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Executive Director/Vice President, Technical Development and Operations

Employer
Avidity Biosciences
Location
San Diego, California
Start date
Aug 1, 2022

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Discipline
Manufacturing & Production, Operations
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Who are we: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

Executive Director/Vice President, Technical Development and Operations will join the executive management team and play a key role in leading the manufacturing of antibody oligonucleotide conjugates from Development candidate selection through Phase 3 transition and implementing cGMP operating principles including regulatory and quality assurance (QA).  By leading an innovative, collaborative fast-paced group, you will be responsible for creating the vision, inspiring teams, and delivering on immediate and long-term goals for the department and organization. Must be a dynamic leader with outstanding communication, strategic and collaboration skills, ability to influence and a sense of urgency to deliver high-quality therapeutics to people with rare diseases.

Responsibilities include:
  • Lead and manage the drug substance and drug product development activities from development candidate, CTA/IND submission through the transition to Phase 3 at CMOs. Ensure that manufacturing meets all necessary technical specifications, timelines, budgets, and regulatory requirements.
  • Lead external cell line development, optimization of antibody production including both upstream and downstream manufacturing.
  • Collaboratively work with team members and functions in selection and management of CMOs for antibody production, oligonucleotide manufacturing, conjugation, formulation development, drug substance and drug product including writing RFPs, contract negotiation, and management of the projects once approved.
  • Provide technical leadership to ensure that technical development and production will meet IND through Phase 2 global clinical supply needs and all appropriate global regulatory requirements.
  • Provide support to regulatory interactions on CMC related topics. Manage writing and review of technical CMC documents for regulatory filings (CTAs, IND, BLAs, MAA) and participating in cross-functional, interdisciplinary product development teams.
  • Responsible for the QA oversight of day-to-day GMP Operations at the CMOs for entry into the clinic through Phase 2.
  • Ensure all US, EU, and other suppliers are compliant with local and international regulatory and import/export requirements by working closely regulatory leadership.
  • Schedule, plan and prepare CMO for audits; along with internal processes, submission documents etc. in accordance with the audit plan or as requested.
  • Assist with GMP inspection readiness activities for regulatory authority inspections and coordinate tracking of document requests, responses, and supporting documentation during inspections.
  • Provide support for supply planning, procurement and forecasting of demand, to guarantee resource requirements are met.
  • Manage the supply of drug product for Phase 1 through entry into Phase 3 through accurate inventory management.
  • Responsible for risk reduction measures through effective risk mitigation programs that focus on appropriate second source strategies, increasing capacities of vendors and shortening supply chain cycle times.
  • Maintain working knowledge of current FDA, EU, and other global regulation and guidance governing Good Manufacturing Practice (GMP), Pharmacovigilance (PV) and Good Laboratory Practice (GLP) activities.

 

Desired Knowledge and Abilities:
  • Experience and ability to lead an innovative, collaborative, dynamic team.
  • Excellent communication (verbal and written) and interpersonal skills with the ability to clearly communicate and influence at all levels within the organization.
  • Ability to think strategically and translate strategies into actionable plans.
  • Takes responsibility, drives for results and achieves expected outcome.
  • Experience compiling and writing technical packages for regulatory filings including a working knowledge of cGMP manufacturing and all applicable FDA and EMA regulations.
  • Experience with BLA filings is strongly preferred
  • Demonstrated ability to manage multiple development projects and CMOs simultaneously.
  • Experience generating and overseeing development plans for drug product from preclinical through transition to Phase 3 clinical development.
  • Demonstrate excellent leadership skills.
  • Demonstrate strong organizational skills, including the ability to prioritize workload.
  • Outstanding people management, and effective talent development.
  • Leadership experience in a small company environment is desirable.
  • Ability to work well in a deadline-driven environment.

 Education and Experience:

 PhD equivalent experience required

  • Minimum 10 years in a management role within CMC
  • Minimum 15 years of experience in pharmaceutical / biotech

Company

Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.

Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.

We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.

 

Find Us
Website
Phone
858-401-7900
Location
10975 N. Torrey Pines Road
Suite 150
La Jolla
California
92037
United States
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