Director, External Manufacturing Operations

Job Description
Overview:

The incumbent in this position is expected to partner with other members of the Global Technical Operations’ (GTO) team to ensure product and/or program expectations are applied at the CMO.

A director level position may participate in the development of corporate and/or organizational policies which may include the authorization to implement such policies. This position level provides general direction to and review of manager level personnel in various functional areas and/or teams.
Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Works on abstract problems across functional areas of the business; identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Erroneous decisions may have a serious impact on the overall success at the functional and/or program level.

Responsibilities:

Primary liaison for day-to-day decision making and/or evaluation/resolution of issues between Dynavax and the CMOs.

Oversee and provide guidance to CMOs to ensure quality of production.

Act as an internal project leader, coordinating both internal and external stability, process, formulation, quality and manufacturing resources.

Manage CMO activities to contract.

Accountable for CMO performance for delivering quality product on-time and per budget.

Assist with negotiation of contracts and agreements, including development performance indicators and compliance requirements.

Provide management with timely, reliable and structured reports regarding CMO performance, variance analysis and contingency plans for corrective measures.

May participate in the sales operations planning and implement appropriate initiatives to align CMO deliverables with sales planning requirements.

This position requires travel up to 25%.

Other duties as assigned.

Qualifications:

PhD or MS in Chemical or Biochemical science with 10+ years relevant work experience including 5 years management experience in a CMC discipline such as Process Development, Formulations, etc.

Knowledge of and leadership experience with manufacturing of pharmaceutical products.

Knowledge and experience of cost of goods management and corresponding financial impact of business decisions.

Global operations experience including import/export operations, working knowledge of regulatory, drug licensing and manufacturing operations requirements.
Proven success in leading multidisciplinary project teams with excellent communication, problem-solving, and critical-thinking skills.
Demonstrated experience in establishing and maintaining supplier/contractor relationships.

Working knowledge of international GMP requirements and quality systems.

Proven successful leader in building positive relationships across functional lines; able to influence positive decisions and build consensus in project meetings, external associates, and with senior management.

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.

Company

Dynavax Technologies

Job Code

State or Province

California

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