Scientist II/Senior Scientist, Downstream Process Development

Posted 2 Days Ago
Be an Early Applicant
South San Francisco, CA
Senior level
Healthtech • Biotech
The Role
The Scientist II/Senior Scientist will oversee downstream AAV purification processes, lead optimization studies, and develop large-scale purification strategies. Responsibilities include mentoring junior staff, managing GMP manufacturing support, and ensuring compliance with regulatory standards.
Summary Generated by Built In

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. 

We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

Position Summary:

The Scientist II/ Sr. Scientist for Downstream Process Development will oversee all technical aspects of downstream AAV purification both internally and at CDMOs. This position will be responsible for implementing large scale AAV purification (50L+) and conducting routine purification and optimization studies. This position will also be responsible for growing the team and providing mentorship to junior associates. The ideal candidate will lead with a strong sense of downstream PD ownership, strategic and creative thinking, and the drive to identify problems and develop effective and practical solutions while ensuring standards are achieved through continuous process improvements.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

  • BS+8 / MS+6 / PhD+2 years minimum industry experience in a process development or MSAT role
  • Prior experience developing purification processes for virus, VLP, or gene therapy vectors for GMP clinical manufacturing.
  • Experience with single-stranded and self-complementary AAV chromatography-based downstream processes
  • Experience with CsCl Ultracentrifugation AAV purification processes
  • Experience running Refyn, alkaline gel, CE-SDS, SEC-HPLC, and other similar analytical assays
  • Experience with process characterization including viral clearance studies.
  • Familiarity with regulatory standards for investigational therapeutics (biologics or gene therapy), which may include contributions to IND or CTA filings.
  • Skilled in statistical analysis and DoE methodologies, and familiarity with JMP, MiniTab, or DesignExpert software.

Responsibilities:

This position requires ambition, adaptability, and a team-oriented mindset, but also a strong ability to organize parallel projects and work independently to develop a strong downstream process development infrastructure.

  • The successful candidate will lead downstream process development for AAVs and support process optimization at CDMOs
  • Develop, operate and optimize processes for large scale purification of AAVs, not limited to tangential flow filtration, anion exchange chromatography, affinity chromatography etc.
  • Support GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, and lead risk assessment
  • Lead internal studies to develop process flows to generate product for various non-clinical programs.
  • Write, revise, review and/or approve SOPs, controlled forms, and related documents to ensure best practices and current operations.
  • Collaborate cross-functionally with upstream process development (both internal and at CDMO), analytical development and other functions.
  • Lead and train junior associates within the downstream process development function.
  • Stay attuned to latest AAV purification technologies and contribute to continuous process development/optimization strategies.


Compensation: The salary range for this position is $120,000 to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.



Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Top Skills

Aav
The Company
South San Francisco, CA
41 Employees
On-site Workplace
Year Founded: 2018

What We Do

Epicrispr Biotechnologies is a biotechnology company developing ultracompact therapies to modulate gene expression in vivo using the smallest known Cas protein, CasMINI

Similar Jobs

South San Francisco, CA, USA
36 Employees
120K-160K Annually

Collectors Logo Collectors

Software Engineer, Back-end (Collectors Experiences)

Consumer Web • eCommerce • Machine Learning • Professional Services • Software • Sports • Analytics
Santa Ana, CA, USA
1100 Employees

Celonis Logo Celonis

Senior Software Engineer - Developer Tools

Big Data • Productivity • Software • Database • Analytics • Business Intelligence • Consulting
Los Angeles, CA, USA
3000 Employees
165K-205K Annually

ServiceNow Logo ServiceNow

Staff Software Engineer

Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
San Diego, CA, USA
26000 Employees
143K-250K Annually

Similar Companies Hiring

Sage Thumbnail
Software • Healthtech • Hardware • Analytics
New York, NY
44 Employees
Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account