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Process Development Scientist

GIVAX is a Venture Capital-backed biotech company founded through RA Ventures’ incubator. GIVAX is utilizing a novel vector-based vaccine platform to address unmet public health needs in the prevention of infectious gastrointestinal diseases.


SUMMARY:

We are seeking an energetic and motivated scientist to join GIVAX. In this role, you will be part of a team that is working on the molecular biology and immune evaluation of viral vector backbones and candidate vaccine viruses. As a Process Development Scientist, you will be responsible for supporting the team in moving the vaccine/s into clinical ready products for Phase 1 and beyond. You will have the opportunity to work with some of the world’s leading scientists in the field of vaccine development to bring our flagship program from discovery to industrialization. We are seeking an innovative mind with expertise in viral molecular biology and particularly reverse genetics technology.


Leveraging previously acquired academic and/or work experience, the Process Development Scientist will be responsible for development of a small-scale manufacturing process, formulation development and development of methods to characterize the product and process. The incumbent will report to the Technical Project Lead and will also work in close collaboration with the Head of Operations. In addition to the internal staff, the incumbent will work in close collaboration and key partners to plan and execute the research that will lead to the generation of our vaccine candidates.


RESPONSIBILITIES
  • Please note: The percentages listed below are related to the expected effort distribution for this role.

Laboratory Research (70%)
  • Develop small-scale manufacturing process based on licensed live attenuated rotavirus vaccines, optimized for maximized yield and recovery.
  • Source and test animal origin free, chemically defined reagents to use in manufacturing process.
  • Execute process development experiments to support process definition.
  • Plan and run experiments to select best formulation based on licensed LAV rotavirus vaccines.
  • Develop methods to characterize the process, drug substance and drug product.
  • Generate tech transfer package to support hand-off to CDMO to produce clinical material.
  • Interact with CRO/CDMO team members, and other SMEs as dictated by project needs.
  • Ensure that work is performed following current, phase-appropriate regulatory and quality compliance requirements.
  • Maintain knowledge of new scientific literature directly related to GIVAX programmatic priorities.

Project Management (15%)
  • In collaboration with Vaccine Project Head, create and monitor experimental plans, cost estimations, schedule, and resourcing plan
  • Engage with external partners and other SMEs as dictated by project needs
  • Monitor key milestones, decision points, and critical path activities associated with his/her function to ensure timely achievement of project deliverables.
  • Identify and assess risks and roadblocks, and develop mitigation plans to address risks

Internal Affairs (15%)
  • Provide support to Senior Leadership to achieve the company mission.
  • Interact with colleagues transparently and cooperatively, contributing to an open exchange of ideas among team members.
  • Ensure efficient and agile communication of key information, processes, workflows, and operational elements in various circumstances. 


POSITION DETAILS
  • Hands-on lab role
  • Reports to the Vaccine Project Head
  • Title will commiserate experience
  • Location: Philadelphia, PA


EDUCATION LEVEL
  • PhD in life science discipline or equivalent years’ experience required
  • Authorization to work in the United States required


BASIC QUALIFICATIONS
  • PhD in a life science discipline with >1 year of postdoctoral experience
  • Scientific publications in virology
  • Minimum 5 years of experience in basic research


PREFERRED QUALIFICATIONS
  • Experience working in process development for live attenuated viral vaccines
  • Experience in working with infectious diseases (BSL2 or above)
  • Working knowledge of virology, immunology, molecular biology, and protein chemistry.
  • Experience in vaccine early- and/or late-stage development and manufacturing.
  • Ability to work in cross-functional teams effectively and to build strong relationships with partners.
  • Ability to work independently and take personal initiative to complete tasks.
  • Strong organizational/time management skills and ability prioritize tasks.
  • Flexibility and willingness to support the team in execution of project goals.
  • Excellent written and oral communication skills, fluency in English (written and spoken).


Average salary estimate

$85000 / YEARLY (est.)
min
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$70000K
$100000K

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What You Should Know About Process Development Scientist, GIVAX

At GIVAX, a dynamic Venture Capital-backed biotech company located in the heart of Philadelphia, PA, we're on a mission to tackle public health challenges through innovative vaccine solutions. We're looking for a passionate and dedicated Process Development Scientist to become an integral part of our team. In this role, you'll dive into the exciting world of molecular biology and contribute to the development of viral vector vaccines aimed at infectious gastrointestinal diseases. Collaborating closely with leading scientists, you'll translate research into clinical-ready products, focusing on small-scale manufacturing processes, formulation development, and product characterization. With your expertise in viral molecular biology and reverse genetics technology, you'll lead experiments designed to maximize yield and recovery, ensuring compliance with regulatory and quality standards. Not only will you engage in hands-on lab research, but you'll also play a crucial role in project management by strategizing experimental plans and collaborating with external partners. If you thrive in a fast-paced, innovative environment and are ready to make a significant impact in vaccine development, we would love to hear from you. Join us at GIVAX and help shape the future of public health with your scientific prowess!

Frequently Asked Questions (FAQs) for Process Development Scientist Role at GIVAX
What are the key responsibilities of a Process Development Scientist at GIVAX?

As a Process Development Scientist at GIVAX, you'll primarily focus on developing small-scale manufacturing processes for our viral vector vaccines. Your responsibilities will include conducting laboratory research, optimizing yield, sourcing reagents, running process development experiments, and generating tech transfer packages for clinical material production. You'll also support project management by engaging with stakeholders and monitoring project milestones.

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What qualifications are required for the Process Development Scientist position at GIVAX?

To be considered for the Process Development Scientist role at GIVAX, candidates need a PhD in a life science discipline, alongside a minimum of one year of postdoctoral experience. Additionally, candidates should have relevant scientific publications in virology and substantial experience in basic research, along with preferred qualifications that include experience in the development of live attenuated viral vaccines and working knowledge in virology, immunology, and molecular biology.

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What skills are important for success as a Process Development Scientist at GIVAX?

Success in the Process Development Scientist role at GIVAX hinges on a combination of technical expertise and soft skills. Key skills include strong organizational and time management abilities, excellent communication skills, and the capacity to work effectively in cross-functional teams. Moreover, candidates should demonstrate personal initiative, adaptability, and a collaborative approach to problem-solving in the lab.

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What does the laboratory research component entail for the Process Development Scientist at GIVAX?

The laboratory research component is a significant part of the Process Development Scientist's role at GIVAX, constituting about 70% of the responsibilities. This involves developing and optimizing small-scale manufacturing processes, conducting experiments to select the best formulations, and characterizing the drug substances and products. laboratory research is critical to achieving the project's goals and supporting our vaccine development pipeline.

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How does the Process Development Scientist collaborate with team members at GIVAX?

Collaboration is key for the Process Development Scientist at GIVAX. You'll interact closely with the Technical Project Lead, Head of Operations, and external partners to ensure smooth execution of projects. This partnership will involve open communication, sharing ideas, planning experiments, and working together towards a common goal of developing effective vaccines for clinical use.

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Common Interview Questions for Process Development Scientist
Can you describe your experience with viral molecular biology relevant to the Process Development Scientist role?

In responding to this question, focus on specific projects or roles where you applied your knowledge in viral molecular biology. Highlight any experience you have with viral vector systems, reverse genetics technology, or related techniques. Providing examples will demonstrate your technical expertise and ability to contribute to GIVAX.

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What strategies do you use to optimize small-scale manufacturing processes?

Share your methodology for process optimization, discussing any particular approaches, tools, or experimental designs you've employed in past roles. Explain how your analytical skills help you assess yield and recovery rates and mention any specific successes you've had in improving manufacturing efficiency.

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How do you ensure compliance with regulatory and quality standards in your work?

Detail your understanding of regulatory frameworks relevant to biotech processes and how you incorporate compliance checks in your experiments. Discuss your experience in maintaining documentation, following SOPs, and collaborating with quality assurance teams to uphold high standards of practice.

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Can you explain your project management experience as it pertains to vaccine development?

Talk about your experience in managing timelines, resources, and stakeholder communications within vaccine development projects. Describe how you prioritize tasks and tackle risks, ensuring that you meet project milestones and deliverables in a cross-functional team environment.

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What challenges have you faced in vaccine process development, and how did you overcome them?

Use this opportunity to illustrate your problem-solving skills. Discuss specific challenges you've encountered in past roles, such as scaling up production or formulation stability issues, and detail the steps taken to address these problems effectively.

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How do you keep up with the latest advancements in virology and vaccine research?

Employ this question to demonstrate your commitment to continuous learning. Discuss the journals you read, conferences you attend, or networks you engage with to stay updated on the latest research. Show how this awareness can benefit your role at GIVAX.

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Describe your experience in working with cross-functional teams.

Illustrate your collaborative skills with examples of successful teamwork in past roles. Emphasize your ability to communicate effectively with individuals from diverse backgrounds, including R&D, regulatory affairs, and manufacturing, to drive projects forward.

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What do you consider the most exciting aspect of vaccine development?

Share your passion for the field by discussing what motivates you about vaccine development. This could include the impact on public health, the challenge of overcoming scientific obstacles, or the satisfaction of bringing a product from concept to clinical trial.

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Can you discuss a specific publication of yours related to virology?

Talk about a noteworthy publication, detailing the research focus, your contributions, and the implications of the findings. Highlighting your ability to contribute to the scientific community will show how your work aligns with GIVAX's mission.

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What role do you see yourself playing in the GIVAX team as a Process Development Scientist?

Reflect on how your skills and experiences align with the company's goals. Use this as a chance to express your enthusiasm for becoming an essential part of the GIVAX team, focusing on your collaborative spirit and technical expertise that can help advance vaccine development.

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TEAM SIZE
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LOCATION
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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
December 30, 2024

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