Territory: Phoenix South, AZ - Psychiatry Target area for territory is Southern Phoenix and Tuscon - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Scottsdale, Tucson, Yuma and Globe. SUMMARY: Are you a results-driven pharmaceutical sales professional looking to be part of a collaborative, agile and patient-focused organization? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth! As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating "total office" account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university • 4+ years pharmaceutical, healthcare, medical sales or related experience • 2+ years promoting and detailing products in the field of CNS/neuroscience, hospital, medical devices or within a specialty product sales force. • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually • Self-starter, with a strong work ethic and outstanding communication skills • Must be computer literate with proficiency in Microsoft Office software • Must live within 40 miles of territory boundaries • Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder • Previous specialty pharmacy or buy & bill/injectable sales experience • Documented successful sales performance • Ownership and accountability for the development and execution of fully integrated account plans • Strong analytical background, and experience using sales data reporting tools to identify trends • Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals • Experience in product launches • Previous experience working with alliance partners (i.e., co-promotions) • Strong leadership through participation in committees, job rotations, panels and related activities TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. Why Lundbeck Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site . Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site . Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify . .buttontextdc743c14a a{ border: 1px solid transparent; } .buttontextdc743c14a a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.
03/05/2021
Full time
Territory: Phoenix South, AZ - Psychiatry Target area for territory is Southern Phoenix and Tuscon - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Scottsdale, Tucson, Yuma and Globe. SUMMARY: Are you a results-driven pharmaceutical sales professional looking to be part of a collaborative, agile and patient-focused organization? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth! As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating "total office" account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university • 4+ years pharmaceutical, healthcare, medical sales or related experience • 2+ years promoting and detailing products in the field of CNS/neuroscience, hospital, medical devices or within a specialty product sales force. • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually • Self-starter, with a strong work ethic and outstanding communication skills • Must be computer literate with proficiency in Microsoft Office software • Must live within 40 miles of territory boundaries • Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder • Previous specialty pharmacy or buy & bill/injectable sales experience • Documented successful sales performance • Ownership and accountability for the development and execution of fully integrated account plans • Strong analytical background, and experience using sales data reporting tools to identify trends • Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals • Experience in product launches • Previous experience working with alliance partners (i.e., co-promotions) • Strong leadership through participation in committees, job rotations, panels and related activities TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. Why Lundbeck Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site . Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site . Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify . .buttontextdc743c14a a{ border: 1px solid transparent; } .buttontextdc743c14a a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments. This is a remote position, ideally based in the East Coast or Midwest SUMMARY: This position describes the principal clinical person on a project at pre-clinical or early clinical development stages. The projects are likely to combine neurology and psychiatry indications and the key task will be to understand what biology can be targeted by the molecule under development, how this biology can be explored in the clinic and how results of this exploration can lead to an indication selection and to structuring a clinical development program for this indication. The projects will be multi-faceted, and this individual will lead a matrix team. ESSENTIAL FUNCTIONS: Responsible for taking a molecule from the pre-clinical phase to the clinical phase of development Collaborate with research, experimental medicine and other functions to develop a clinical plan for characterization of safety, tolerability and pharmacological action for a new molecule Responsible for designing clinical studies that allow implementation of this clinical development plan and carries overall responsibility for delivering these studies Able to analyze data from clinical studies and to make Go/No Go decisions for explored indications and/or symptoms Leads an early phase multi-disciplined clinical project/study team Contributes to the creation of all required clinical documents, including protocol synopses, clinical study reports, investigator brochures, clinical portions of regulatory documents, such as annual reports, initial clinical research applications, briefing books for regulatory meetings and submission packages. Provides medical monitoring for clinical trials or supervises an external medical monitor if medical monitoring services are outsourced Able to maintain an open, flexible approach to decision making based both on rigorous scientific analyses and Lundbeck business needs REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited MD (Medical Physician) or accredited PhD with prior clinical/clinical research experience within neurology or psychiatry 2+ years of experience in clinical research within an academic or pharmaceutical / biotech setting Ability to lead cross-functional matrix teams in a highly collaborative fashion Evidence of a proactive and creative approach Able to maintain an open, flexible approach to decision making based both on rigorous scientific analyses and business needs Shows the flexibility to work across disease areas within psychiatry and neurology and be open to look at areas beyond their immediate specialization PREFERRED EDUCATION, EXPERIENCE AND SKILLS: MD (Medical Physician) Enthusiastic about learning and exploring new pharmacological and biomarker approaches Pro-active, outgoing, goal-oriented, dynamic, responsible and decisive Team player and able to work independently at the same time Able to maintain a broad overview and keep enough level of detail TRAVEL Willingness/Ability to travel up to 30% domestically and internationally The range displayed is specifically for those potential hires who will work or reside in the state of Colorado, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $160,000 - $200,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site . Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. .buttontextcc992ff0ed1a3b04 a{ border: 1px solid transparent; } .buttontextcc992ff0ed1a3b04 a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.
01/27/2021
Full time
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments. This is a remote position, ideally based in the East Coast or Midwest SUMMARY: This position describes the principal clinical person on a project at pre-clinical or early clinical development stages. The projects are likely to combine neurology and psychiatry indications and the key task will be to understand what biology can be targeted by the molecule under development, how this biology can be explored in the clinic and how results of this exploration can lead to an indication selection and to structuring a clinical development program for this indication. The projects will be multi-faceted, and this individual will lead a matrix team. ESSENTIAL FUNCTIONS: Responsible for taking a molecule from the pre-clinical phase to the clinical phase of development Collaborate with research, experimental medicine and other functions to develop a clinical plan for characterization of safety, tolerability and pharmacological action for a new molecule Responsible for designing clinical studies that allow implementation of this clinical development plan and carries overall responsibility for delivering these studies Able to analyze data from clinical studies and to make Go/No Go decisions for explored indications and/or symptoms Leads an early phase multi-disciplined clinical project/study team Contributes to the creation of all required clinical documents, including protocol synopses, clinical study reports, investigator brochures, clinical portions of regulatory documents, such as annual reports, initial clinical research applications, briefing books for regulatory meetings and submission packages. Provides medical monitoring for clinical trials or supervises an external medical monitor if medical monitoring services are outsourced Able to maintain an open, flexible approach to decision making based both on rigorous scientific analyses and Lundbeck business needs REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited MD (Medical Physician) or accredited PhD with prior clinical/clinical research experience within neurology or psychiatry 2+ years of experience in clinical research within an academic or pharmaceutical / biotech setting Ability to lead cross-functional matrix teams in a highly collaborative fashion Evidence of a proactive and creative approach Able to maintain an open, flexible approach to decision making based both on rigorous scientific analyses and business needs Shows the flexibility to work across disease areas within psychiatry and neurology and be open to look at areas beyond their immediate specialization PREFERRED EDUCATION, EXPERIENCE AND SKILLS: MD (Medical Physician) Enthusiastic about learning and exploring new pharmacological and biomarker approaches Pro-active, outgoing, goal-oriented, dynamic, responsible and decisive Team player and able to work independently at the same time Able to maintain a broad overview and keep enough level of detail TRAVEL Willingness/Ability to travel up to 30% domestically and internationally The range displayed is specifically for those potential hires who will work or reside in the state of Colorado, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $160,000 - $200,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site . Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. .buttontextcc992ff0ed1a3b04 a{ border: 1px solid transparent; } .buttontextcc992ff0ed1a3b04 a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.
Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Late-Stage Development and Production groups. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. SUMMARY: Responsible for leading Formulation Development, Drug Product development, Technology Transfer and Clinical Manufacturing Oversight for biologically derived therapeutics at Lundbeck under cGLP and cGMP guidelines. ESSENTIAL FUNCTIONS: Leads the development of stable formulations (liquid and/or lyophilized) for antibodies. Oversees the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions. Oversees the development of technical transfer protocols and supervises the development and transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities. Participates in vendor selection process supporting Drug Product Manufacturing at CMOs for clinical and commercial programs. Responsible for the technical management of third-party drug product manufacturers. Provides technical oversight for clinical manufacturing activities. Provide technical support for commercial manufacturing activities. Work closely with Analytical, Bioassay, QC and QA partners to assess product quality and product stability. Represent the Drug Product group on CMC Focus Teams and Working Groups Provide organizational leadership in all areas related to formulation, fill & finish work Work collaboratively and cross-functionally with other key leaders to execute on organizational goals. Assign resources according to priority and project needs. Represent the Drug Product group to senior management and All Hands Meetings on a regular basis. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Bachelor's degree and 15+ years of experience in the biopharma industry OR Accredited Master's degree with 12+ years of experience in the biopharma industry OR PhD with 10+ years of experience in the biopharma industry Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products. Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation. Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work. Experience supporting Fill-Finish Process Development, technology transfer and manufacturing oversight of Drug Product CMO partners Excellent written and oral communication, including experience delivering professional internal and external presentations. Demonstrated experience authoring protocols, reports and regulatory filings. Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements. Strong working knowledge of cGMPs and compliance requirements. Prior experience interacting with the FDA during inspections. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: PhD in biology or chemistry-related disciplines and 10+ years industry experience Experience with Pre-Filled Syringe and Autoinjector development is strongly desired TRAVEL Willingness/Ability to travel up to 20% domestically and internationally Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. .buttontextcc992ff0ed1a3b04 a{ border: 1px solid transparent; } .buttontextcc992ff0ed1a3b04 a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.
01/26/2021
Full time
Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Late-Stage Development and Production groups. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. SUMMARY: Responsible for leading Formulation Development, Drug Product development, Technology Transfer and Clinical Manufacturing Oversight for biologically derived therapeutics at Lundbeck under cGLP and cGMP guidelines. ESSENTIAL FUNCTIONS: Leads the development of stable formulations (liquid and/or lyophilized) for antibodies. Oversees the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions. Oversees the development of technical transfer protocols and supervises the development and transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities. Participates in vendor selection process supporting Drug Product Manufacturing at CMOs for clinical and commercial programs. Responsible for the technical management of third-party drug product manufacturers. Provides technical oversight for clinical manufacturing activities. Provide technical support for commercial manufacturing activities. Work closely with Analytical, Bioassay, QC and QA partners to assess product quality and product stability. Represent the Drug Product group on CMC Focus Teams and Working Groups Provide organizational leadership in all areas related to formulation, fill & finish work Work collaboratively and cross-functionally with other key leaders to execute on organizational goals. Assign resources according to priority and project needs. Represent the Drug Product group to senior management and All Hands Meetings on a regular basis. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Bachelor's degree and 15+ years of experience in the biopharma industry OR Accredited Master's degree with 12+ years of experience in the biopharma industry OR PhD with 10+ years of experience in the biopharma industry Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products. Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation. Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work. Experience supporting Fill-Finish Process Development, technology transfer and manufacturing oversight of Drug Product CMO partners Excellent written and oral communication, including experience delivering professional internal and external presentations. Demonstrated experience authoring protocols, reports and regulatory filings. Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements. Strong working knowledge of cGMPs and compliance requirements. Prior experience interacting with the FDA during inspections. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: PhD in biology or chemistry-related disciplines and 10+ years industry experience Experience with Pre-Filled Syringe and Autoinjector development is strongly desired TRAVEL Willingness/Ability to travel up to 20% domestically and internationally Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. .buttontextcc992ff0ed1a3b04 a{ border: 1px solid transparent; } .buttontextcc992ff0ed1a3b04 a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.