Director – Small Molecule Process Development

Director – Small Molecule Process Development

Requirements

• Doctorate degree and 4 years of Scientific, Process Development and/or Technical Service experience
• Master’s degree and 8 years of Scientific, Process Development and/or Technical Service experience
• Bachelor’s degree and 10 years of Scientific, Process Development and/or Technical Service experience
• At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Responsibilities

• 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

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