Associate Director, Pharmaceutics

Ardelyx

Fremont, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 02/26/2021
  • Website: ardelyx.com
  • Company Address: 34175 Ardenwood Blvd., Fremont, CA, 94555

About Ardelyx

Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines.

Job Description

Ardelyx is a publicly traded biotech company focused on improving the lives of patients by developing and commercializing first-in-class targeted therapies that advance patient care. Using our discovery model, Ardelyx scientists have characterized new biological mechanisms and pathways that have enabled us to develop a pipeline of drug candidates to manage complications related to kidney and cardiovascular diseases. Our lead candidate, tenapanor, is a first-in-class small molecule therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis. If approved, tenapanor could completely change the treatment paradigm in a disease state with significant unmet need.  We are advancing the build of our commercial organization to be prepared for launch of tenapanor in mid-2021.


Associate Director, Pharmaceutics

Purpose of the role:

The Associate Director, Pharmaceutics is a self-motivated and creative individual who works as a member of an integrated CMC team developing novel formulations for the Ardelyx pipeline. This individual can work independently as well as, lead a formulation team to perform investigation and research to resolve pharmaceutical issues. This individual can manage drug product development during clinical stages as well as, provide oversight for technology transfers or troubleshoot issues encountered during commercial batch manufacturing. This person should have a deep understanding of techniques required to evaluate the physicochemical properties of small molecule drug candidates as well as, techniques used to assess biopharmaceutics/pharmacokinetics aspects such as, drug absorption, bioavailability, and bioequivalence.  This individual will collaborate with research functions, including discovery chemistry, DMPK, in vivo and in vitro pharmacology and parallel CMC functions such as process chemistry and analytical development. Additionally, this individual is expected to have extensive experience in regulatory submissions for marketing authorizations such as NDA/MAA or other global submissions and would have gone through negotiations with health authority prior to those submissions.

Position Responsibilities: 

  • Design and develop optimal formulations, and robust, scalable & cost-effective processes for the manufacture of DPs for clinical studies and commercialization. Design and implement efficient DOE's to support formulation and process robustness.
  • Engage with API process chemistry group to ensure drug substance with optimal physicochemical properties is advanced towards commercialization. Support material characterization efforts - solid state form, mechanical attributes, particle size assessment, physicochemical stability, etc.
  • Provide technical input to cross-functions towards clinical dosage form bridging strategies and to manage potential scale-up and post-approval changes.
  • Support screening and selection of CRO's & CDMO's for drug product, and lead R&D activities for product development and manufacturing at internal and external sites. Work cross functionally with analytical, regulatory, clinical and related teams to achieve program objectives.
  • Provide oversight for manufacturing activities at the CMO or CDMO as person-in-plant when required.
  • Author / review manufacturing batch records and study protocols. Author / coordinate preparation of high-quality technical reports and integrated project summaries.
  • Author/ review CMC regulatory documentation for IND, NDA and IMPD filings, covering all phases of clinical development in both the US and ex-US markets. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external publications and relevant industry benchmarking information to efficiently design product development strategies.
  • Represent product development function and present work at intra/inter departmental meetings.
  • Mentor junior scientists and develop future leaders

Position Requirements: 

  • Ph.D. in pharmaceutical sciences or chemical engineering
  • 12+ years’ experience working as a formulation scientist in the pharmaceutical industry
  • Flexible and adaptive team player with excellent verbal and written communication skills
  • Deep understanding of physio-chemical properties and pre-formulation characteristics of small molecule drug candidates
  • Broad knowledge of and experience with different formulation types (solutions, suspensions, capsules, tablets, etc) and excipients for different delivery routes (PO, IV, IP, SC, topical, osmotic pumps, etc) in animal species and in humans
  • Experience with solid-state characterization techniques, including DSC. TGA, XRPD, SEM, DVS and particle size distribution analysis
  • Experience with solubility and dissolution rate assessments
  • Experience with cGMP guidelines and GLP laboratory requirements
  • Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science or Chemical Engineering
  • Highly skilled in formulation design and process development of immediate & modified release oral solid dosage forms. Expert in pharmaceutical manufacturing processes including dry/wet granulation, compression, coating and packaging.  Experience with fixed-dose combination products is a plus.
  • Ability to independently design and implement study plans & DOE's related to drug product & process development, conduct risk assessments and delineate risk mitigation strategies (FMEA).
  • Experience in technology transfer of drug product to clinical & commercial drug manufacturing sites, including management of activities at CDMO's.
  • Extensive experience in authoring regulatory submissions (IND, NDA, MAA), development reports, batch records, protocols and associated reports (PDR, QbD, Validation).
  • Ability to travel up to 25% domestically and internationally (post-COVID 19 pandemic).

 

As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients.  It’s the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines.  We are different for good.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.