Scientist/Senior Scientist - CHO Cell Culture & Bioprocess Development Amphastar Pharmaceuticals Inc. - 2.9 Rancho Cucamonga, CA Job Details Full-time $110,000 - $150,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Referral program Retirement plan Qualifications Biology Master's degree Full Job Description Amphastar Pharmaceuticals is seeking a highly motivated Scientist/Senior Scientist - CHO Cell Culture & Bioprocess Development to support the development and future manufacturing of biologic drug candidates utilizing CHO cell-based production technologies. The successful candidate will contribute to the development of Amphastar's biologics capabilities, with responsibility for CHO cell culture, cell-line development, upstream process development, media optimization, process characterization, and technology transfer. This position will work across research, process development, analytical development, manufacturing, quality, and regulatory functions to advance biologic candidates from early development to scalable, robust manufacturing processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following. Other duties may be assigned. Develop, optimize, and characterize CHO cell culture and upstream bioprocesses for recombinant proteins and other biologic drug candidates. Establish and optimize stable CHO cell lines , including transfection, stable pool generation, single-cell cloning, clone screening, and selection. Design and execute fed-batch cell culture studies using shake flasks and bench-scale or automated bioreactor systems. Optimize process parameters including media composition, feeding strategies, temperature shifts, pH, dissolved oxygen, agitation, seeding density, and culture duration. Develop and optimize chemically defined media and media supplements to improve cell growth, viability, productivity, process robustness, and product quality. Evaluate cellular metabolism and identify strategies to improve productivity and control undesirable metabolites. Design and execute process characterization and Design of Experiments (DOE) studies to identify critical process parameters and establish appropriate operating ranges. Analyze relationships between process conditions and critical quality attributes (CQAs) , including protein titer, charge variants, glycosylation, host-cell proteins, and other product-quality characteristics. Support scale-up and technology transfer from process development to manufacturing , including preparation of process descriptions, protocols, batch documentation, and technical reports. Support development, qualification, and implementation of CHO manufacturing processes and equipment. Troubleshoot cell culture and upstream processing issues and recommend scientifically supported corrective actions. Collaborate with downstream processing, analytical development, formulation, manufacturing, engineering, quality, and regulatory teams. Support preparation of technical documentation for regulatory submissions and responses to regulatory agencies. Maintain current knowledge of advances in CHO cell engineering, media development, bioreactor technology, continuous process improvement, and biologics manufacturing.

EDUCATION

Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Cell Biology, Molecular Biology, or a related scientific discipline; OR M.S. with significant relevant experience in mammalian cell culture and bioprocess development.

EXPERIENCE

Demonstrated hands-on experience with CHO or other mammalian cell culture systems. Experience with upstream bioprocess development, preferably involving recombinant proteins or monoclonal antibodies. Experience with fed-batch culture and bioreactor-based process development. Experience with cell-line development, clone screening, media optimization, and/or metabolic engineering strongly preferred. Experience designing controlled experiments to understand the effects of process parameters on cell growth, productivity, metabolism, and product quality. Experience with small-scale automated bioreactor systems such as AMBR 15/250 or equivalent is highly desirable. Pharmaceutical or biotechnology industry experience and familiarity with GMP biologics manufacturing are preferred.

PREFERRED TECHNICAL SKILLS

Experience in several of the following areas is highly desirable: CHO cell culture and cell-line engineering Stable cell-line development and clone selection Transient and stable transfection Fed-batch process development Chemically defined media optimization Media and feed development Mammalian cell metabolism and metabolic engineering Bioreactor operation and process monitoring AMBR or comparable automated bioreactor platforms Process characterization and DOE Scale-up and technology transfer Metabolite profiling Protein expression and titer analysis Protein A purification HPLC and product-quality analysis Charge variant and glycan analysis Host-cell protein analysis Molecular biology techniques including PCR, RT-PCR, plasmid preparation, mutagenesis, and cloning Statistical and data analysis of bioprocess experiments Desired Candidate Profile The ideal candidate combines strong scientific fundamentals with a practical understanding of how laboratory-scale CHO processes are translated into reliable manufacturing processes. We are particularly interested in individuals who can investigate relationships among cell biology, metabolism, media composition, process parameters, productivity, and product quality, and use those insights to develop robust, scalable processes. The individual should be comfortable working in a multidisciplinary environment and should be able to independently design experiments, interpret complex datasets, troubleshoot technical problems, communicate findings, and translate research results into actionable process-development strategies. Why Amphastar This position provides an opportunity to contribute to the expansion of Amphastar's biologics development and manufacturing capabilities and to help establish technologies that can support multiple future pipeline programs. The successful candidate will have the opportunity to work across the development lifecycle from cell-line and process development through scale-up, technology transfer, manufacturing, and commercialization, and play an important role in building Amphastar's internal CHO technology platform. Sunshine Act Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. EEO & Employment Eligibility Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer. Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Type:

Full-time Pay:

$110,000.00 - $150,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Vision insurance

Education:

Master's (Preferred)

Work Location:

In person