VetJobs
Director, Small Molecule Process Development - Thousand Oaks, CA
VetJobs, Newbury Park, California, United States, 91320
Director, Small Molecule Process Development
Director, Small Molecule Process Development - Thousand Oaks, CA Let's do this. Let's change the world. In this vital role you will be part of Amgen's Process Development organization, Drug Substance Technologies
Synthetics (DSTS) plays a vital role in developing robust drug substance manufacturing processes to serve patients. Specifically, DSTS is an integrated organization of small molecule process chemists and engineers that is accountable to invent, develop, and deploy drug substance manufacturing processes and technologies to advance Amgen's synthetic and hybrid portfolio. In this role, the Director is responsible for leading a team of process chemists that drive all aspects of commercial process development, process design, process characterization, site selection for commercial manufacturing, and technology transfer for our synthetic portfolio, inclusive of hybrid modalities (e.g., peptides, oligonucleotides and bioconjugates). This is an on-site role based out of our Amgen Thousand Oaks, CA headquarters and reports to the Senior Director of Process Development. Accountable for leading a team of process chemists, ensuring that the DSTS mission and vision are implemented and upheld Accountable to advance a complex and diverse synthetics portfolio of molecules
including small molecules, bioconjugates, ADCs, peptides, and oligonucleotides
from research through to commercialization working with our partners across Operations and our internal and external manufacturing network Effectively manage performance and career development for staff and develop the next generation of leaders from within the department Directly responsible for department-wide activities (e.g., budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development) Ensures that industry standards and best practices that fit Amgen's business needs are effectively applied Represents Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally Evaluates, resolves and/or escalates issues in a timely manner Serves as a technical expert in small molecule and hybrid modalities and keeps current in drug substance development, including literature and technology development for cutting edge and regulatory driven activities Understands the technical and/or scientific capabilities of the department and provides guidance to all junior and senior staff members to resolve scientific/technical issues Conveys a broader level of understanding in pharmaceutical R&D and commercialization to the department Extensive knowledge of GLP and GMP activities Clearly understands and applies knowledge of regulatory requirements (FDA, ICH, USP, etc.) to completion of projects Leads and/or participates in technical forums for sharing of best practices and application of scientific expertise Oversees and upholds proper safety practices Provides oversight for pipeline projects through their experience and leadership in scientific, technical and regulatory issues Leads by example: Creative, hard-working, responsive, flexible, and with a demonstrated willingness to adjust in a landscape of constantly changing program outcomes and priorities Aligns project resources with program status, projected activities, and organizational prioritization. Ensures that effective teams are built and sustained within the department Facilitates cohesiveness, fosters engagement, and builds team spirit Provides feedback through coaching and effective performance appraisal and development planning Initiates and encourages scientific discourse and effective collaboration with groups outside the department Anticipates, proactively detects, and addresses problems related to departmental and inter departmental activities Communicates effectively with others, using appropriate diplomacy, sensitivity, and confidentiality where required Establishes and maintains effective communication mechanisms to keep staff appropriately informed Bridges communication between individuals, units and other organizations as necessary Informs and consults management and senior leaders appropriately What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of Scientific, Process Development and/or Technical Service experience Or Master's degree and 8 years of Scientific, Process Development and/or Technical Service experience Or Bachelor's degree and 10 years of Scientific, Process Development and/or Technical Service experience and In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: PhD with 10+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams, and successful leadership of drug substance project groups Excellent knowledge of synthetic organic chemistry, chemical process development, process characterization and validation, and technology transfer Excellent technical communication skills, both written and verbal, to interact effectively with all stakeholders Strong problem-solving skills, including application of scientific theory Strong experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/GMP, ICH) Experience in authoring briefing books, investigational new drug applications, marketing authorization applications, and responses to regulatory questions Well-recognized and established in the scientific community through a record of peer-reviewed publications and/or patents Demonstrated success developing staff, including effective feedback and coaching What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Salary Range 199,180.00 USD - 225,807.00 USD
Director, Small Molecule Process Development - Thousand Oaks, CA Let's do this. Let's change the world. In this vital role you will be part of Amgen's Process Development organization, Drug Substance Technologies
Synthetics (DSTS) plays a vital role in developing robust drug substance manufacturing processes to serve patients. Specifically, DSTS is an integrated organization of small molecule process chemists and engineers that is accountable to invent, develop, and deploy drug substance manufacturing processes and technologies to advance Amgen's synthetic and hybrid portfolio. In this role, the Director is responsible for leading a team of process chemists that drive all aspects of commercial process development, process design, process characterization, site selection for commercial manufacturing, and technology transfer for our synthetic portfolio, inclusive of hybrid modalities (e.g., peptides, oligonucleotides and bioconjugates). This is an on-site role based out of our Amgen Thousand Oaks, CA headquarters and reports to the Senior Director of Process Development. Accountable for leading a team of process chemists, ensuring that the DSTS mission and vision are implemented and upheld Accountable to advance a complex and diverse synthetics portfolio of molecules
including small molecules, bioconjugates, ADCs, peptides, and oligonucleotides
from research through to commercialization working with our partners across Operations and our internal and external manufacturing network Effectively manage performance and career development for staff and develop the next generation of leaders from within the department Directly responsible for department-wide activities (e.g., budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development) Ensures that industry standards and best practices that fit Amgen's business needs are effectively applied Represents Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally Evaluates, resolves and/or escalates issues in a timely manner Serves as a technical expert in small molecule and hybrid modalities and keeps current in drug substance development, including literature and technology development for cutting edge and regulatory driven activities Understands the technical and/or scientific capabilities of the department and provides guidance to all junior and senior staff members to resolve scientific/technical issues Conveys a broader level of understanding in pharmaceutical R&D and commercialization to the department Extensive knowledge of GLP and GMP activities Clearly understands and applies knowledge of regulatory requirements (FDA, ICH, USP, etc.) to completion of projects Leads and/or participates in technical forums for sharing of best practices and application of scientific expertise Oversees and upholds proper safety practices Provides oversight for pipeline projects through their experience and leadership in scientific, technical and regulatory issues Leads by example: Creative, hard-working, responsive, flexible, and with a demonstrated willingness to adjust in a landscape of constantly changing program outcomes and priorities Aligns project resources with program status, projected activities, and organizational prioritization. Ensures that effective teams are built and sustained within the department Facilitates cohesiveness, fosters engagement, and builds team spirit Provides feedback through coaching and effective performance appraisal and development planning Initiates and encourages scientific discourse and effective collaboration with groups outside the department Anticipates, proactively detects, and addresses problems related to departmental and inter departmental activities Communicates effectively with others, using appropriate diplomacy, sensitivity, and confidentiality where required Establishes and maintains effective communication mechanisms to keep staff appropriately informed Bridges communication between individuals, units and other organizations as necessary Informs and consults management and senior leaders appropriately What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of Scientific, Process Development and/or Technical Service experience Or Master's degree and 8 years of Scientific, Process Development and/or Technical Service experience Or Bachelor's degree and 10 years of Scientific, Process Development and/or Technical Service experience and In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: PhD with 10+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams, and successful leadership of drug substance project groups Excellent knowledge of synthetic organic chemistry, chemical process development, process characterization and validation, and technology transfer Excellent technical communication skills, both written and verbal, to interact effectively with all stakeholders Strong problem-solving skills, including application of scientific theory Strong experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/GMP, ICH) Experience in authoring briefing books, investigational new drug applications, marketing authorization applications, and responses to regulatory questions Well-recognized and established in the scientific community through a record of peer-reviewed publications and/or patents Demonstrated success developing staff, including effective feedback and coaching What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Salary Range 199,180.00 USD - 225,807.00 USD