Senior Process Development Associate

Location
South San Francisco, CA, United States
Posted
Feb 17, 2021
Ref
1748236333
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Integral Medicines uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options

Summary: In collaboration with the Associate Director for Process Development, this role will be responsible for all aspects of the development, manufacturing, testing, and release of drug substance and drug product beginning at the pre-clinical stage and continuing through commercial launch. The Process Development and Manufacturing Associate will collaborate on the process design, development of strategic direction and support for all technical operations programs and processes.

What You Will Do:
    • Provide operational support for the development of processes for complex cell and gene therapies using gene-editing methods like CRISPR/Cas9
    • Manufacture clinical products at contracted CDMOs or in-house
    • Support the continued development of robust, cost-effective, scalable cell manufacturing processes for Graphite Bio's severe rare genetic disease and oncology pipeline
    • Perform hands-on work in the cell culture lab and provide training on GMP cell and gene therapy manufacturing
    • Work cross-functionally with the process development, analytical development, translational development, and clinical development teams to execute on corporate goals
    • Write and review technical documents including SOPs, batch records, test procedures, work instructions, and summary reports
    • Perform analytical testing using methods like flow cytometry, ddPCR and CFU assays during development and scale-up runs
    • Identify and evaluate outsourced CMOs/CROs and vendors to determine that they have the required scientific and technical expertise, equipment and facility capabilities, and quality/compliance standards to conduct CMC related activities
    • Assist with the integrated process to transfer technology from the research and development programs to the clinical manufacturing facility. This includes performing the clinical production activities for the Sickle-cell disease program and maintaining training on site-specific SOPs and procedures
    • Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings
    • Coordinate with vendors as needed and manage inventory
    • As required, design and monitor studies performed by selectedoutsourced vendors. Perform data analysis and prepare or review the final report(s) for all such studies to ensure scientific integrity and compliance with regulatory requirements.
    • Collaborate with Quality Assurance in conducting vendor compliance audits and preparing audit reports.what You


What You Will Bring:
    • Bachelor's Degree in biology, pharmaceutical sciences, biotechnology or related field
    • 3+ years' experience in a related position in a pharmaceutical or Biotech Company
    • Experience with CliniMACS Prodigy cell isolations and closed system manufacturing preferred
    • Experience with process development and manufacturing relevant to cell and gene therapies preferred
    • Experience with flow cytometry and PCR based assays preferred:
    • Experience with aseptic cell culture in a cGMP environment
    • Excellent teamwork and collaboration skills.
    • Outstanding written and verbal communication skills.
    • Understanding of FDA guidelines and GMP regulations.
    • Ability to organize and multi-task as needed in a start-up environment.


Fit with Graphite Bio's culture:

Ability to build strong relationships with co-workers of various backgrounds and expertise

Ability to function at a high level in a team setting whether leading the group or acting as an individual

contributor

Values-based leadership consistent with Graphite Bios' Core Values

Excitement about the vision and mission of Graphite Bio

Flexibility

Integrity

Compensation/ Benefits:

Competitive salary with equity

Free on-site gym access

Free on-site meals and coffee bar

Health benefits

Graphite Bio is an equal opportunity employer, and all qualified applicants will receive consideration for

employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national

origin, protected veteran status, or disability status, or any other characteristic protected by law.