Working at Altavant

Altavant is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.

See current job openings at Altavant Sciences below.

Associate Director, Biologics CMC 

Altavant is seeking an Associate Director of CMC to play a critical high-level role providing strategic oversight and end-to-end supervision of all CMC operational activities related to one or more of Altavant’s clinical development programs. This person will be responsible for ensuring that CMC timelines stay on track and will be the key point of contact between Altavant and all vendors and consultants that support CMC. A successful candidate will have a demonstrated track record of technical and program leadership.

This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of biologics for lung diseases. This is a high-profile position with the opportunity to innovate in an entrepreneurial and high growth organization.

RESPONSIBILITIES AND SKILL REQUIREMENTS:

  • Play a key role in advancing experimental therapeutic molecules to the clinic by providing planning, expertise and oversight on all CMC-related activities and issues, including but not limited to cell line development (including GMP MCB), process development (upstream, downstream, formulation), analytics, release assays, GMP DS manufacturing, GMP DP manufacturing, device performance and selection, label/pack/storage/distribution, regulatory activities, QC/QA
  • Ensure that CMC-related applications, such as CTAs and INDs, are complete, well written, and meet all relevant agency requirements and standards
  • Proactively identify CMC risks and provide recommendations on mitigation
  • Represent CMC at program team meetings providing timely updates on progress and recommendations on strategy with ability to effectively communicate subject matter specific topics to a non-CMC audience and senior leadership
  • Ensure that CMC activities remain within projected timelines and budget
  • Identify, review and select the best external CROs, CDMOs and key consultants that are needed to allow smooth, efficient and cost-effective CMC support for programs advancing to the clinic

EDUCATION AND EXPERIENCE:

  • Master’s Degree or PhD in a pertinent scientific discipline with at least 12+ years of industry experience in CMC
  • Proven track record of successful CMC project management experience supporting early stage programs
  • Experience in early drug development including the transition of novel candidates from discovery through to IND, Phase 1 and Phase 2 clinical trials
  • Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
  • Experience working with CMC budgets both in development and managing budgets
  • Strong knowledge of current Good Manufacturing Practices (GMP), including familiarity with CMC operations, including Quality and Manufacturing technical strategy
  • Strong knowledge of project management tools and software

CAPIBILITIES

  • Ability to act decisively and with urgency to solve problems
  • Strong leadership and interpersonal skills in order to influence decision-making in a diplomatic manner
  • Excellent oral and written communications with ability to present data to all levels of expert and non-expert audiences
  • Accountability and self-awareness to drive positive results
  • Strong Vendor Management skills
  • Effective organizational and planning skills
  • Flexibility to switch from strategic thinking to operational details
  • Ability to travel as needed

Please CLICK HERE to apply to this role (https://www.linkedin.com/jobs/view/2425899302/).


Director/Senior Director Immunology 

Altavant Sciences (Altavant.com) is a patient-centric, clinical stage biotechnology company focusing on innovative therapies for rare respiratory diseases. Altavant is seeking a Director / Senior Director with expertise in immunology to join the translational medicine team. The successful scientist will have a strong track record in drug discovery and development addressing immune and inflammatory pathways, and how their dysregulation can contribute to acute and chronic disease processes.

This role will report directly to the VP, Research and Development and will be responsible for leading nonclinical programs, nonclinical studies, internal teams, and managing external vendors in progressing the development of small and large molecule therapeutics.  

This scientist will be based within the translational medicine team and will interface with other teams including clinical to provide expertise for clinical study design and medical liaison activities.

Altavant is based in Cary, North Carolina; however, the position is open to candidates wishing to work remotely augmented with visits to the office for key meetings or team discussions after Covid-related travel restrictions are lifted. Altavant does not have laboratories and performs research and development studies at qualified vendors or as collaborations with academic institutions.

RESPONSIBILITIES & SKILL REQUIREMENTS:

  • Design, implementation, oversight and interpretation of in vitro primary cell-based assays and nonclinical in vivo disease models. This will include selection of clinically-relevant endpoints, selection and qualification of biomarkers, translation of findings to characterize mechanism of action, predict human equivalent doses, and inform clinical study design – particularly those establishing proof-of-concept.
  • Support development, qualification/validation, and application of immunoassays.
  • Design and development of robust nonclinical data packages to support IND and BLA submissions.
  • Author nonclinical pharmacology and immunology sections of regulatory filings.
  • Author and review meeting abstracts and manuscripts for publication in peer-reviewed journals.
  • Contribute to exploratory target and biomarker identification and qualification/validation.
  • Participate in the review of business development opportunities.

EDUCATION AND EXPERIENCE:

  • Ph.D. in immunology or related discipline with major immunology component, with a minimum of 5+ years of biopharmaceutical development experience.
  • Experience in respiratory drug development is desirable but not required.
  • In depth expertise on innate and adaptive immunity including an understanding of immune regulation, lymphocyte and cytokine biology, and the consequences of chronic and dysregulated inflammatory responses.
  • Track record in supporting nonclinical development programs for large (biological) therapeutics including an understanding of Regulatory Agency expectations is desirable.
  • Experience with techniques used for biopharmaceutical characterization and development of biologics including: qPCR, SPR, immune cell isolation and characterization by multi-parameter flow cytometry (Cytobank, FlowJo, MACS) and other in vitro functional assays, immunoassays including multiplex, cytokine assays, immunohistochemistry, and structure-function relationships for therapeutic proteins.
  • Experience in data analysis to support pharmacokinetics (PK) and PK-pharmacodynamics (PK/PD) is desirable, as is broad experience of all functional areas of early drug development including toxicology, nonclinical pharmacology, drug metabolism, translational biology, and Phase 1/2 clinical development.
  • Experience in authoring non-clinical regulatory submission documents (e.g. IND, NDA/BLA, IBs).

CAPABILITIES:

  • Strong communication skills, including ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience.
  • Developing track record of publications including peer reviewed manuscripts, abstracts and poster/oral presentations.
  • Proven ability to work at a high level of integrity, accuracy, and attention to detail.
  • Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions.
  • Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships to strengthen decision-making.
  • Resourceful, enthusiastic, and results-oriented.
  • Ability to travel up to ~15% as needed when Covid-related restrictions expire. Travel will mostly comprise visits to the Altavant office if working remotely, conference attendance and study-related visits to vendor laboratories.

Please CLICK HERE to apply to this role (https://www.linkedin.com/jobs/view/2524224792/).