Exelixis
Biologics Upstream Process Director
Exelixis, Alameda, California, United States, 94501
SUMMARY/JOB PURPOSE:The Biologics Upstream Process Director leads the technical aspects of process development and manufacturing for antibodies and novel recombinant proteins. The role requires a strong background in the process technology and manufacturing of recombinant proteins, in the areas of cell line development, cell culture process optimization & development, media development, scale-up and technology transfer. The Director has experience in driving CMC aspects of upstream cell culture process development and manufacturing for therapeutic proteins for post-IND phase. This includes a strong track record of development and driving post-IND process development, process characterization and technical transfer activities for recombinant proteins to establish robust GMP processes. S/he also has experience authoring IND and regulatory documents for antibody intermediates and novel recombinant proteins.Essential Duties And Responsibilities:Subject Matter Expert in recombinant protein process technology in support of CMC. Deep expertise in cell culture processes for antibodies and novel proteins is required.
Work closely with Exelixis Biotherapeutics Discovery to translate and transition new technology and programs to development, including developability assessments and the generation of a technical transfer package to initiate post-IND CMC development work.
Develop plan and lead process development, optimization and scale-up, process characterization of cell culture process and manage associated CMC requirements across the product lifecycle.
Work with CDMOs on behalf of Exelixis in the areas of process development and optimization, and technical transfer and trouble shooting.
Lead efforts to identify and champion new process technologies for cell culture processes.
Work collaboratively with SMEs in other CMC areas, such as purification, formulation and analytical, to develop and execute robust, integrated plans for stability, development, and manufacturing.
Drive process risk assessments, process characterization, control strategy and validation for post-IND programs.
Manage technical aspects of critical incoming materials and commodities for protein processing, including cell culture media, filtration devices and other disposable equipment.
Remain current on Health Authority guidance and expectations and contribute to regulatory strategy and submissions.
Help develop protein process laboratory capabilities within Exelixis to align with external CDMOs and enable the growth of the Biologics portfolio.
Supervisory Responsibilities:
Provide direction to other individuals.
May supervise staff of 1 or 2, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:BS/BA in biochemistry/chemistry, biological sciences, pharmaceutical sciences, chemical engineering, or related degree and a minimum of thirteen years related experience; or,
MS/MA in analytical chemistry/biochemistry/chemistry, biological sciences, pharmaceutical sciences, chemical engineering, or related degree and a minimum of eleven years related experience; or,
PhD in analytical chemistry/biochemistry/chemistry, biological sciences, pharmaceutical sciences, chemical engineering, or related degree and a minimum of eight years related experience; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:Experience and subject matter expert in recombinant protein process technology related to Biologics CMC.
Deep expertise in Cell Culture for Biologics CMC.
Experience establishing, developing, transferring, optimizing, scaling-up, and qualifying/validating cell culture processes for biopharmaceutical products.
Experience with Regulatory requirements for process development and manufacturing across the product lifecycle.
Experience managing internal lab capabilities for protein generation and process development.
Experience bringing biologics from post-IND through licensure.
Experience with critical regulatory activities for biologics such as process risk assessments, process characterization and validation, and control strategy.
Experience with documentation of experiments, analyzing data, generating high-quality technical reports, and Quality/Regulatory information.
Experience with Project Management (budgeting, timelines, resourcing, planning) to oversee development activities and integrate into broader project plan.
Knowledge/Skills:Ability to multitask, work collaboratively across a matrix organization and ensure flexibility in a dynamic corporate and team environment.
Thorough 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 leadership 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 make necessary adjustments.
Thorough technical knowledge of analytical characterization for biological molecules.
General knowledge of cGMPs, regulatory guidelines, validation practices and other relevant regulatory requirements.
Excellent writing, presentation, and oral communication skills.
JOB COMPLEXITY:Working Conditions:Environment: primarily working indoors, performing clerical work.
Travel required - 20% of time.
DISCLAIMERThe 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.
#J-18808-Ljbffr
Work closely with Exelixis Biotherapeutics Discovery to translate and transition new technology and programs to development, including developability assessments and the generation of a technical transfer package to initiate post-IND CMC development work.
Develop plan and lead process development, optimization and scale-up, process characterization of cell culture process and manage associated CMC requirements across the product lifecycle.
Work with CDMOs on behalf of Exelixis in the areas of process development and optimization, and technical transfer and trouble shooting.
Lead efforts to identify and champion new process technologies for cell culture processes.
Work collaboratively with SMEs in other CMC areas, such as purification, formulation and analytical, to develop and execute robust, integrated plans for stability, development, and manufacturing.
Drive process risk assessments, process characterization, control strategy and validation for post-IND programs.
Manage technical aspects of critical incoming materials and commodities for protein processing, including cell culture media, filtration devices and other disposable equipment.
Remain current on Health Authority guidance and expectations and contribute to regulatory strategy and submissions.
Help develop protein process laboratory capabilities within Exelixis to align with external CDMOs and enable the growth of the Biologics portfolio.
Supervisory Responsibilities:
Provide direction to other individuals.
May supervise staff of 1 or 2, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:BS/BA in biochemistry/chemistry, biological sciences, pharmaceutical sciences, chemical engineering, or related degree and a minimum of thirteen years related experience; or,
MS/MA in analytical chemistry/biochemistry/chemistry, biological sciences, pharmaceutical sciences, chemical engineering, or related degree and a minimum of eleven years related experience; or,
PhD in analytical chemistry/biochemistry/chemistry, biological sciences, pharmaceutical sciences, chemical engineering, or related degree and a minimum of eight years related experience; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:Experience and subject matter expert in recombinant protein process technology related to Biologics CMC.
Deep expertise in Cell Culture for Biologics CMC.
Experience establishing, developing, transferring, optimizing, scaling-up, and qualifying/validating cell culture processes for biopharmaceutical products.
Experience with Regulatory requirements for process development and manufacturing across the product lifecycle.
Experience managing internal lab capabilities for protein generation and process development.
Experience bringing biologics from post-IND through licensure.
Experience with critical regulatory activities for biologics such as process risk assessments, process characterization and validation, and control strategy.
Experience with documentation of experiments, analyzing data, generating high-quality technical reports, and Quality/Regulatory information.
Experience with Project Management (budgeting, timelines, resourcing, planning) to oversee development activities and integrate into broader project plan.
Knowledge/Skills:Ability to multitask, work collaboratively across a matrix organization and ensure flexibility in a dynamic corporate and team environment.
Thorough 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 leadership 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 make necessary adjustments.
Thorough technical knowledge of analytical characterization for biological molecules.
General knowledge of cGMPs, regulatory guidelines, validation practices and other relevant regulatory requirements.
Excellent writing, presentation, and oral communication skills.
JOB COMPLEXITY:Working Conditions:Environment: primarily working indoors, performing clerical work.
Travel required - 20% of time.
DISCLAIMERThe 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.
#J-18808-Ljbffr