Senior Director, Biologics Process

Job Description

The Senior Biologics Process Director is responsible for the process development and manufacturing of recombinant proteins (monoclonal antibodies, fusion proteins and bi-specific constructs) to drive the related CMC elements throughout the product life cycle of large molecule biotherapeutics. The role requires a strong technical background in biologics processing, primarily in the areas of cell culture and purification, as well as familiarity with critically relevant areas such as analytical characterization, formulation, and cell line. In addition, the role requires a successful track record of carrying out development and manufacturing activities virtually, including a demonstrated ability to work effectively with CDMOs.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Subject Matter Expert in recombinant protein process development and manufacturing in support of CMC Develop plan and lead process development and manufacturing of biological molecular entities and associated CMC requirements Lead and manage CDMOs on behalf of Exelixis in the areas of biologics manufacturing and process transfer, including alignment and oversight on planning and budgetary activities Oversee development and technical transfer of processes between Third Parties (e.g. CMOS and Partners) Partner with Exelixis CMC and Quality Control colleagues, and CDMOs, to support cGMP manufacturing within the Exelixis-CDMO quality system Lead efforts to identify and champion new process technologies for biologics process and manufacturing Provide leadership and direction broadly across CMC Biologics to drive the expanding pipeline and to establish a high-functioning Biologics team within Exelixis Work collaboratively with SMEs in other CMC areas such as formulation and analytical to develop sound, integrated plans for development and manufacturing Define and manage technical projects across Exelixis and CDMOs with focus and urgency Remain current on Health Authority guidance and expectations, and contribute to regulatory strategy and submissions

SUPERVISORY RESPONSIBILITIES: Directly supervises employee(s) Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors

EDUCATION/EXPERIENCE/SKILLS: Education: BS/BA in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and fifteen years related experience MS/MA in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and thirteen years related experience PhD in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and eleven years related experience Equivalent combination of education and experience

Experience: Direct experience designing and implementing experiments to evaluate recombinant protein processes (antibodies, bispecifics, fusion proteins) Experience with mammalian cell-based processes is required. Additional experience with bacterial based processes strongly preferred Experience developing and optimizing both upstream and downstream processes, and overseeing internal/external technical transfers Strong development experiences bringing biologics from Phase I through commercial, including experience in late stage activities such as CMC risk assessments, process characterization and validation. Demonstrated experience working with Contract Development Manufacturing Organizations (CDMOs) in North America, EU and Asia Demonstrated experience and working knowledge of technical transfer for Biologics manufacturing (cell line, upstream, downstream) Experience with documentation of experiments, analyzing data, generating high-quality technical reports, and Quality/Regulatory information Experience with Project Management (budgeting, timelines, resourcing, planning) Additional experience with the development and manufacturing of Bioconjugates such as Antibody Drug Conjugates is a plus. Experience in biologics related CMC regulatory activities and in the support of manufacturing quality for biologics molecules is required.

Knowledge/Skills/Abilities: Ability to multitask, work collaboratively across a matrix organization and ensure flexibility in a dynamic corporate and team environment Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management Excellent judgement and problem-solving skills, including negotiation and conflict resolution Strong scientific, management and communication skills Ability to leverage both internal and external resources to expedite and deliver projects Ability to work in a team environment, create timelines and continually to make necessary adjustments Strong attention to details, while also able to see and align with the big picture Technical knowledge in Biologics process development and manufacturing Knowledge of cGMPs, regulatory guidelines, validation practices and other relevant regulatory requirements Excellent writing, presentation, and oral communication skills

JOB COMPLEXITY: Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results Uses professional concepts to solve complex problems in creative and effective ways and contribute to the advancement of Exelixis company objectives

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.