Senior Scientist/Principal Scientist, Analytical Sciences & Operations

Stealth Mode Biotechnology Company; Philadelphia (Philadelphia County); On-site; USD 80,000 - 150,000; Full time

Job summary

Join a pioneering biotechnology startup dedicated to revolutionizing cancer treatment. As a Senior Scientist/Principal Scientist, you will play a crucial role in developing analytical capabilities and operations for innovative cell therapies. Your expertise will guide the establishment of systems and processes that ensure quality and compliance in our product development efforts. Collaborate with a passionate team committed to scientific rigor and impactful solutions, while contributing to a culture that values collaboration and feedback. This is an exciting opportunity to make a difference in the lives of cancer patients through groundbreaking research and development.

Benefits

Competitive compensation package

Equity ownership

401(k) with generous contribution

Life insurance

Flexible PTO policy

Substantial additional benefits

Qualifications

• 5+ years in analytical development or 8+ years with a Master's degree.
• Expertise in analytical platforms for gene and cell therapy products.

Responsibilities

• Lead analytical CDMO/CTO network for product supply.
• Manage external testing logistics and operations.

Skills

Analytical Development

Quality Control

GMP Compliance

Root Cause Analysis

Communication Skills

Project Management

Time Management

Education

Ph.D. in Immunology or related field

Master's Degree in relevant discipline

Tools

Bio-analytical Methods

Bio-physical Methods

Bioassay-based Methods

Job description

Senior Scientist/Principal Scientist, Analytical Sciences & Operations

Philadelphia, Pennsylvania, United States

About Us:

We are a startup biotechnology company dedicated to the development of novel cell therapies to cure cancers. The company was founded on pioneering work carried out in the laboratories of Dr. Carl June and Dr. Andy Minn (University of Pennsylvania), Dr. Kole Roybal (UCSF), and Dr. Christopher Garcia (Stanford University). We are using viral vectors, universal targets, and novel cytokine biology to enhance CAR T activity in solid tumors. Our therapeutic approach has potential to be used across multiple tumor types, enabling us to treat significant numbers of cancer patients.

At our company, you would become one of our early team members where you would help to engineer a universal treatment across solid tumors, be a vital part of building our culture, and help create a world where all cancer patients can be cured. We are determined to deliver with urgency to discover new solutions and we always stay dedicated to scientific rigor; we have an ownership mindset because each and every one of us is integral to our success. Collaboration is core for us because we believe that by bringing people together with diverse perspectives, we make a stronger whole. And, we show we care about our work and each other by sharing feedback - ultimately in service of our vision to empower people to continue forward with their lives – cancer free.

The Role:

Reporting to the Head of Analytical & Product Sciences, the Senior Scientist/Principal Scientist will lead our efforts in establishing capabilities, systems, and processes related to Analytical Sciences and Operations (AS& O) in support of development of the company’s analytical platform as a key element of our CMC and GMP supply strategy. The AS& O function will play a key role leading our technical interface with external partner contract development/manufacturing and contract testing organizations (CDMOs/CTOs) in both a developmental and operational capacity. Developmental responsibilities include facilitating the late-stage development of QC track methods, enabling analytical technology transfer activities, driving the planning, execution and reporting of phase-appropriate method validation and leading the planning, execution, and reporting of longitudinal stability studies in support of product expiry. Operationally, the Senior Scientist/Principal Scientist will act as the primary point-of-contact for CDMOs/CTOs partners and lead all aspects of operational and logistical planning for release and stability testing, and external investigational testing as needed. This individual will act as the primary technical subject matter expert supporting all external deviations, investigations, and work collaboratively with the external partners and internal subject matter experts on root cause determination and CAPA development, implementation, and effectiveness assessment in line with GXP principles. Additionally, the Scientist will provide coordination support for internal routine non-regulated analytical testing in collaboration with stakeholders across the company.

Key Responsibilities:

• Act as the primary interface for analytical CDMO/CTO network, supporting developmental & GMP supply of the company’s product portfolio (Oncolytic Adenovirus, CAR T)
• Provide guidance on definitive method development activities supporting method lock of QC-track assays
• Facilitate analytical technology transfer and phase-appropriate validation of test methods at external vendors and support method performance and lifecycle via performance monitoring
• Lead all aspects of external testing logistics and operations including sample management, critical reagent management, and scheduling
• Manage GMP and developmental batch data and batch analysis; generate testing certificates and certificates of analysis
• Manage all aspects of external quality systems including change control, deviations/investigation, CAPA development/implementation and effectiveness checks
• Lead planning, execution, and reporting of longitudinal stability studies in support of product expiry
• Coordinate internal analytical testing support and routine testing
• Interface with internal and external Quality Assurance partners and partner with stakeholders to contribute to building out internal Quality systems in support of analytical operations

Required Experience & Skills:

• Ph.D. in relevant discipline (Immunology, Cell Biology, Molecular Biology, Biochemistry, etc.) with at least 5 years of experience or Master’s Degree/equivalent with at least 8 years working in analytical development, analytical operations, and/or Quality Control in the cell and gene therapy drug development space
• Demonstrated technical and scientific competency across an array of analytical platforms including bio-analytical, bio-physical, and bioassay-based analytical methods for analytical testing of gene and cell therapy-based products, intermediates, and raw materials including those applied to structural, molecular, phenotypic, and functional product and material attributes
• Strong proficiency in principles of GMP compliance, global regulations and strong understanding of pharmaceutical analytical development lifecycle including definitive method development and lock, analytical technology transfer, phase-appropriate validation, and continuous performance monitoring
• Proficiency in leading all aspects of deviation and investigation life cycle including event identification, investigation, root cause analysis, risk assessment, corrective/preventative actions and effectiveness monitoring
• Direct experience with operational and logistical management of internal and external analytical resources including contract testing, development, and manufacturing organizations, routine testing, and stability
• Excellent oral and written communication skills complemented by focus on attention-to-detail, clarity, accuracy, conciseness, and the ability to effectively communicate complex concepts and strategy
• Action-oriented, planning-centered mindset with focus on operational excellence in a highly matrixed and integrated environment
• Ability and willingness to travel (typically to Western Europe) up to one week per month during busier periods of time; travel can be less during quieter periods
• Comfortable accommodating work during European business hours (e.g. meetings at 3-5am EST) approximately 1-2 days per week during busier periods of time; otherwise work hours are typical US Eastern Standard Time

Preferred Experience & Skills:

• Expertise in general project management and strong time management skills is highly preferred
• Practical experience managing cross-functional shared resources within and across teams in support of regulated and non-regulated testing is highly desirable
• Demonstrated knowledge with foundational concepts of pharmaceutical CMC development including the principles of “Quality by Design”, attribute criticality, specification development, integrated control strategy and life-cycle management is highly preferred

What we Value:

At our company, we hire for values first, followed by capabilities and skills. Our values guide everything we do…

Determined to Deliver:

By working with focus and passion, we can provide patients with the solutions they need.

Own Every Outcome:

We can reach new heights when we stay centered on our shared success.

Collaboration at the Core:

When we band together, our work is better.

Feedback is Fundamental:

Constructive and authentic positive feedback may be difficult to master but it is vital to our success.

Working Here:

• We offer a highly competitive compensation package with meaningful ownership through equity
• 401(k) with generous contribution
• Life insurance
• Flexible PTO policy
• Additional substantial benefits

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.