Current jobs related to Senior Director, Head of Process Development and Technical Services - Thousand Oaks - FUJIFILM Holdings America Corporation
-
Thousand Oaks, United States FUJIFILM Corporation Full timeOverview The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help...
-
Director Process Development
1 month ago
Thousand Oaks, California, United States Amgen Full timeUnlock Your Potential with this Unique OpportunityJoin a team that is dedicated to serving patients and making a difference in the biotechnology industry. At XYZ Company, we are committed to pushing boundaries and creating innovative solutions that impact millions of lives worldwide.Exciting Position Available: Expert in Developing BiologicsOverview:Lead a...
-
Process Development Senior Scientist
4 weeks ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Process Development Senior Scientist
4 weeks ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Process Development Senior Scientist
3 weeks ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Process Development Senior Scientist
3 weeks ago
Thousand Oaks, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...
-
Process Development Senior Scientist
3 weeks ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Process Development Senior Scientist
4 weeks ago
Thousand Oaks, United States Amgen Full timeAmgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group. Amgens DSTS group within Process Development (PD) is responsible for the invention, development, and implem Chemistry, Development, Process, Scientist, Senior, Chemist, Technology
-
Senior Associate Process Development
1 month ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Director Process Development
3 months ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Senior Associate – Process Development
1 month ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
process development Engineer
3 weeks ago
Thousand Oaks, United States Belcan Full timeprocess development Engineer Job Number: 351401 Category: Biomedical Engineering Description: Job Title: process development Engineer Location: Thousand Oaks, CA ZIP Code: 91320 Start Date: Right Away Keywords: #processdevelopmentEngineer Benefits: * Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses...
-
Director Process Development
3 months ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
-
Regional Director of Operations
7 days ago
Thousand Oaks, United States Agemark Senior Living Full timeAgemark Senior Living is Hiring! We are excited to announce an opportunity for a Regional Director of Operations in Southern California. For the sixth consecutive year, Agemark Senior Living has been recognized by Great Places to Work and FORTUNE Magazine as one of the top 20 organizations in the nation for Aging Services, ranking at #17. Position...
-
Process Development Senior Principal Scientist
2 months ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Process Development Senior Principal Scientist
1 month ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Senior Technical Business Analyst
3 months ago
Thousand Oaks, California, United States Harbinger Partners Full timeJob Title: Senior Technical Business AnalystDivision: MinnesotaRole Alignment: Business AnalysisProject ManagementStatus: Open| |Senior Technical Business AnalystThis person ensures that applications in development are system tested and partners in the creation and execution of functional test plans. This position assists with interpreting business needs...
-
Process Development Associate
2 months ago
Thousand Oaks, United States US Tech Solutions, Inc. Full timeFully onsite at Thousand Oaks, CAStandard business hours Top 3 Must Have Skill Sets: Fast LearnerTeam Player****Good Communication (must be a strong communicator please ensure this in your screening!)Must be comfortable working peak workload support, work itself is fairly routine and will be trained but needs to be picked up quickly Process...
-
Process Development Senior Associate
1 month ago
Thousand Oaks, California, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Process Development Engineer
1 month ago
Thousand Oaks, United States ACL Digital Full timeJob Title: Process Development EngineerLocation: Thousand Oaks, CA/HybridDuration: 12 MonthsDescription:ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CATop 3 Must Have Skill Sets: Purification experience, manufacturing experience, engineering experienceExperience with technical trouble shooting skillsSTRONG communication - must be comfortable speaking to a group...
Senior Director, Head of Process Development and Technical Services
1 month ago
The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki. This leadership role is responsible for the Process Development function at Fujifilm Diosynth Biotechnologies California (FDBC). FDBC provides development, manufacturing, testing, product release, and distribution of cell therapy products in partnership with our clients. The facility's on-site laboratory and production spaces are designed to support early phase clinical to commercially approved products across a range of cell types, including CAR-T and MSC's. The Process Development and Technical Services team is responsible for developing and optimizing manufacturing-ready processes for production of cell-based therapeutics, process transfer and process change implementation, and on-the-floor manufacturing technical and investigational support.
External US
Sr. Director, Head of Process Development and Technical Services
The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki.
This leadership role is responsible for the Process Development function at Fujifilm Diosynth Biotechnologies California (FDBC). FDBC provides development, manufacturing, testing, product release, and distribution of cell therapy products in partnership with our clients. The facility's on-site laboratory and production spaces are designed to support early phase clinical to commercially approved products across a range of cell types, including CAR-T and MSC's. The Process Development and Technical Services team is responsible for developing and optimizing manufacturing-ready processes for production of cell-based therapeutics, process transfer and process change implementation, and on-the-floor manufacturing technical and investigational support.
The Head of Process Development and Technical Services shall apply their demonstrated capabilities in process development across a wide range of cell types to expand the team and grow the capabilities of the FDBC Process Development, Material Science and Process Engineering functions. Prior experience in the development of new processes, process optimization and characterization, tech transfer, and commercial production support / regulatory filing is required.
The Head of Process Development and Technical Services will be a member of the Site Leadership Team that has responsibility for ensuring the site achieves its aspiration of being the Partner of Choice for companies working to advance their cell therapy products through the product development and commercialization life cycle. The Site Leadership Team works together to ensure we have the facilities and organizational capabilities to create value for our customers and their patients, our employees, and our community while delivering on the financial commitments to our stakeholders.
Reports to: FDBC Site Head
Location: Thousand Oaks, CA
Travel: Travel required (up to 20%)
Primary Responsibilities:
- Lead the Process Development team in developing manufacturing processes to deliver effective and robust production of client's cell-based therapeutics. Optimize cell culture and processing methodologies, cell selection and separation technologies, cell characterization methods, and process equipment selection meeting cGMP, Quality Systems, and regulatory requirements.
- Conduct process characterization studies to support implementation, validation, and regulatory filings.
- Identify and verify critical process parameters for new processes.
- Design, execute, and interpret experiments to demonstrate process capability.
- Utilize science-based approaches and cGMP requirements in the selection of critical raw materials and components.
- Apply technical and scientific expertise to support troubleshooting efforts and leads high-level deviation investigations for all manufacturing processes and programs.
- Drive timely decisions and facilitates active cross-functional, technical communication and information flow between team members and functions.
- Provide technical support for process related change controls and new product / process introductions (NPIs) across manufacturing network.
- Deliver documentation for technology transfer during process development phases and implementation of process changes for NPIs into manufacturing.
- Collaborates with Manufacturing and Quality teams to identify and drive process optimization initiatives and addresses opportunities for efficiency and capacity improvements in all areas of internal and external manufacturing.
- Assess suitability of technologies, equipment, and methodologies to provide a competitive advantage for our service offering and efficiency/effectiveness of client programs.
- Develops and leads the site strategy for process development and technology transfer service offering.
- Authors and/or supports IND, NDA, and other technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.
- Attract, hire, develop, and motivate scientists, engineers, and associates necessary to deliver important responsibility of the Process Development and Technical Services team.
- Manage budget and staffing requirements for the department.
Physical Demands:
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, manufacturing plant, or clinical environment.
Qualifications:
Education and Professional Requirements:
- PhD, Doctoral of Science preferred with 10+ years of relevant experience; or Master of Science 12+ years of experience; or Bachelor's degree with 15+ years of relevant experience
- Minimum 5 years of leadership or management experience.
- Demonstrated experience supporting and leading process development activities, technology transfers, cGMP manufacturing operations, and CMC regulatory submissions and inspections required.
- Depth of knowledge of cell biology, cell culture, cell processing and cell cryopreservation principles.
- Depth of knowledge with cell culture and processing technologies and analytical characterization methods.
- Broad experience working within cGMP guidelines, Quality Systems, and regulatory requirements.
- Demonstrated in-depth skills in designing, executing and interpreting experiments.
- Experience with identification, selection, and implementation of cGMP compliant raw materials and components.
- Demonstrated track record of effective leadership including the management of scientists, engineers, and associates in a clinical and commercial manufacturing setting.
- Prior CDMO experience is desirable.
- Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
- Excellent management skills: training, performance management, planning, prioritization, objective setting, meeting management, and plan execution.
- Strong communication skills (e.g., clear, and concise), team player, and proven negotiation skills.
- Good decision-making with strong judgment through collaboration and consideration of others point-of-view.
- Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
- Expert problem-solving skills.
- Ability to organize, structure and staff the organization in a changing environment.
- Strong leadership presence with ability to garner respect through sound technical analysis, business judgment and clear decision-making.
- Role model for FujiFilm and Fujifilm Diosynth Biotechnologies values and people fundamentals.
Salary and Benefits:
- $230,000 to $290,000, depending on experience
- Medical, Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
