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Manage the Chemistry Manufacturing and Control (CMC) activities related to Dynavax’s oligonucleotide development programs. Work with Dynavax internal teams and contract manufacturing organizations (CMOs) to manage and execute strategies for Phase 1 through Phase 3 clinical development of lead molecules. Manage and author appropriate development reports for support of regulatory filings. Other areas of responsibilities include but not limited to oligonucleotide manufacturing and support of early development supply of oligonucleotides.
• Works closely with the appropriate project team(s) as the Global Technologies Operation’s representative for oligonucleotide development to ensure effective operational execution.
• Manage the CMC aspects of oligonucleotide development (process development, manufacturing, QC etc).
• Manage external manufacturer relations and deliverables to ensure timely and effective delivery based on project deliverables.
• Develop tactical methods to overcome real-time manufacturing issues.
• Responsible for supporting new oligonucleotide development through external vendors.
• This position may travel up to 10%.
• Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Other duties as assigned.
KNOWLEDGE AND SKILL REQUIREMENTS:
• BS/MS in Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutics, or closely related discipline and 5+ years’ relevant industry experience.
• At least 2 years experience in a pharmaceutical CMC/GMP environment.
• Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC.
• Exceptional written and verbal communication skills.
• Proven ability to implement against strategic plans.
• Project management and team leadership experience is required.
• Demonstrated competencies in a core CMC discipline such as formulations, manufacturing, and/or chemical synthesis.
• Demonstrated ability in synthesizing information to make critical decisions in a timely manner.
• Exceptional interpersonal skills with proven ability to build positive work relationships across functional lines and must possess the ability to motivate employees.
• Must possess the ability to effectively manage multiple projects.
• Proven problem-solving skills are a must.
• Personal attributes include:
• Flexibility and integrity,
• Goal oriented and self-starter,
• Practical approach to science and business,
• Demonstrated good judgment and decision-making experience,
• Collaborative and team oriented.
• Excellent communication and interpersonal skills.
• Proven leadership ability and problem-solving skills are a must.
This level manager receives assignments in the form of objectives and establishes goals to meet objectives. Incumbent manager provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect subordinate organizations.
This position works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors and exercises judgment within generally define practices and policies in selecting methods and techniques for obtaining solutions/results. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.