Senior Bioprocess Development Scientist - Protein Production

BUSINESS TITLE: Senior Bioprocess Development Scientist - Protein Production

 

WORK SCHEDULE: Onsite

 

BUDGETED SALARY: 

$120,000 - $140,000

 

Notes: 

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

• Visa sponsorship is not available for this position. All candidates must be eligible to work and live in the U.S.

 

SCHOOL/UNIT DESCRIPTION:

Sarafan ChEM-H is an interdisciplinary institute focused on connecting Chemistry, Engineering, and Medicine for Human 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

Responsibilities

Core Duties:

• Lead development activities for new processes and procedures forfirst-in human clinical materials development including design ofprocess scale-up and scale-out, closed systems and engineering runs tomeet clinical materials requirements.

• Lead clinical materials manufacturing campaigns; responsible foroversight and coordination of junior staff in conducting all activitiesrelated to manufacturing; lead decision-making when collaborating withfunctional teams: operations, regulatory affairs, quality systems,business & administration; maintain regular reporting to functionalmanager.

• Develop methods for, perform and supervise manufacturing ofclinical materials according to cGMP standards in Biosafety Level 2(BSL2), cGMP-level work conditions and adherence to correspondingrequirements.

• Develop standard operating procedures (SOPs), Batch Records andproduct specifications. Critically assess experimental data, provideinterpretation of results, and ensure data quality and integrity.Present data to functional manager and collaborative groups to supportproduct and process specification.

• Author or co-author of manuscripts for publication inpeer-reviewed journals. Remain current on literature and standardindustry practices by attending scientificmeetings/conferences.

• Provide support for regulatory filings including draftingChemistry, Manufacturing and Controls (CMC) section of InvestigationalNew Drug (IND) Regulatory Filing.

• May manage two or more staff in day-to-day operations forfunctional area(s) of responsibility. Responsible for hiring andretaining staff, career coaching, personal development for directreports and accountable for the performance of employees. Ensure workcompletion within schedules and constraints.

• May serve as a liaison to senior management, cross-functionalareas, schools and external organizations such as sponsors andgovernment agencies.

• May serve as safety officer; responsible for ensuringimplementation of EH&S, fire and city regulations for laboratorysafety.

Minimum Education andExperience

Bachelor's degree in related scientific field and four years ofrelated experience, or Master’s degree and two years of relatedexperience or an equivalent combination of education and relevant workexperience.

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 mastercomputer programs, databases and scientific applications

• Ability to work independently, maintain relationships and provideongoing reporting to functional management

• Excellent organizational skills and demonstrated ability tocomplete detailed work.