CAREERS

Altimmune offers exciting career opportunities and our projects are interesting and challenging. We also recruit and retain top-notch talent by encouraging innovation, recognizing achievements, and offering opportunities for advancement.

We are a talent force of innovative employees headquartered in Maryland and resourceful, decisive, and enthusiastic are common traits among our employees. We are looking for people from diverse backgrounds who share our passion for science and drive to develop novel life-saving vaccines, immune-modulating therapies, and treatments for liver diseases. Apply today via hr@altimmune.com.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Associate Director/ Director, Drug Product Development (DPD)

Summary of Position:

The Associate Director/Director will oversee drug production formulation and delivery device assessment at Altimmune to help develop vaccines and therapeutic products for commercial purposes. The essential duties include managing a team of scientists to lead the in-house development, as well as effectively manage external vendor teams or CMOs under tight timelines. The selected candidate will also help to maintain compliance with standard operating procedures and regulatory requirements. The position title will be commensurate with qualifications and experience of the selected candidate.

Essential Functions:

  • Responsible for formulation characterization, clinical compatibility development and drug product cGMP manufacturing process design, scale-up, and technology transfer to CMOs
  • Accountable for all process characterization and development, process validation activities, risk assessments and control strategies, as well as continued process verification for drug product
  • Develop and implement strategy for drug delivery and device selection based on the Target Product Profile, clinical indication and dosing requirements for vaccines and therapeutics
  • Provide support for phase appropriate product development strategies for the pipeline candidates as needed in alignment with FDA and ICH guidelines for biologics and/or peptide-based therapies.
  • Provide oversight and guidance of in-house development activities for lead candidates
  • Generate/Review batch records, SOPs, protocols, development reports, qualification reports and other reports as needed on a timely basis
  • Ensure scientific data and laboratory notebooks are maintained in compliance with SOP standards and guidelines
  • Provide budgetary and programmatic support for product development to align with company budgets and forecasting efforts
  • Train and/or mentor members of the internal teams as needed.

Job Requirements (Essential knowledge, skills and attributes):

  • M.S/Ph.D. degree in a biomedical related field is required. Ph.D. with 7 years, or M.S with 10 years of work experience in drug product development and/or DP manufacturing with focus on commercialization strategy.
  • Strong experience in at least one of the following fields of drug product formulation, intra nasal delivery, oral and/or subcutaneous delivery for biologics and/or peptide delivery
  • In depth knowledge of ICH and FDA guidance for biologics and peptide-based therapeutics, and their impact on drug product container closure selection strategy and planning
  • Minimum of 3 years of hands-on experience in a working in drug product formulation, fill finish activities, PPQ for drug product fill finish activities and/or device selection and development of TPP.
  • Ability to independently analyze and interpret data, ability to make keen observations regarding data and provide scientific approaches.
  • Knowledge of general budget forecasting for scientific projects, ability to learn from others, and work in a team-oriented environment
  • Supervisory experience of at least 3 years required, 5 years of supervisory experience preferred.
  • Strong communication skills; both verbal and written, and computer (e.g., MS Excel, MS Word, MS PowerPoint, MS Project).
  • Excellent organizational skills and ability to work well in a fast-paced environment.

Quality Assurance Specialist

Summary of Position:

The Quality Assurance Specialist is responsible for quality support for all activities related to the manufacture and testing of products through all phases of the clinical lifecycle. The selected candidate will have a detailed understanding of manufacturing processes, tech transfer, analytical, quality systems and GMP/GLP requirements. The essential duties will be to support product disposition, clinical trial material disposition, product testing, investigations, change control, risk assessments and quality systems. The candidate will help to create a quality-oriented culture throughout the organization.

Essential Functions:

  • Manage lot review activities for clinical material/products to ensure disposition timelines are met.
  • Review and manage deviations from contractors related to manufacturing and testing.
  • Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP/GLP expectations.
  • Communicate and resolve discrepancies with CMOs/CTLs.
  • Compile and manage lot files.
  • Assist in the preparation, execution, report and follow-up of internal and external audits.
  • Participate in quality system improvements.
  • Monitor project progress to ensure efficient and effective communication on project status and issues.
  • Author, review and revise site SOPs to ensure compliance with GDPs, regulatory requirements and corporate standards.
  • Perform other duties as assigned by Quality Management

Job Requirements (Essential knowledge, skills and attributes):

  • Bachelor of Science degree or higher in a scientific discipline is required.
  • A minimum of 5 (five) years of GMP quality assurance experience in biopharmaceutical industry is required.
  • Demonstrate a solid understanding of biologics manufacturing – process, analytical operations, quality systems and regulations.
  • Direct experience with document management, SOP development, batch record review and product disposition are required.
  • Experience in GMP/GLP record review, investigations, change control, validation and risk assessment.
  • Ability to build strong collaborative relationships with partners in and outside of the organization.
  • Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment.
  • Excellent problem-solver with the ability to work independently.
  • Experience with providing direct oversight and support to clinical material manufacturing operations is highly preferred.
  • Experience performing deviation investigations including CAPA planning and management is highly preferred.
  • Excellent attention to detail.
  • Proficient use of MS PowerPoint, Excel and Word.
  • Occasional travel up to 5-10% of time.
  • Experience performing Quality audits, a plus.

Assistant Controller

Summary of Position:

The Assistant Controller will provide the Controller and CFO with assistance on all financial-related tasks. The ideal candidate has excellent general ledger accounting skills and a passion for finding solutions to complex problems. We’re looking for a self-starting, highly detailed professional who practices discretion in all corporate matters and doesn’t mind working with monthly financial closes, multi-currency consolidations, transfer pricing and other required tasks such as stock compensation plan accounting.

Essential Functions:

  • Prepare and process detailed financial statements for each of our subsidiaries
  • Coordinate statutory financial audits with the Controller and CFO
  • AR/AP/Payroll/Fixed Assets
  • Delegate data entry tasks with junior accounting staff
  • Ensure compliance with regulatory and in-house standards and best practices
  • Assist with written budgets and reports in accordance with our needs
  • Improve internal control systems to prevent inaccuracies in financial statements
  • Oversee the reconciliation of accounts monthly/quarterly
  • Review financial data on a quarterly basis and consult with the Controller and SEC reporting personnel to resolve issues and articulate the period’s performance
  • Other tasks as assigned

Job Requirements (Essential knowledge, skills and attributes):

  • Bachelor’s Degree in Accounting required
  • Public company accounting experience required
  • CPA highly preferred
  • Big-4 experience highly preferred
  • Government contracting accounting experience preferred
  • >5 years of experience
  • MS Office 365, emphasis on Excel skills
  • Working knowledge of Costpoint 7.1 preferred
  • Experience with system implementations and GL migration preferred
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.