Senior Scientist I/II – Formulations

 

Ashvattha Therapeutics, a clinical stage biopharmaceutical company located in Redwood City, is seeking a Sr. Scientist I/II, Formulations.  Ashvattha Therapeutics is focused on developing novel nanomedicines, HD therapeutics (HDTs), to treat unmet medical needs in ophthalmology, neurology, inflammatory diseases, and neuro-oncology. Our HD platform builds therapeutics that are selectively taken up only by inflamed tissues, allowing us to treat diseases with unprecedented precision.

 

We are seeking to recruit a highly motivated Sr. Scientist I/II with a strong background and experience in formulation science to develop parenteral and oral formulations of our nanomedicine therapeutics. The responsibilities of this position include developing initial formulations of candidate nanomedicines for testing in animal studies in collaboration with Chemistry and Translational teams.  Early pre-formulation work for parenteral administration will be conducted with nanomedicines produced by the Chemistry team.  For nanomedicines in development or designated for development, the candidate will lead the formulation development efforts to transition from parenteral to oral dosage forms. 

 

Candidate will work with Manufacturing team to scale-up drug product formulations of our nanomedicine products at Contract Manufacturing Organizations (CMOs) for GLP and GMP production to support toxicology and clinical studies. The candidate will be both “hands on” in laboratory work with the Chemistry and Analytical teams to formulate non-GLP toxicology scale lots.  The candidate will have demonstrated experience working with cross functional teams (chemistry, translational, manufacturing, analytical) in a pharmaceutical or biotechnology company. 

 

The candidate will also have managed CMOs or internal teams for production of injectable and oral dosage forms.  Candidates should have some experience in writing CMC sections of IND and various regulatory documents (formulation development section) as well as knowledge of GLP and GMP requirements.

 

Duties and Responsibilities - Essential Functions

 

·       Evaluate the stability of lead nanomedicines and collaborate with Analytical on stability data analysis and developing stability indicating methods.

·       Work with Chemistry team to develop prototype parenteral formulations for Translational team.

·       Conduct Preformulation studies to develop solid dosage forms of lead nanomedicines and assist in development of late stage nanomedicines.

·       Manage injectable and oral dosage form development and scale-up at CMOs as appropriate.

·       Collaborate with Analytical team to establish in-house short-term stability programs to evaluate stability of prototype formulations and the  lead nanomedicines drug candidate and the reference standards

·       Provide input on potential degradation pathways of drug candidates to Chemistry team to support drug design.

·       As required, write formulation development and stability reports and formulation development sections of regulatory documents (e.g., Pre-IND, IND, and NDA)

·       Write formulation and administration sections of GLP toxicology protocols and clinical protocols and Investigator Brochure

·       Collaborate with the Analytical team to design and conduct stability studies on drug substance and drug product in support of clinical studies (shipping, handling, and pharmacy)

·       Write Pharmacy Manuals to support clinical trials, as needed.

·       Lead formulation development discussions with CMO for production of nanomedicine therapeutics

·       Represent Formulation team at various multidisciplinary teams such as CMC and Project Team meetings.

 

 

Job Requirements

 

·       PhD with at least 5 years of relevant experience in pharmaceutical or biotechnology company

·       Experience in hands-on injectables and solid dosage form formulation development of small molecule drug candidates and preferably dendrimers

·       Experience taking early research formulations through scale-up and GMP production of injectables and oral dosage forms.

·       Hands-on experience in analytical techniques, such as Liquid Chromatography (HPLC, UPLC), GPC, DSC, TGA, and X-ray

·       Hands-on experience with developing parenteral dose forms for IV and subcutaneous and oral dosage forms including tablets, capsules, and suspensions

·       Self-motivated, , detail-oriented and able to work in a fast-paced team environment with demonstrated problem solving skills.

·       Knowledge of GLP & GMP requirements and lyophilization principles

·       Outstanding presentation, writing, and communication skills

·       Demonstrated skills in working with a diverse team and external CMOs.

·       Forward-thinking and creative with high ethical standards

·       Strategic thinker with sound technical skills, analytical ability, good judgment and strong operational focus

·       Well organized and self-directed

        Must be able to work on-site at our Redwood City Laboratory 5 days per week

 

 

What We Can Offer You

 

This is a unique opportunity to join a team focused on the development of a new class of precision medicines that selectively treat diseased cells in regions of inflammation. By making precision medicine even more precise, our nanomedicine technology has the potential to change the standard of care across ophthalmology, neurology, inflammatory diseases and neuro-oncology.​ You will have the opportunity to learn new skills and gain a better understanding of the cutting-edge technology.  

 

We have a comprehensive total compensation package including fully paid medical, dental and vision benefits for you and your family.  We want all of our employees to have the opportunity to become shareholders and offer new hire stock options.  The Company also offers participation in the annual bonus program.  The salary range for this position is $120,000 – $160,000 annually. We consider various factors when determining the base compensation, including market survey data, experience, qualifications, and geographic location, which means that the actual compensation may vary.

 Ashvattha does not accept unsolicited resumes or applications from agencies.  We are not responsible for any fees related to unsolicited resumes/applications.