Senior Scientist/Principal Scientist, Analytical Sciences & Operations

Stealth Mode Biotech; Philadelphia (Philadelphia County); On-site; USD 100,000 - 125,000; Full time

Job summary

An innovative biotech startup is seeking a Senior Scientist/Principal Scientist to lead analytical sciences and operations. This role is pivotal in developing novel cell therapies for cancer treatment, requiring expertise in analytical development and quality control. As part of a collaborative team, you will drive the establishment of systems and processes that support our cutting-edge CMC and GMP strategies. Join us in making a significant impact on cancer patients' lives through rigorous scientific exploration and teamwork. This is an exciting opportunity for passionate individuals ready to contribute to groundbreaking advancements in biotechnology.

Benefits

401(k) with generous contribution

Life insurance

Flexible PTO policy

Medical insurance

Vision insurance

Paid maternity leave

Paid paternity leave

Disability insurance

Qualifications

• Ph.D. or Master's with extensive experience in analytical development.
• Proficiency in GMP compliance and quality control processes.

Responsibilities

• Lead analytical development and operations for product portfolio.
• Interface with external partners for testing and quality assurance.

Skills

Analytical Development

GMP Compliance

Quality Control

Communication Skills

Project Management

Education

Ph.D. in Immunology, Cell Biology, Molecular Biology, or Biochemistry

Master’s Degree in a relevant field

Tools

Analytical Platforms

GMP Systems

Job description

Senior Scientist/Principal Scientist, Analytical Sciences & Operations

Join to apply for the Senior Scientist/Principal Scientist, Analytical Sciences & Operations role at Stealth Mode Biotech

Senior Scientist/Principal Scientist, Analytical Sciences & Operations

Join to apply for the Senior Scientist/Principal Scientist, Analytical Sciences & Operations role at Stealth Mode Biotech

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Lead Recruiting Consultant for a Stealth Stage Biotech Company

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

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Stealth Mode Biotech by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

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