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Heat Biologics is a clinical-stage biopharmaceutical company and Pelican Therapeutics is a wholly-owned subsidiary of Heat. Together they are progressing a portfolio of immunotherapy products to fight cancer. In the next year, Heat/Pelican will have multiple products in numerous early phase clinical programs. This position will be based in Durham, North Carolina and the successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.

The Accounts Payable Manager is a hands-on member of this dynamic biotech start-up company. This position is responsible for all activities in the accounts payable function, ensures timely payments of vendor invoices and maintains accurate records and control reports.

Key Responsibilities:

  • Establishes and maintains financial systems to assure timely and accurate payment of all accounts payable.
  • Supervises preparation and distribution of all invoices, statements, contracts, vouchers, etc. for payment to ensure compliance with internal controls.
  • Monitor and resolve all account payable issues and administer all invoices for vendors
  • Regularly informs the Controller of the status of the payables section and makes recommendations for improvements in systems and procedures.
  • Training of personnel on use of Concur expense reporting system.
  • Ensures timely and accurate availability of status reports and information for appropriate staff.
  • Manage the 1099-Misc reporting requirements.
  • Reconciles all accounts payable general ledger accounts monthly.
  • Perform all other duties as assigned by supervisor.

Minimum Requirements:

  • BS degree in Accounting, Finance, Management or related field.
  • 5+ years of accounting experience.
  • 3+ years of relevant Accounts Payable Manager work experience.
  • Ability to prioritize, organize and manage multiple projects simultaneously.
  • Strong cross-functional interpersonal skills.
  • Excellent oral and written communication and attention to detail.
  • Proficiency in MS Office suite, including Word, Excel, and PowerPoint.
  • Experience with NetSuite and Concur software packages preferred.
Accounts Payable Manager: Apply Now

Heat Biologics is a clinical-stage biopharmaceutical company and Pelican Therapeutics is a wholly-owned subsidiary of Heat. Together they are progressing a portfolio of immunotherapy products to fight cancer. In the next year, Heat/Pelican will have multiple products in numerous early phase clinical programs. The CMC Manufacturing Project Lead will work closely with the Heat/Pelican Research & Development and Analytical teams to implement manufacturing strategies to ensure product supply to support all clinical programs. This position will be responsible for technical oversight of all manufacturing activities at CMOs - leading process technology transfers, defining batch processes/documentation and direct review of all associated contract manufacturing activities. The Manufacturing Project Lead will also participate in the definition and execution of process validation activities needed in the preparation of applications for licensure. The ideal candidate will have extensive experience and knowledge in development and manufacturing of clinical and commercial biological products. They will have complete understanding of technology transfers and GMP manufacturing of clinical trial material and will have been directly involved in late stage process validation programs in preparation for licensure. This role is highly complex and applies knowledge of CMC development and broad manufacturing expertise (upstream/downstream process steps, drug substance and drug product). This position will be based in Durham, North Carolina and the successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.

Key Responsibilities:

  • Interact/communicate with contract manufacturing and analytical laboratory organizations to coordinate process development, assay development and activities for CMC manufacturing programs.
  • Manage and lead Process Technology Transfer activities at CMOs and provide technical oversight during manufacturing campaigns.
  • Work collaboratively with CMOs, Heat Quality Assurance and Quality Control to ensure timely manufacturing and release of GMP compliant material.
  • Coordinate manufacturing trouble shooting, investigations, root cause analysis, CAPAs, impact assessment and change controls.
  • Author and/or review manufacturing documentation (e.g. Protocols, Process Description, Batch Records, SOPs, Change Controls, etc.).
  • Contribute to the writing and review of INDs and regulatory submissions.
  • Communicate project status updates and actions required to internal team members clearly and accurately.
  • Monitor project costs to maintain budget for the CMC group.
  • Assist Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
  • Perform other duties as assigned.

Minimum Requirements:

  • BA/BS degree; MS preferred in scientific discipline.
  • 5+ years of biopharma process development and/or CMC manufacturing work experience.
  • Ability to prioritize, organize and manage multiple projects simultaneously.
  • Strong knowledge of GMP/GLP manufacturing and laboratory environments/requirements and familiarity with clinical trial packaging/labeling and distribution.
  • Firm understanding of manufacturing quality systems and industry practices
  • Strong cross-functional interpersonal skills.
  • Excellent oral and written communication and attention to detail.
  • Proficiency in MS Office suite, including Word, Excel, and PowerPoint.
  • Ability to travel up to 10% as needed.
CMC Manufacturing Project Lead: Apply Now

Heat Biologics is a clinical-stage biopharmaceutical company and Pelican Therapeutics is a wholly-owned subsidiary of Heat. Together they are progressing a portfolio of immunotherapy products to fight cancer. In the next year, Heat/Pelican will have multiple products in numerous early phase clinical programs. The CMC Project Manager will work with the CMC group and manage activities at multiple CMOs and analytical contract laboratories to ensure product development project goals and milestones are achieved. This position will be based in Durham, North Carolina and the successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.

Key Responsibilities:

  • Interact and communicate with contract manufacturing and analytical laboratory organizations to coordinate process development, assay development and preclinical development programs and activities for CMC development programs.
  • Maintain detailed status updates to support multiple CMC product development projects.
  • Communicate project status updates and actions required to internal team members clearly and accurately.
  • Identify issues affecting project timelines and ensure management awareness to facilitate decision-making to mitigate such issues.
  • Maintain and ensure availability of CMC documentation necessary for regulatory filings or health authority interactions.
  • Monitor project costs to maintain budget for the CMC group.
  • Assist Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
  • Perform other duties as assigned.

Minimum Requirements:

  • BA/BS degree; PMP certification preferred.
  • 5+ years of experience in the pharmaceutical/biotech clinical research industry; with at least 3 years of relevant CMC Project Management work experience.
  • Ability to prioritize, organize and manage multiple projects simultaneously.
  • Working knowledge of GMP and GLP manufacturing and laboratory environments/requirements and familiarity with clinical trial packaging/labeling and distribution.
  • Strong cross-functional interpersonal skills.
  • Excellent oral and written communication and attention to detail.
  • Proficiency in MS Office suite, including Word, Excel, and PowerPoint.
  • Ability to travel up to 10% as needed.
CMC Project Manager: Apply Now

Heat Biologics is a clinical-stage, biotechnology company, focused on the development and commercialization of novel immunomodulators and cancer immunotherapy products.  We are an innovative and growing company and have a highly energized and accomplished team.

  

Position Information

We are seeking a highly motivated immunology PhD scientist with expertise in autoimmunity and inflammation as it relates to animal models and immunoassay, development, for the role of Research Scientist I.  The position will be based in Research Triangle Park, North Carolina and will directly report to the Executive Director of Research in the Heat Research Group (HRG).  This role will be responsible for building out a new function focused on testing drug candidates for efficacy in animal models of inflammation and will represent a subject matter expert for inflammation & autoimmune indications in the lab.

This is a wet lab function; you will perform studies and be responsible for mentoring and training technicians.  This function has no direct reports, it is an individual contributor role and will complement similar cancer immunology roles internally.  This role will be required to build study designs that is in-line with the company’s goals, analyze results, build study reports and present results internally.

 

Role’s Function

You will work in a team and support preclinical development of novel immunology, small and large molecule, preclinical programs.  Your responsibilities will include the development and execution of experimental strategies to define biomarkers of target engagement, mechanism of action and mechanism of resistance to therapeutic agents.  You will perform in vitro and in vivo experiments to determine the functional effect of candidate target activation/inhibition by using a variety of assays to interrogate immune endpoints.  You will be expected to keep abreast of published scientific literature and present your data at internal group meetings.  You will also be responsible for synthesizing study reports, scientific posters and manuscripts.

The successful candidate will be an individual contributor with deep scientific curiosity, excellent oral and written communication skills, work well independently and as part of a collaborative team.

 

Required Experience:

  • Expertise and deep knowledge in immunology, autoimmunity, tolerance and inflammation is required
  • Hands-on experience with the development of in vivo mouse models for inflammation and autoimmune diseases required
  • Expertise with multi-parameter flow cytometry and analysis software, developing in vitro and in vivo assays to investigate immune function and possessing a deep knowledge of technologies commonly used to assess immune endpoints, required
  • Hands-on, working experience with various immunoassay techniques such as T & B-cell ELISPOTs, cytokine ELISAs, measuring serum Ab titers, and Western blots, required
  • Candidate should be competent in standard scientific software used for data analysis (e.g., Microsoft Excel) as well as Microsoft Word, PowerPoint, FlowJo and GraphPad Prism
  • Ability to adapt to rapid changes in project priorities, define and meet aggressive timelines
  • Committed to working in a small, collaborative manner across functional areas within a matrixed organization
  • Candidate will be required to keep a notebook and record findings. Good data handling and recording skills as well as the ability to interpret moderately complex data sets and draw appropriate conclusions, required
  • Candidate should be a strong team player with demonstrated ability to work independently to design experiments, interpret data, troubleshoot and suggest next steps

 

Required Education:

  • PhD in immunology
  • Completed postdoctoral fellowship (3 years minimum) in a relevant discipline – inflammation or autoimmunity
  • 0-2 years of industry experience
  • 5+ years of working, hands-on experience with in vivo mouse model development for inflammatory diseases
  • 5+ years of working, hands-on experience in vitro/ex vivo immunoassay development
  • 5+ years of flow cytometry and data analysis experience
  • 4+ years technical experience with mammalian cell culture and molecular biology techniques as it relates to this job description

 

Knowledge in these areas a plus, but not required, for this position:

  • Pharmacodynamic models such as DTH, Air-pouch model (APM), Acute DSS-induced and TNBS-induced IBD, CAIA arthritis, and acute dermatitis
  • Human immunology experience and working with human PBMCs
  • Knowledge with GVHD models and assays
  • Knowledge of therapeutic areas including Rheumatology, GI, Neuroimmunology, and/or Respiratory
  • Experience mentoring and training technicians

 

 We offer a competitive compensation and benefits package as well as an environment where your contributions can make a significant difference.

Research Scientist I – Autoimmunity/Inflammation/In Vivo Pharmacology: Apply Now