Address
Form of workClinical Supply Chain Manager
Location: Remote
Duration: 9 months with possible extension
Description:
Ideal candidate: Master data ERP system experience, SAP JD Edwards, general Supply Chain with the pharmaceutical industry.
Bachelor’s 5 YOE minimum in the industry.
Responsibilities include:
Support master data activities and analysis related to the client external contract manufacturing network and raw material planning including but not limited to material master data, virtual plant data set up and maintenance, and serialization data as required under the Serialized Product Traceability (SPT) program at client
Serve as a subject matter expert (SME) in master data management, metadata management, and data governance operations
Collect user requirements and co-create dashboards and reports for key performance indicators required to support EPD Success and ensure patient supply
Support Sales & Operations Planning data preparation and reporting
Develop plans and materials to support user adoption and training for master data, KPIs etc. to support EPD business processes.
Maintain EPD training plans and ensure that required Operating Standards are implemented and sustained
Serve as a Supply Chain master data resource and/or representative for special projects and initiatives
Solve complex data-related problems using a variety of technical and analytical skills
Collaborate with CMC team members in defining clinical and commercial manufacturing requirements at CMOs
Participate in the selection process for selecting Clinical and Commercial CMOs.
Prepare requests for proposals and statements of works.
Collaborate with Legal and Finance to negotiate agreements with CMOs.
May lead cross functional Due Diligence teams in assessing CMOs.
Coordinate, oversee and document activities related to manufacturing of clinical and commercial API (i.e. batch record production & review, scheduling production with vendor, etc.)
Identify activities or events that may critically affect the availability of API and act on or relay that information to appropriate level of management
Maintain current, accurate and complete manufacturing files (hard copy & electronic, as appropriate)
Review API or Drug Product shipment requests for accuracy and completeness prior to processing
Support late stage activities including process validation and PAI preparations
Coordinate and document activities surrounding complaints, excursions, or deviations received from sites or vendors
Present metric updates to management and project stakeholders.
Participate in regularly scheduled meetings with partners and vendors
Participate in establishing/updating supply contracts with new vendors and current vendors
Participate on audits of third party suppliers
Handle confidential information and perform duties in strict confidence
Ability to multitask with varying priorities
Other Duties as assigned. Masters Degree Preferred: Bachelor’s in Operations, Materials Management, Finance, Chemistry, Chemical Engineering or a related field.
3 -5 years pharmaceutical/biotech industry experience in manufacturing/Supply Chain management
Process chemistry and API manufacturing experience preferred if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on Drug Product manufacturing
Previous supervisory skills are a plus (management of staff).
Manages staff in CMO’s
Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):
Good knowledge and demonstrated practice of ICH/cGXP Guidelines
Experience with regulatory submissions is a plus
Proficient in Microsoft Outlook, Word & Excel
Prior commercial launch experience desirable
Prior experience with SOX Compliance desirable
Prior experience with use and implementation of ERP systems desirable
Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure
Must be highly organized and possess excellent attention to detail
Must have strong oral, written and interpersonal communication skills
Motivated, self directed, able to work autonomously and have a proven ability to work in a team environ
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience and Previous managerial experience directly managing people and/OR experience leading teams, projects, programs OR directing the allocation of resources
Top 3 Must Have Skill Sets:
Operational Excellence
Master Data
Critical Thinking
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Location: Remote
Duration: 9 months with possible extension
Description:
Ideal candidate: Master data ERP system experience, SAP JD Edwards, general Supply Chain with the pharmaceutical industry.
Bachelor’s 5 YOE minimum in the industry.
Responsibilities include:
Support master data activities and analysis related to the client external contract manufacturing network and raw material planning including but not limited to material master data, virtual plant data set up and maintenance, and serialization data as required under the Serialized Product Traceability (SPT) program at client
Serve as a subject matter expert (SME) in master data management, metadata management, and data governance operations
Collect user requirements and co-create dashboards and reports for key performance indicators required to support EPD Success and ensure patient supply
Support Sales & Operations Planning data preparation and reporting
Develop plans and materials to support user adoption and training for master data, KPIs etc. to support EPD business processes.
Maintain EPD training plans and ensure that required Operating Standards are implemented and sustained
Serve as a Supply Chain master data resource and/or representative for special projects and initiatives
Solve complex data-related problems using a variety of technical and analytical skills
Collaborate with CMC team members in defining clinical and commercial manufacturing requirements at CMOs
Participate in the selection process for selecting Clinical and Commercial CMOs.
Prepare requests for proposals and statements of works.
Collaborate with Legal and Finance to negotiate agreements with CMOs.
May lead cross functional Due Diligence teams in assessing CMOs.
Coordinate, oversee and document activities related to manufacturing of clinical and commercial API (i.e. batch record production & review, scheduling production with vendor, etc.)
Identify activities or events that may critically affect the availability of API and act on or relay that information to appropriate level of management
Maintain current, accurate and complete manufacturing files (hard copy & electronic, as appropriate)
Review API or Drug Product shipment requests for accuracy and completeness prior to processing
Support late stage activities including process validation and PAI preparations
Coordinate and document activities surrounding complaints, excursions, or deviations received from sites or vendors
Present metric updates to management and project stakeholders.
Participate in regularly scheduled meetings with partners and vendors
Participate in establishing/updating supply contracts with new vendors and current vendors
Participate on audits of third party suppliers
Handle confidential information and perform duties in strict confidence
Ability to multitask with varying priorities
Other Duties as assigned. Masters Degree Preferred: Bachelor’s in Operations, Materials Management, Finance, Chemistry, Chemical Engineering or a related field.
3 -5 years pharmaceutical/biotech industry experience in manufacturing/Supply Chain management
Process chemistry and API manufacturing experience preferred if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on Drug Product manufacturing
Previous supervisory skills are a plus (management of staff).
Manages staff in CMO’s
Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):
Good knowledge and demonstrated practice of ICH/cGXP Guidelines
Experience with regulatory submissions is a plus
Proficient in Microsoft Outlook, Word & Excel
Prior commercial launch experience desirable
Prior experience with SOX Compliance desirable
Prior experience with use and implementation of ERP systems desirable
Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure
Must be highly organized and possess excellent attention to detail
Must have strong oral, written and interpersonal communication skills
Motivated, self directed, able to work autonomously and have a proven ability to work in a team environ
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience and Previous managerial experience directly managing people and/OR experience leading teams, projects, programs OR directing the allocation of resources
Top 3 Must Have Skill Sets:
Operational Excellence
Master Data
Critical Thinking
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
