as Sr.
Quality Engineer.
This position will report directly to the Manager, Quality Engineering and be responsible for executing and providing quality oversight of commissioning, qualification, and validation activities.
Primary Responsibilities: Lead validation efforts in support of new equipment and systems to keep pace with site capacity and life cycle.
Provide oversight of commissioning, qualification, and validation activities.
Maintain the validation of Equipment, Facilities, Utilities, Computer Systems.
Provide document review and approval of CQV and system life cycle documentation and ensure compliance with procedures.
Support periodic reviews of systems.
Quality oversight on validation/qualification and/or facility/utility/equipment/computer system related deviations, CAPAs, and change controls.
Manage and support vendor qualifications.
Participate in cross functional teams for commissioning of new and existing manufacturing, warehouse and QC testing facilities and equipment.
Provide support as required during audits and regulatory inspections.
Participate in Quality Department driven activities including Operational Excellence initiatives, Internal and External Audits, and Quarterly Management Reviews, as appropriate.
Apply phase appropriate quality and compliance principles to tactical activities.
Perform other duties, as assigned.
Basic Qualifications: High School Diploma or GED with at least six (6) years of experience, Bachelor of Science with two (2) years of experience, or Advanced Degree with zero (0) years of experience or equivalent amount of education and experience Knowledge of industry standards and FDA / EMA /ICH regulations and guidelines Experience in GMP and quality management systems Experience in Facility Design and Improvement and associated validation requirements Experience with validation of temperature-controlled units and smoke studies Ability to work in controlled & classified cleanroom environment requiring donning of cleanroom garments (e.
g.
, gowns, gloves, booties, hoods/masks, etc.
) Must be able to prioritize and develop detailed plans and execute multiple tasks and projects simultaneously Strong analytical, problem solving and critical thinking skills Excellent organizational and time management skills with a high level of attention to detail Strong communication (verbal and written) and interpersonal skills Ability to work independently in a fast-paced small company environment Ability to work weekends, as needed Preferred Qualifications: Associate Degree with seven (7) years of experience, Bachelor of Science with five (5) years of experience, or Advanced Degree with three (3) year of experience or equivalent amount of education and experience Experience with Gene / Cell Therapy drug development Experience with Manufacturing and QC Analytical/Micro equipment and software (e.
g.
, ddPCR, cell counters etc.
) Experience with enterprise computer system validation (e.
g.
, ERP, MES etc.
) At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy.
We believe in offering and maintaining competitive compensation and benefits programs for our employees to attract and retain a talented, highly engaged workforce.
Our compensation programs are focused on fair and equitable pay practices including market based and data supported base pay, an annual performance-based bonus plan, and equity grants (ISO) for new employees.
Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.
Salary Range $119,917—$132,789 USD ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs.
ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
All information will be kept confidential according to EEO guidelines.
The company's next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is looking for an exceptional individual to join our growing team as Sr.
Quality Engineer.
This position will report directly to the Manager, Quality Engineering and be responsible for executing and providing quality oversight of commissioning, qualification, and validation activities.
Primary Responsibilities: Lead validation efforts in support of new equipment and systems to keep pace with site capacity and life cycle.
Provide oversight of commissioning, qualification, and validation activities.
Maintain the validation of Equipment, Facilities, Utilities, Computer Systems.
Provide document review and approval of CQV and system life cycle documentation and ensure compliance with procedures.
Support periodic reviews of systems.
Quality oversight on validation/qualification and/or facility/utility/equipment/computer system related deviations, CAPAs, and change controls.
Manage and support vendor qualifications.
Participate in cross functional teams for commissioning of new and existing manufacturing, warehouse and QC testing facilities and equipment.
Provide support as required during audits and regulatory inspections.
Participate in Quality Department driven activities including Operational Excellence initiatives, Internal and External Audits, and Quarterly Management Reviews, as appropriate.
Apply phase appropriate quality and compliance principles to tactical activities.
Perform other duties, as assigned.
Basic Qualifications: High School Diploma or GED with at least six (6) years of experience, Bachelor of Science with two (2) years of experience, or Advanced Degree with zero (0) years of experience or equivalent amount of education and experience Knowledge of industry standards and FDA / EMA /ICH regulations and guidelines Experience in GMP and quality management systems Experience in Facility Design and Improvement and associated validation requirements Experience with validation of temperature-controlled units and smoke studies Ability to work in controlled & classified cleanroom environment requiring donning of cleanroom garments (e.
g.
, gowns, gloves, booties, hoods/masks, etc.
) Must be able to prioritize and develop detailed plans and execute multiple tasks and projects simultaneously Strong analytical, problem solving and critical thinking skills Excellent organizational and time management skills with a high level of attention to detail Strong communication (verbal and written) and interpersonal skills Ability to work independently in a fast-paced small company environment Ability to work weekends, as needed Preferred Qualifications: Associate Degree with seven (7) years of experience, Bachelor of Science with five (5) years of experience, or Advanced Degree with three (3) year of experience or equivalent amount of education and experience Experience with Gene / Cell Therapy drug development Experience with Manufacturing and QC Analytical/Micro equipment and software (e.
g.
, ddPCR, cell counters etc.
) Experience with enterprise computer system validation (e.
g.
, ERP, MES etc.
) At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy.
We believe in offering and maintaining competitive compensation and benefits programs for our employees to attract and retain a talented, highly engaged workforce.
Our compensation programs are focused on fair and equitable pay practices including market based and data supported base pay, an annual performance-based bonus plan, and equity grants (ISO) for new employees.
Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.
Salary Range $119,917—$132,789 USD ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs.
ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
All information will be kept confidential according to EEO guidelines.
• Phone : NA
• Location : West Hills, CA
• Post ID: 9025443158
