Werfenlife SA.
Project Manager - AID
Werfenlife SA., San Diego, California, United States, 92189
CountryUnited StatesAbout the Position
Overview
Werfen
is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.Position Summary
The Project Manager position in R&D is responsible for the effective management of all aspects of medium to large sized projects within the R&D Project Management Team. Projects will primarily focus on the development of new and improved Inova autoimmunity diagnostic products. Also includes projects related to life cycle management of Inova existing portfolio of products. Based on project management experience, effectively uses standard project management tools and processes to ensure successful project deliverables. Works independently and uses decision making judgement based on project management expertise. Performs all work in accordance with Inova standard operating procedures and within Inova's Quality System regulations.Responsibilities
Key AccountabilitiesAs an experienced project manager, leads multiple medium to large sized projects, usually of medium to high complexity, associated with the development of new diagnostic products for immune mediated diseases including but not limited to systemic autoimmune rheumatic disease, autoimmune liver disease, anti-phospholipid syndrome and inflammatory bowel disease.Manages all aspects of complex projects and teams, often including representation from multiple departments and disciplines, to ensure all project deliverables are met. At times will include employees of other Werfen organizations.Effectively creates project plans, teams and communication processes for new projects.Ensure stakeholders are identified and project definition, scope to and goals are clearly documented.Uses standard project management tools and processes to ensure that project requirements, deliverables, deadlines, and schedules meet organizational timelines and resource constraints.Responsible for submitting project deliverables, preparing status reports, and effective communications.Responsible for project resource allocation and budget management associated with assigned projects.Identifies, monitors and makes recommendations to manage and mitigate risks associated with assigned projects.Responsible for effective communications, reports and recommendations associated with assigned projects.Ensures documentation needs are met, including but not limited to user manuals, training materials or other documents for successful implementation of new processes and programs.Responsible for establishing and maintaining the Design History File (DHF), as applicable.Properly verifies the Design Control Records, laboratory notebooks and any associated documentation for all research and development activities, in accordance with Inova's Quality System Regulations (QSR).As applicable, responsible for third party partner or vendor coordination, installation, documentation, validation and training for new equipment, to comply with QSR and ISO requirements.Provides guidance and training to junior members of the Project Management Team.Develops and provides training to other Inova staff on standard project management tools and processes.Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.Reflects the values of Werfen and Inova in the quality of work and in working relationships.Budget ManagedDirect responsibility for managing project budgets.Supports department budget indirectly by managing expenses effectively.Internal Networking/Key Relationships
This position will work closely with all R&D teams, Marketing, Quality and various other departments and staff throughout Inova Diagnostics, to achieve project goals. May include collaboration with other Werfen organizations and staff, and third-party vendors.Effective communicator, both written and verbal.Strong change management orientation.Emotional intelligence, active listening and team focus orientation.Highly organized team focused leadership.Detail and quality focus.Problem resolution and conflict management.Analytical, data orientation.Qualifications
Minimum Education, Experience, Skills and KnowledgeEducationBachelor's degree in life sciences or business required.Project management training highly preferred.Experience5+ years project management experience required, preferable in a research and/or life sciences environment.5+ years laboratory experience required, preferable in life sciences, autoimmunity or medical devices preferred.Skills & KnowledgeProject Management Professional (PMP) certification preferred.Strong understanding of formal project management methodologies.Demonstrated experience in leading multiple project teams of various size and complexity from concept to completion required.Project budget management experience required.Advanced knowledge of Microsoft products, including Microsoft Project required.Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.International Mobility
Not required.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific and product data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone, pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk, hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 50 pounds. The noise level in the work environment will vary but is usually moderate.Travel Requirements
Less than 5% of time.Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.The salary range for this position is currently $115,000 -$160,000. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
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Overview
Werfen
is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.Position Summary
The Project Manager position in R&D is responsible for the effective management of all aspects of medium to large sized projects within the R&D Project Management Team. Projects will primarily focus on the development of new and improved Inova autoimmunity diagnostic products. Also includes projects related to life cycle management of Inova existing portfolio of products. Based on project management experience, effectively uses standard project management tools and processes to ensure successful project deliverables. Works independently and uses decision making judgement based on project management expertise. Performs all work in accordance with Inova standard operating procedures and within Inova's Quality System regulations.Responsibilities
Key AccountabilitiesAs an experienced project manager, leads multiple medium to large sized projects, usually of medium to high complexity, associated with the development of new diagnostic products for immune mediated diseases including but not limited to systemic autoimmune rheumatic disease, autoimmune liver disease, anti-phospholipid syndrome and inflammatory bowel disease.Manages all aspects of complex projects and teams, often including representation from multiple departments and disciplines, to ensure all project deliverables are met. At times will include employees of other Werfen organizations.Effectively creates project plans, teams and communication processes for new projects.Ensure stakeholders are identified and project definition, scope to and goals are clearly documented.Uses standard project management tools and processes to ensure that project requirements, deliverables, deadlines, and schedules meet organizational timelines and resource constraints.Responsible for submitting project deliverables, preparing status reports, and effective communications.Responsible for project resource allocation and budget management associated with assigned projects.Identifies, monitors and makes recommendations to manage and mitigate risks associated with assigned projects.Responsible for effective communications, reports and recommendations associated with assigned projects.Ensures documentation needs are met, including but not limited to user manuals, training materials or other documents for successful implementation of new processes and programs.Responsible for establishing and maintaining the Design History File (DHF), as applicable.Properly verifies the Design Control Records, laboratory notebooks and any associated documentation for all research and development activities, in accordance with Inova's Quality System Regulations (QSR).As applicable, responsible for third party partner or vendor coordination, installation, documentation, validation and training for new equipment, to comply with QSR and ISO requirements.Provides guidance and training to junior members of the Project Management Team.Develops and provides training to other Inova staff on standard project management tools and processes.Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.Reflects the values of Werfen and Inova in the quality of work and in working relationships.Budget ManagedDirect responsibility for managing project budgets.Supports department budget indirectly by managing expenses effectively.Internal Networking/Key Relationships
This position will work closely with all R&D teams, Marketing, Quality and various other departments and staff throughout Inova Diagnostics, to achieve project goals. May include collaboration with other Werfen organizations and staff, and third-party vendors.Effective communicator, both written and verbal.Strong change management orientation.Emotional intelligence, active listening and team focus orientation.Highly organized team focused leadership.Detail and quality focus.Problem resolution and conflict management.Analytical, data orientation.Qualifications
Minimum Education, Experience, Skills and KnowledgeEducationBachelor's degree in life sciences or business required.Project management training highly preferred.Experience5+ years project management experience required, preferable in a research and/or life sciences environment.5+ years laboratory experience required, preferable in life sciences, autoimmunity or medical devices preferred.Skills & KnowledgeProject Management Professional (PMP) certification preferred.Strong understanding of formal project management methodologies.Demonstrated experience in leading multiple project teams of various size and complexity from concept to completion required.Project budget management experience required.Advanced knowledge of Microsoft products, including Microsoft Project required.Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.International Mobility
Not required.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific and product data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone, pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk, hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 50 pounds. The noise level in the work environment will vary but is usually moderate.Travel Requirements
Less than 5% of time.Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.The salary range for this position is currently $115,000 -$160,000. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
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