Principal Scientist, Bio Process
Principal Scientist, Bio Process
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$ 149400 - 235100
1 Vacancy
Job Description
Job Description
The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Companys biologics pipeline. We work closely with colleagues in Discovery Preclinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.
We are seeking a highly motivated and experienced individual to join our Upstream Development Department as a Principal Scientist. In this role the successful candidate will work closely with scientists in the Upstream Development Department to develop and refine technical strategy related to next generation processing for assets in early and latestage clinical development. Applicants must have effective organizational and multitasking skills demonstrated excellent scientific leadership and superior written and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong crossfunctional collaboration experience successfully mentoring junior scientist leading projects and strong external presence through scientific excellence are expected.
JOB RESPONSIBILITIES:
The successful candidate will contribute to CMC development of our Companys pipeline playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. She/He will also develop strategies for process and pipelinefacing innovation. Responsibilities include:
Leading biologic upstream process development for firstinhuman and commercial processes by efficiently developing high yield robust and scalable cell culture processes.
Providing technical direction for process development characterization commercialization and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for our company pipeline.
Advancing upstream platform process technical strategy and championing creative process improvement initiatives.
Initiating new collaborations to assess new technologies and industry strategies with relevance to our Company.
Collaborating with academia industry partners and vendors to drive development innovation and adoption of new process technologies with broad impact to projects or platform.
Keeping up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.
Mentoring and educating junior scientists.
Minimum education required:
Ph.D. with 6 years of industry experience or Master with 8 years industry experience in Chemical Engineering Bioengineering Biochemistry or a related field.
Required experience and skills:
Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
Experience in CHO fedbatch cell culture and a working understanding of downstream & analytics.
Understanding and handson experience on cell culture bioreactors including microbioreactors benchscale and pilotscale bioreactors and scaleup/tech transfer activities.
Working knowledge of cell culture media CHO cell biology and metabolism DOE statistics and computational fluid dynamics.
Ability to direct the planning execution analysis and documentation of all stages of cell culture process development.
Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors.
Knowledge of biologics CMC development cycle.
Demonstrated ability for taking initiative creativity and innovation in problem solving.
Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.
Preferred experience and skills:
Experience with stateoftheart cell culture processes including intensified inoculum and perfusion process development.
Experience with latestage commercial process development technology transfer scaledown model qualification and process characterization.
Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
Expertise in media development media/solution chemistry.
Background in data science approaches related to cell culture and predictive modeling e.g. metabolic flux analysis (MFA) omics machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).
Experience leading cross functional program development teams.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$149400.00 $235100.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
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Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
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Job Posting End Date:
06/27/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
