At Axcella Health, we are a biotechnology company pioneering the research and development of novel multifactorial interventions to support health and address dysregulated metabolism across a broad spectrum of consumers and patients who have limited options. Our AXA Candidates are generated from our proprietary, human‑focused AXA Development Platform and harness the power of endogenous metabolic modulators (EMMs), a broad family of molecules that fundamentally impact and regulate human metabolism.
Using our AXA Development Platform, we have rapidly generated a pipeline of AXA Candidates that are novel compositions of EMMs engineered in distinct ratios and designed to target and maximize the fundamental role that EMMs play in regulating multiple metabolic functions. Our platform has produced a rich pipeline of AXA candidates with programs focused on the metabolic functions of the liver, muscle, and blood.* We are developing our lead AXA Candidate, AXA1665, as an investigational drug product for hepatic encephalopathy (HE). We have not made a development path decision for our other AXA Candidates.
Joining Axcella Health offers the potential to be part of a groundbreaking organization pioneering the research and development of novel multifactorial interventions to support health and address dysregulated metabolism across a broad spectrum of consumers and patients who have limited options. We are growing quickly as we advance in the clinic, and we are seeking exceptional people to join our team. We value bright minds, collaborative spirits and a willingness to think outside the box.
Chemistry, Manufacturing, and Controls (CMC) is responsible for the development, scale-up, CRO/CMO selection, tech transfer, and characterization of a novel class of drug products designed to target multifactorial diseases. In addition, CMC provides formulation expertise, supports Research and Development (Toxicology, DMPK, Clinical) efforts, evaluates new technologies, and develops platform technologies suitable for incorporation into clinical/commercial manufacturing processes.
This scientific leadership role will report to the Executive Director of Formulation, Manufacturing, & Supply Chain and be responsible for formulation strategy, development and optimization within the Axcella platform in a dynamic and highly interdisciplinary environment. He/she will develop and integrate innovative formulation development strategies and plans, in alignment with evolving cross-functional and project team goals and activities. The successful candidate will also oversee strategic vendor partner selection and drive technical and operational activities in collaboration with external organizations. This individual also must ensure that the highest standards of safety and environmental compliance are maintained in the workplace and must operate under the regulatory requirements for Pharmaceutical product development and manufacturing.
- Assess and characterize physiochemical properties of raw materials and drug products to design phase appropriate pre-clinical and clinical oral solid, solution and/or suspension formulations.
- Utilize state of the art methodology to develop both platform and novel formulations for potential drug product candidates.
- Establish appropriate in vitro and in vivo assessment methodologies for formulation development.
- Collaborate with partner function lines, including Research and Development to achieve project deliverables and timelines.
- Stay current with new developments and technologies in areas of formulation, manufacturing and analytical.
- Author and review drug product formulation-related sections for regulatory filings and technical development reports.
- Support scale-up and product/process transfer to contract manufacturing sites, including all related technical documentation (e.g., Product/Process development protocols and reports, BoM, Specifications, Batch Records, etc.).
- Serve as technical representative and company liaison at contract manufacturing sites.
Education and Experience
- M.S. or Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering or closely related field.
- 7+ years of relevant industrial experience in formulation development and manufacturing of oral small molecule pharmaceuticals.
- Solid fundamental understanding of biopharmaceutical and physicochemical properties relevant to oral small-molecule formulation design and development; parenteral formulation development experience is desired, but not required.
- Extensive experience with formulation technologies for low solubility molecules (e.g. nanoparticles, lipids, amorphous dispersions, etc.). Expertise in balancing between fit-for-purpose and/or novel formulation strategies based on demand requirements.
- Experience with age-appropriate novel formulations (flavorants, taste masking, etc.) to deliver drug products for oral administration.
- Familiarity with designing appropriate placebo formulations for double blinded clinical studies.
- Extensive knowledge of Biopharmaceutics with respect to formulation modality is desired.
- Experience with standard powder processing approaches such as wet and dry granulation, multi-particulate coating, spray-drying, hot melt extrusion, etc. is highly desired.
- Experience and/or knowledge in pre-formulation, formulation development, process development/scale-up, and technical transfer to contract manufacturing organizations.
- Experience with US and international regulatory requirements and quality guidelines of the biopharmaceutical industry.
- Experience and/or knowledge in developing and utilizing analytical methods for drug product testing, such as HPLC, mass spectrometry, near-infrared spectroscopy, and dissolution.
Skills and Attributes
- Broad understanding of scientific, engineering and manufacturing principles and techniques used in formulation development, associated analytical techniques, and solids/powder processing unit operations.
- Conversant with/in design of experiments (DOE), multivariate analysis (MVA), and other techniques used to determine the design and operating space for formulations.
- Proven record of achieving formulation goals under aggressive timelines and cost effectiveness through effective internal and external collaborations is essential.
- Willingness to be “hands-on”, adaptable and flexible in a dynamic, fast-paced work environment.
- Exhibits the highest degree of professionalism, respect and integrity.
- Self-motivated, creative, innovative, scientifically curious, detail oriented, and well organized.
- Positive team building and teamwork skills: Innate ability to influence, lead and inspire people, within function and beyond functional/company boundaries.
- Possesses excellent interpersonal and communication skills, both written and oral.
EEO Statement: Axcella Health is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies: Axcella Health does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Axcella Health Human Resources.
*Axcella Health conducts Non-Investigational New Drug (IND”), Institutional Review Board-approved Clinical studies to evaluate the safety and tolerability of our AXA candidates in human subjects, or effects on the normal structure or function of the body. Studies intended at the time of initiation to support drug development will be conducted under an IND.