External CMC Collaboration Lead - Genentech
South San Francisco, CA 94080
About the Job
The PositionRoche’s CDMO Organization interfaces with 80+ contract development and manufacturing organizations (CDMOs) around the world to boost the capacity and capabilities of the supply network as our portfolio evolves
CDMO prioritizes speed, quality and cost with our CDMO partners to deliver clinical materials and 55 product families to more than 70 markets
We serve as a center of excellence that represents 80+ people based in North America and Europe with broad technical experience and a high-performance mindset to deliver on the Pharma Vision for Roche.CDMO is an organization with a purpose driven culture that is built on trust and cooperation, where people are inspired to co-create solutions and develop the capabilities required to deliver our mission.The Opportunity:CDMO has an opening for an External CMC Collaborations Lead (ECCL) to join our team
The main responsibilities for this role include: Ensuring the successful planning and execution of outsourced activities supporting Chemistry Manufacturing Controls (CMC) deliverables for Roche’s clinical pipeline in Biologics/Novel technologies or small molecules to Contract Development and Manufacturing Organizations (CDMOs), Clinical Research Organizations (CROs), and Contract Laboratory Organizations (CLOs)
This position focuses primarily on bioprocessing of large molecules (DS and DP) and associated technologies but can provide support within varying modalities and CMC lifecycles including synthetic molecules and cGMP commercial launch.Enable CDMO capability for Roche via CDMO/CRO/CLOs
Direct, coordinate and own accountability for all CDMO aspects aligning technical, operational, supply chain, quality, SHE and business activities required to select, transfer, start-up and oversee the successful, timely delivery of clinical trial materials (CTM), materials to support clinical program activities, commercial launch activities (if applicable) and other CMC services from our CDMO/CRO/CLOs. Evaluate and implement robust manufacturing solutions at our CDMO/CRO/CLOs to broaden and accelerate patient access to Roche’s medicines. Guide decisions in shaping Roche’s outsourcing strategies to complement in-house development capacity and capabilities
Perform feasibility assessments by evaluating risks, costs, and outsourcing landscape against organizational short term tactical needs and strategic objectives
This will include assessing various global markets and CDMO/CRO/CLOs for manufacturing, development, and analytical testing capabilities and requires aptitude to evaluate capability of CDMOs to support Roche’s network of the future.Support development and commercial launch activities including process validation, analytical method transfers and management of quality events
Develop and negotiate Master Service Agreements (MSA) and Statements of Work (SOW), supportive contracts and/or Purchase Orders in collaboration with Procurement, Legal, and Finance. Conduct due diligence activities for in-licensing of Genentech and Roche Research and Early Development (gRED and pRED) compounds as well as for late stage clinical phase compounds by covering the CMC-outsourcing aspects and CDMO/ CRO/CLO-aspects to include business, CDMO specific aspects of SHE (Safety, Sustainability, Health, Environmental) , CMO capability, for new CDMO/CRO/CLOs for planned or potential future work. Who you are:EDUCATION : BS in a relevant Engineering or Life Sciences field discipline is required
An advanced degree (MBA, MS, or PhD) is desired. EXPERIENCE: Minimum of 8 years of biotech/pharmaceutical industry experience in manufacturing operations, technology transfer, project management, process development is required. Specifically experience working with process development groups along with overall knowledge of clinical manufacturing, regulatory, QA, and cGMP requirements for biological products is preferred for extensive end-to-end outsourcing experience across clinical and commercial lifecycles including late stage clinical and commercial launch programs.MINDSET: This is an on-campus position and the candidate is committed to spending the majority of their work time on campus
Cultivates a culture of diverse and critical thinking with the ability to react and adapt with agility
Embraces complexity and challenging timelines and drives results via empowerment and accountability in a matrix team environment.Travel requirements: This position may require between 10-25% domestic and international travel
Must be able to travel intercontinentally 1-2 times / year.Relocation benefits are not available for this posting.The expected salary range for this position based on the primary location of California is $138,300 to $256,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Benefits#LI-PK1Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us
Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.Job SummaryJob number:
CDMO prioritizes speed, quality and cost with our CDMO partners to deliver clinical materials and 55 product families to more than 70 markets
We serve as a center of excellence that represents 80+ people based in North America and Europe with broad technical experience and a high-performance mindset to deliver on the Pharma Vision for Roche.CDMO is an organization with a purpose driven culture that is built on trust and cooperation, where people are inspired to co-create solutions and develop the capabilities required to deliver our mission.The Opportunity:CDMO has an opening for an External CMC Collaborations Lead (ECCL) to join our team
The main responsibilities for this role include: Ensuring the successful planning and execution of outsourced activities supporting Chemistry Manufacturing Controls (CMC) deliverables for Roche’s clinical pipeline in Biologics/Novel technologies or small molecules to Contract Development and Manufacturing Organizations (CDMOs), Clinical Research Organizations (CROs), and Contract Laboratory Organizations (CLOs)
This position focuses primarily on bioprocessing of large molecules (DS and DP) and associated technologies but can provide support within varying modalities and CMC lifecycles including synthetic molecules and cGMP commercial launch.Enable CDMO capability for Roche via CDMO/CRO/CLOs
Direct, coordinate and own accountability for all CDMO aspects aligning technical, operational, supply chain, quality, SHE and business activities required to select, transfer, start-up and oversee the successful, timely delivery of clinical trial materials (CTM), materials to support clinical program activities, commercial launch activities (if applicable) and other CMC services from our CDMO/CRO/CLOs. Evaluate and implement robust manufacturing solutions at our CDMO/CRO/CLOs to broaden and accelerate patient access to Roche’s medicines. Guide decisions in shaping Roche’s outsourcing strategies to complement in-house development capacity and capabilities
Perform feasibility assessments by evaluating risks, costs, and outsourcing landscape against organizational short term tactical needs and strategic objectives
This will include assessing various global markets and CDMO/CRO/CLOs for manufacturing, development, and analytical testing capabilities and requires aptitude to evaluate capability of CDMOs to support Roche’s network of the future.Support development and commercial launch activities including process validation, analytical method transfers and management of quality events
Develop and negotiate Master Service Agreements (MSA) and Statements of Work (SOW), supportive contracts and/or Purchase Orders in collaboration with Procurement, Legal, and Finance. Conduct due diligence activities for in-licensing of Genentech and Roche Research and Early Development (gRED and pRED) compounds as well as for late stage clinical phase compounds by covering the CMC-outsourcing aspects and CDMO/ CRO/CLO-aspects to include business, CDMO specific aspects of SHE (Safety, Sustainability, Health, Environmental) , CMO capability, for new CDMO/CRO/CLOs for planned or potential future work. Who you are:EDUCATION : BS in a relevant Engineering or Life Sciences field discipline is required
An advanced degree (MBA, MS, or PhD) is desired. EXPERIENCE: Minimum of 8 years of biotech/pharmaceutical industry experience in manufacturing operations, technology transfer, project management, process development is required. Specifically experience working with process development groups along with overall knowledge of clinical manufacturing, regulatory, QA, and cGMP requirements for biological products is preferred for extensive end-to-end outsourcing experience across clinical and commercial lifecycles including late stage clinical and commercial launch programs.MINDSET: This is an on-campus position and the candidate is committed to spending the majority of their work time on campus
Cultivates a culture of diverse and critical thinking with the ability to react and adapt with agility
Embraces complexity and challenging timelines and drives results via empowerment and accountability in a matrix team environment.Travel requirements: This position may require between 10-25% domestic and international travel
Must be able to travel intercontinentally 1-2 times / year.Relocation benefits are not available for this posting.The expected salary range for this position based on the primary location of California is $138,300 to $256,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Benefits#LI-PK1Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us
Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.Job SummaryJob number:
202407-1192
31Date posted : 2024-08-08Profession: Manufacturing & EngineeringEmployment type: Full time
Source : Genentech