Senior Bioprocess Development Scientist

• Protein Production Stanford University
• 4.2 Stanford, CA Job Details Full-time $120,000
• $140,000 a year 1 day ago Qualifications Data integrity assurance Biology FDA submissions Biological safety protocols Data quality checks Advanced cell culture techniques Stability testing Record keeping Computer operation Manufacturing management Staff supervision Immunological assays Molecular Biology Biochemistry Laboratory safety EHS Fire safety Microbiological culture handling Data analysis reporting Stability studies in drug product development Document control experience within pharmaceutical industry Managing laboratory operations teams Immunological laboratory techniques Safety regulations Operations coordination Coaching Protein analysis (analytical chemistry specialty) Publishing papers in peer-reviewed journals Collaborating with government agencies Corrective and preventive actions (CAPA) Full Job Description

BUSINESS TITLE

: Senior Bioprocess Development Scientist

• Protein Production

WORK SCHEDULE

Onsite

BUDGETED SALARY

$120,000

• $140,000 This is initially an 18-month fixed term role with the possibility of extension based on performance and budgetary considerations.

SCHOOL/UNIT DESCRIPTION

Sarafan ChEM-H is an interdisciplinary institute focused on connecting Ch emistry, E ngineering, and M edicine for H uman Health. The institute was founded as a joint venture of the Schools of Medicine, Engineering, and Humanities and Sciences. The proximity of world-class biologists, chemists, engineers, and clinicians at Stanford presents a unique opportunity to study human biology at a molecular level, to translate this knowledge into groundbreaking products and services that promote healthy living, and to educate a new cadre of "physician-scientist-engineers" who will lead a rapidly evolving industry. The institute's Nucleus serves as shared laboratories where trainees from diverse disciplines in science, engineering and medicine pursue projects under the mentorship of the center's Directors, thereby gaining hands-on skills in high-throughput screening, medicinal chemistry, metabolomics, protein chemistry, and structural biology.

POSITION SUMMARY

The Microbiome Therapies Initiative (MITI) at Sarafan ChEM-H is seeking a highly motivated protein scientist for a role in our ambitious new effort to develop and produce commensal vaccines in-house at Stanford for clinical use. At MITI, we aim to take advantage of the tremendous promise of the microbiome to treat human disease. In this position, you will be MITI's primary expert on protein expression and purification, reporting to the Associate Director/GMP Supervisor. You will lead the development, execution, and troubleshooting of an array of protein production strategies needed to support the success of the commensal vaccine platform. You will adapt these strategies for the GMP production of MITI's clinical products, participating in the redesign of our GMP suite for vaccine production and in the in-house manufacturing, formulation, and release process itself. Your colleagues will be MITI's GMP manufacturing, quality, and regulatory team members. You will collaborate with members of the Fischbach lab at Stanford who have created this novel vaccination strategy. Ideal candidates are self-starters, comfortable with autonomy, yet embrace opportunities to tackle new problems and challenges as part of a dynamic team in a start-up-like environment within the University.

Key responsibilities will include:

Design, coordinate, execute, and troubleshoot protein expression and production processes across multiple projects Work with the Associate Director to scale/adapt existing production processes for in-house GMP production Perform GMP pilot and production runs as part of MITI's manufacturing team Author relevant SOPs, work instructions, and batch records, and participate in GMP trainings, document control, and CAPA processes Contribute to CMC sections of Investigational New Drug (IND) applications

PREFERRED/DESIRED QUALIFICATIONS

PhD in Biochemistry, Cell Biology, Molecular Biology, or a related field with 2+ years of relevant industry experience Expertise in recombinant protein expression using bacterial and mammalian expression systems Experience troubleshooting yield and stability problems using construct design and expression protocol adjustment Expertise in recombinant protein purification, process workflow design, and downstream equipment operation Proficient in comprehensive protein characterization, including purity and identity (SDS-PAGE), biophysical stability, and contaminant analysis (endotoxin) Experience with in-process testing methods such as flow cytometry and ELISA Experience working in a cGMP environment Excellent communication and organizational skills

Core Duties :

Lead development activities for new processes and procedures for first-in human clinical materials development including design of process scale-up and scale-out, closed systems and engineering runs to meet clinical materials requirements. Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager. Develop methods for, perform and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2), cGMP-level work conditions and adherence to corresponding requirements. Develop standard operating procedures (SOPs), Batch Records and product specifications. Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity. Present data to functional manager and collaborative groups to support product and process specification. Author or co-author of manuscripts for publication in peer-reviewed journals. Remain current on literature and standard industry practices by attending scientific meetings/conferences. Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing. May manage two or more staff in day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees. Ensure work completion within schedules and constraints. May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies. May serve as safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety. Minimum Education and Experience Bachelor's degree in related scientific field and four years of related experience, or Master's degree and two years of related experience or an equivalent combination of education and relevant work experience.

Knowledge, Skills and Abilities :

Excellent understanding of scientific principles Working experience with aseptic cell culture cGMP clean room experience Excellent computer skills and ability to learn quickly and master computer programs, databases and scientific applications Ability to work independently, maintain relationships and provide ongoing reporting to functional management Excellent organizational skills and demonstrated ability to complete detailed work.