Site Manager External Manufacturing
The PositionThe Site Manager External Manufacturing acts as the primary contact and relationship manager to specified partners or sites for the entire relationship.
Their core business is to handle multiple partners with low/medium/high complexity within one or cross-material groups/cross chapters/cross-partner sites and multiple and/or special technologies depending on experience.
They will on request act as a mentor for managing partners.
Additionally, they manage multiple simple/complex Tech transfers (project management) or simple/complex multiple cross-function projects also over longer periods if necessary or Lead/Support Due diligence/Sourcing projects as required and manage relationships beyond PTS/PT.
They could also lead complex E2E squads.
In the case of development focus the Site Manager External Manufacturing handles multiple low/medium/high complexity CMC projects across technologies (SM and LM)/Life Cycle (Development to commercial) depending on experience.
Can lead complex development squads.
They act as the primary contact and relationship manager to a specified partner(s/site(s)) for a specific molecule.
Your ImpactLeading cross-functional project teams for development programs and/or joint management teams for pipeline and commercial products during life cycle phases (i.
e.
selection,implementation/management and decommissioning) at one or more CDMOs (Contract Development and Manufacturing Organizations)Being accountable for all operational CDMO activities:
assure product development and routine supply/clinical supply with production and QC activities during product life cycle and decommissioning, manage budget monitors the CDMO's performance and coordinates risk mitigation activitiesEvaluating, designing, implementing and maintaining tailored development and manufacturing solutions globally to broaden and accelerate patient access to our medicines in alignment with the product strategy teams and/or the product development teams.
Consider sustainability aspects for the setups.
Establishing, coaching and leading cross-functional/ international project and governance teams consisting of Roche global functions, Roche local functions and external partner companies.
With representatives of e.
g.
Quality, SHE, MSAT, ASAT, Material Management, Engineering, Validation, Registration, Process Development, Packaging Development, Procurement, Legal, Tax, Pricing, Partnering, Market Development and other functions as appropriate.
Ensuring that GMP, Quality, SHE (Safety Health and Environment), product integrity, and businesscompliance standards of Roche are sustainably met by our partners.
And that objectives and plans are aligned with Roche's commercial and manufacturing strategy and plans.
Acting as the primary contact and relationship manager with the specified CDMO(s) for the entirerelationship.
Develop and promote strong relationships with CDMOs/license partners by establishing and leading governance teams to contribute to business decisions and developmentProviding manufacturing knowledge to our partners by Developing strong relationships with internal customers and key supporting functions including according to scope Pharma Development Teams (PDT), Technical Development Teams (TDT), Technical Product Teams (TPT), PTT (gMSAT and GE) and Site Leadership teams to realize product-specific strategies and ensure robust manufacturing and testing solutionsWho You Are You have a minimum Bachelor's in the relevant Engineering or Life Sciences field discipline required.
An advanced degree (MBA, MS, or PhD) desired You have 10
years' experience successfully working in an operations environment, with at least 5 years of managing large, complex cross-functional projects or operational units You have experience working with Contract Manufacturers desired with overall knowledge of DS and DP development, synthetic or biotechnical DS manufacturing, solids or sterile DP commercial manufacturing, device development and manufacturing as well as secondary packaging in a GMP-regulated environment.
Previous experience in technology, manufacturing, quality or supply chain roles is desiredYou also have 3
years' experience in managing direct reports or equivalent experience in leading cross-functional projects or matrix teamsYou built strong cross-functional leadership skills and the ability to collaborate and communicate at different hierarchy levels You are also able ability to operate with a high level of integrity, holding our business partners accountable for the same behaviour, in compliance with the Roche Code of Conduct Excellent written, oral and interpersonal communications and presentation skills in English (preferably in a second language as well) Required competenciesWe expect this person to demonstrate the following competenciesStrategic Agility Maintaining focus on a long-term strategy while successfully adapting to changing environmental conditionsProviding clarity and focus on a few key prioritiesAchieving Results Delivering superior results by trusting and empowering resilient, high-impact teams You are self-driven, able to focus on key drivers and orchestrate multiple activities at once Feedback and Coaching Acting as a mentor, helping others to develop and advance in their careersEncouraging appropriate risk-taking to develop individuals through challenging stretch assignments The position may require up to 25% domestic and international travel.
Relocation benefits will not be available for this role.
The expected salary range for this position based on the primary location of South San Francisco, CA is $138,300 and $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.
BenefitsGenentech 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:
202403-107864Date posted :
2024-03-29Profession:
Manufacturing & EngineeringEmployment type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
Their core business is to handle multiple partners with low/medium/high complexity within one or cross-material groups/cross chapters/cross-partner sites and multiple and/or special technologies depending on experience.
They will on request act as a mentor for managing partners.
Additionally, they manage multiple simple/complex Tech transfers (project management) or simple/complex multiple cross-function projects also over longer periods if necessary or Lead/Support Due diligence/Sourcing projects as required and manage relationships beyond PTS/PT.
They could also lead complex E2E squads.
In the case of development focus the Site Manager External Manufacturing handles multiple low/medium/high complexity CMC projects across technologies (SM and LM)/Life Cycle (Development to commercial) depending on experience.
Can lead complex development squads.
They act as the primary contact and relationship manager to a specified partner(s/site(s)) for a specific molecule.
Your ImpactLeading cross-functional project teams for development programs and/or joint management teams for pipeline and commercial products during life cycle phases (i.
e.
selection,implementation/management and decommissioning) at one or more CDMOs (Contract Development and Manufacturing Organizations)Being accountable for all operational CDMO activities:
assure product development and routine supply/clinical supply with production and QC activities during product life cycle and decommissioning, manage budget monitors the CDMO's performance and coordinates risk mitigation activitiesEvaluating, designing, implementing and maintaining tailored development and manufacturing solutions globally to broaden and accelerate patient access to our medicines in alignment with the product strategy teams and/or the product development teams.
Consider sustainability aspects for the setups.
Establishing, coaching and leading cross-functional/ international project and governance teams consisting of Roche global functions, Roche local functions and external partner companies.
With representatives of e.
g.
Quality, SHE, MSAT, ASAT, Material Management, Engineering, Validation, Registration, Process Development, Packaging Development, Procurement, Legal, Tax, Pricing, Partnering, Market Development and other functions as appropriate.
Ensuring that GMP, Quality, SHE (Safety Health and Environment), product integrity, and businesscompliance standards of Roche are sustainably met by our partners.
And that objectives and plans are aligned with Roche's commercial and manufacturing strategy and plans.
Acting as the primary contact and relationship manager with the specified CDMO(s) for the entirerelationship.
Develop and promote strong relationships with CDMOs/license partners by establishing and leading governance teams to contribute to business decisions and developmentProviding manufacturing knowledge to our partners by Developing strong relationships with internal customers and key supporting functions including according to scope Pharma Development Teams (PDT), Technical Development Teams (TDT), Technical Product Teams (TPT), PTT (gMSAT and GE) and Site Leadership teams to realize product-specific strategies and ensure robust manufacturing and testing solutionsWho You Are You have a minimum Bachelor's in the relevant Engineering or Life Sciences field discipline required.
An advanced degree (MBA, MS, or PhD) desired You have 10
years' experience successfully working in an operations environment, with at least 5 years of managing large, complex cross-functional projects or operational units You have experience working with Contract Manufacturers desired with overall knowledge of DS and DP development, synthetic or biotechnical DS manufacturing, solids or sterile DP commercial manufacturing, device development and manufacturing as well as secondary packaging in a GMP-regulated environment.
Previous experience in technology, manufacturing, quality or supply chain roles is desiredYou also have 3
years' experience in managing direct reports or equivalent experience in leading cross-functional projects or matrix teamsYou built strong cross-functional leadership skills and the ability to collaborate and communicate at different hierarchy levels You are also able ability to operate with a high level of integrity, holding our business partners accountable for the same behaviour, in compliance with the Roche Code of Conduct Excellent written, oral and interpersonal communications and presentation skills in English (preferably in a second language as well) Required competenciesWe expect this person to demonstrate the following competenciesStrategic Agility Maintaining focus on a long-term strategy while successfully adapting to changing environmental conditionsProviding clarity and focus on a few key prioritiesAchieving Results Delivering superior results by trusting and empowering resilient, high-impact teams You are self-driven, able to focus on key drivers and orchestrate multiple activities at once Feedback and Coaching Acting as a mentor, helping others to develop and advance in their careersEncouraging appropriate risk-taking to develop individuals through challenging stretch assignments The position may require up to 25% domestic and international travel.
Relocation benefits will not be available for this role.
The expected salary range for this position based on the primary location of South San Francisco, CA is $138,300 and $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.
BenefitsGenentech 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:
202403-107864Date posted :
2024-03-29Profession:
Manufacturing & EngineeringEmployment type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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