SUMMARY/JOB PURPOSE:

The Bioconjugation Process Development Director is responsible for the process development and manufacturing of large molecule bioconjugates for biotherapeutics, with a focus on Antibody Drug Conjugates (ADCs). The successful candidate will drive the CMC elements related to bioconjugation throughout the product life cycle. The role requires technical expertise in conjugation chemistry, reaction processes and purification process development. A familiarity with critically relevant areas such as analytical characterization, formulation, and the general CMC scope for biologics is also required. In addition, the role requires a successful track record of carrying out development and manufacturing activities, including a demonstrated ability to work effectively with CDMOs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Subject Matter Expert in bioconjugation (ADC) process development and manufacturing in support of CMC activities.

• Work closely with research function to understand relevant conjugation chemistries and transition bioconjugation process from research to CMC development.

• Develop, plan and lead process development and manufacturing of bioconjugation process and associated CMC requirements.

• Oversee development and technical transfer of processes between Third Parties (CDMOs and Partners).

• Lead and manage CDMOs on behalf of Exelixis in the areas of bioconjugation development and manufacturing, including alignment and oversight on planning and budgetary activities.

• Partner with Exelixis CMC and Quality colleagues, and CDMOs, to support cGMP manufacturing within the Exelixis-CDMO quality systems.

• Lead efforts to identify and champion new chemistries and process technologies for bioconjugation.

• Work collaboratively with SMEs in other CMC areas such as formulation and analytical to develop sound, integrated plans for development and manufacturing of ADCs.

• 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:

• Supervises staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, etc.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and a minimum of thirteen (13) years related experience.

• MS/MA in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and a minimum of eleven (11) years related experience.

• PhD in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and a minimum of eight (8) years related experience.

• Experience/The Ideal for Successful Entry into Job:

• Direct experience designing and implementing experiments to evaluate bioconjugation processes, including ADCs.

• Experience with ADC chemistry, reaction processes and purification methods. Strong development experience 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 (bioconjugations).

• 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 mAbs, bispecifics and/or linker-toxins used in ADC production, is a plus.

• Experience in biologics related CMC regulatory activities and in the support of manufacturing quality for biologics molecules

Knowledge/Skills:

• Ability to multitask, work collaboratively across a matrix organization and ensure flexibility in adynamic 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 bioconjugation process development and manufacturing.

• Knowledge of cGMPs, regulatory guidelines, and relevant qualification and validation practices.

• Excellent writing, presentation, and oral communication skills

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work

• Travel required - up to 20 % of time traveling

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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.