Principal Scientist @ ArsenalBio

Principal Scientist

Analytical Development, Cell-based Assays, 23052-R-680-PS

Posted on 2/15/2023

INACTIVE

201-500 employees

Website

Programmable cell therapy company

Company Overview

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. ArsenalBio is creating products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.

Locations

Hayward, CA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Data Analysis

CategoriesNew

Biology & Biotech

Requirements

PhD (preferred), Masters or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry)
Years of relevant experience in industry as stated below:
PhD with minimum of 7 years
Masters with minimum 12+ years
Bachelors with minimum 14+ years
3+ years of hands-on analytical development experience is a must
Proficiency in multi- dimensional data analysis and interpretation using software such as Prism, R and/or JMP
Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions; previous team management experience required
Ability to lead successfully within extended project teams and handle multiple challenges under pressure
Excellent communications and presentation skills, written and verbal
Excellent organizational skills: Proactive, able to manage multiple tasks of varying complexity simultaneously

Responsibilities

Lead and supervise a cell based assay-focus team including scientists and research associates
Focus on analytical method development, assay qualification and validation, analytical strategies for multiple cell therapy programs
Serve as SME for cell-based assays and actively contribute to establish product potency and safety assays for characterization of CAR T manufacturing process and drug products
Provide analytical support for CMC and product development team for clinical-scale IND-enabling manufacturing operations, including assay qualification and assist in tech transfer in support of GMP lot release and characterization
Establish tracking and trending analysis of analytical attributes for process development runs and GMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve analytical assay performance and support process validation for Phase II clinical trial and BLA
Good understanding of cGMP environment, and Quality by Design (QBD) principles for process and assay development, qualification and validation preferred
Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges
Organize, communicate, and present complex data sets to key stakeholders and senior management
Draft SOP, technical reports and CMC sections for regulatory filing

Desired Qualifications

Successful performance track record in establishing and applying analytical assays for cell therapy products or biologics. Direct analytical development experience for clinical or commercial stage products is a plus

ArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Principal Scientist to work onsite based in our Hayward office.

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer’s inherent multi-faceted nature and overcome the challenges of addressing solid tumors with cell therapy.

Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer, and prioritize the team’s outcomes over individual goals to achieve our company mission – together.

We are seeking a talented and motivated Principal Scientist to join the ArsenalBio Technical Operations team. The individual will lead and manage an analytical cell-based assay team and work closely with team members to develop analytical test methods in support of release, characterization, and stability testing of our cell therapy products. The individual will also interact cross-functionally across the organization to enable the success of ArsenalBio.

What you will do:

Lead and supervise a cell based assay-focus team including scientists and research associates
Focus on analytical method development, assay qualification and validation, analytical strategies for multiple cell therapy programs
Serve as SME for cell-based assays and actively contribute to establish product potency and safety assays for characterization of CAR T manufacturing process and drug products
Provide analytical support for CMC and product development team for clinical-scale IND-enabling manufacturing operations, including assay qualification and assist in tech transfer in support of GMP lot release and characterization
Establish tracking and trending analysis of analytical attributes for process development runs and GMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve analytical assay performance and support process validation for Phase II clinical trial and BLA
Good understanding of cGMP environment, and Quality by Design (QBD) principles for process and assay development, qualification and validation preferred
Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges
Organize, communicate, and present complex data sets to key stakeholders and senior management
Draft SOP, technical reports and CMC sections for regulatory filing

What you will bring:

PhD (preferred), Masters or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry)
Years of relevant experience in industry as stated below:

• PhD with minimum of 7 years

• Masters with minimum 12+ years

• Bachelors with minimum 14+ years

3+ years of hands-on analytical development experience is a must
Successful performance track record in establishing and applying analytical assays for cell therapy products or biologics. Direct analytical development experience for clinical or commercial stage products is a plus
Proficiency in multi- dimensional data analysis and interpretation using software such as Prism, R and/or JMP
Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions; previous team management experience required
Ability to lead successfully within extended project teams and handle multiple challenges under pressure
Excellent communications and presentation skills, written and verbal
Excellent organizational skills: Proactive, able to manage multiple tasks of varying complexity simultaneously

What We Will Offer You:

ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.

We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.

We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $165,700–$203,000.

Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.

To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.