Merck
Associate Director, External Manufacturing Operations
Merck, Honolulu, Hawaii, United States, 96814
Merck Associate Director, External Manufacturing Operations Honolulu, Hawaii Apply Now
An opportunity has arisen for an
External Manufacturing Operations Associate Director.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.Based out of the United States, the
ExM Operations Associate Director
is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).Bring energy, knowledge, innovation to carry out the following:Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party’s (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials.Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (“read a site”) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans.Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required.Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI.Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control.Accountable for inventory control. Based on the location of goods (at External Party or at our Company), ensures adequate documentation of material disposition.Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee).Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc.Minimum Qualifications:Bachelor’s degree preferably in the Engineering, Science or Business.Required experience and skills:Minimum 8 years’ experience in commercial / business and manufacturing (sterile operations, quality, technology, planning).At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women’s Network, LEAD or mentoring.Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.Direct Health Authority Audit experience is desirable.Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
RemoteJob Posting End Date:
10/7/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
#J-18808-Ljbffr
An opportunity has arisen for an
External Manufacturing Operations Associate Director.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.Based out of the United States, the
ExM Operations Associate Director
is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).Bring energy, knowledge, innovation to carry out the following:Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party’s (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials.Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (“read a site”) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans.Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required.Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI.Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control.Accountable for inventory control. Based on the location of goods (at External Party or at our Company), ensures adequate documentation of material disposition.Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee).Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc.Minimum Qualifications:Bachelor’s degree preferably in the Engineering, Science or Business.Required experience and skills:Minimum 8 years’ experience in commercial / business and manufacturing (sterile operations, quality, technology, planning).At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women’s Network, LEAD or mentoring.Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.Direct Health Authority Audit experience is desirable.Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
RemoteJob Posting End Date:
10/7/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
#J-18808-Ljbffr