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h3Overview /h3pMonte Rosa Therapeutics is seeking a hands‑on and highly motivated Contractor - Discovery Cellular Assays to support our Discovery pipeline. The successful candidate will bring strong expertise in mammalian cell culture, cell-line engineering, cellular assay development, and molecular biology. /ppIn this role, you will help advance our...

PurposeEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.Revised responsibilitiesReview batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies.Support deviations, root cause, CAPAs, change control and effectiveness checks.Conduct GMP walkdowns and assess...

PurposeProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.Revised responsibilitiesReview/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.Verify independence from authors/executors and identify unresolved GMP risks.Review DI controls and critical...

h3Purpose /h3ulliEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. /li /ulh3Revised responsibilities /h3ulliReview batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies. /liliSupport deviations, root cause, CAPAs, change control and effectiveness checks....

Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. Purpose Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. Revised responsibilities Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence. Verify...

h3Purpose /h3ulliProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. /li /ulh3Revised responsibilities /h3ulliReview/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence. /liliVerify independence from authors/executors and identify unresolved GMP risks....

Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.PurposeExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.Revised responsibilitiesReconcile system inventory, intended use, GxP impact, ownership and validation status.Develop system-specific...

Purpose Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory. Revised responsibilities Reconcile system inventory, intended use, GxP impact, ownership and validation status. Develop system-specific validation strategies, requirements, risk assessments, traceability, tests and reports proportionate to...

ul liEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. /li /ul h3Purpose /h3 ul liEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. /li /ul h3Revised responsibilities /h3 ul liReview batch records and automation-generated batch exceptions, escalating...

PurposeEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.Revised responsibilitiesReview batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies.Support deviations, root cause, CAPAs, change control and effectiveness checks.Conduct GMP walkdowns and assess...

ul liProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. /li /ul h3Purpose /h3 ul liProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. /li /ul h3Revised responsibilities /h3 ul liReview/challenge scope, risk rankings, test strategy, deviations,...

ulliExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory. /li /ulh3Purpose /h3ulliExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory. /li /ulh3Revised responsibilities /h3ulliReconcile system inventory, intended use, GxP impact, ownership and...

h3Purpose /h3 ul liExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory. /li /ul h3Revised responsibilities /h3 ul liReconcile system inventory, intended use, GxP impact, ownership and validation status. /li liDevelop system-specific validation strategies, requirements, risk assessments, traceability,...

PurposeProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.Revised responsibilitiesReview/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.Verify independence from authors/executors and identify unresolved GMP risks.Review DI controls and critical...

Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. Purpose Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. Revised responsibilities Review batch records and automation-generated batch exceptions, escalating unexplained gaps or...

Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. Purpose Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. Revised responsibilities Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence. Verify...

Purpose Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory. Revised responsibilities Reconcile system inventory, intended use, GxP impact, ownership and validation status. Develop system-specific validation strategies, requirements, risk assessments, traceability, tests and reports proportionate to...

Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.PurposeExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.Revised responsibilitiesReconcile system inventory, intended use, GxP impact, ownership and validation status.Develop system-specific...

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions...

h3Overview /h3pMonte Rosa Therapeutics is seeking a hands-on and highly motivated Contractor – Discovery Cellular Assays to support our Discovery pipeline. The successful candidate will bring strong expertise in mammalian cell culture, cell-line engineering, cellular assay development, and molecular biology. /ppIn this role, you will help advance our...