Associate Scientist I/II, Stability Programs

Location
San Diego, California
Posted
Jul 03, 2021
Ref
oh8nffwL
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Company Overview 

At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.

Job Summary 

We are seeking an Associate Scientist I/II who is experienced, highly energetic, and committed to developing and executing our stability strategy across all GMP and non-GMP programs.  This individual will implement and oversee Avidity’s testing strategy per ICH guidelines and ensure adherence to FDA/EMA regulations.  As Avidity advances programs into the clinic, an effective stability strategy is critical to establish our drug substance retest period and drug product expiry dating. Avidity is seeking an effective leader and collaborator to develop and manage across multiple programs at various stages of CMC development.  This individual will provide operational and strategic input to cross-functional teams and ensure effective communication and with colleagues and business partners.  The Associate Scientist I/II, Stability Programs will report to the Senior Director, Formulation and Analytics and be a part of Avidity’s growing CMC/Technical Operations team.

Essential Duties and Responsibilities  

  • Coordinate the work associated with all ongoing and new stability studies.
  • Maintain oversight of Avidity’s stability strategy and ensure consistency across all development programs.
  • Review and approve stability protocols and data generated by third-party testing laboratories ensuring adherence to ICH guidelines.
  • Conduct data analysis, generate trending reports, and review raw data for Certificate of Analysis (CoA).
  • Coordinate the work of Avidity’s stability committee to generate appropriate review and approval of shelf life, retest dates and expiry dating of GMP materials.
  • Provide stability strategy and execution of future Phase 3 programs. And commercial product registration.
  • Author change controls associated with shelf life and retest date extensions.
  • Assess stability impact of manufacturing and/or formulation related process development work.
  • Support OOS/OOT deviation investigations and reports aberrant results to management.
  • Maintain the stability tracker and work with stability sites to ensure timely and accurate receipt of data.
  • Identify and communicate risks to shelf life and retest dates.  Participate in developing appropriate risk mitigation.
  • Review Quality Agreements with GMP vendors performing stability related activities (i.e. storage and testing).
  • Ensure stability data and reports are tracked through Avidity’s QMS.
  • Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

Qualifications

  • Minimum Bachelor’s degree in chemistry, biology, or pharmaceutical sciences.
  • Minimum of 8 years of pharmaceutical industry experience in a Quality Control/Quality Assurance or Stability Group.
  • Prior experience with stability program management with Biologics and/or oligonucleotides is preferred.
  • Experience with a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, and mass spectroscopy.
  • Experience with statistical software programs such as JMP.
  • Extensive knowledge of cGMP, ICH, FDA, EMA guidelines and requirements across development, registration, and validation.
  • Good working knowledge of GLP, LIMS, and GMP.
  • Proven track record in stability data trending, stability protocol and report and GxP risk assessment.
  • Proven track record of effective collaboration with external quality control and contract manufacturing organizations.
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment.
  • Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
  • Ability to multi-task, manage conflict, and work in a fast-paced environment.