Senior Director, Technical Product - Remote

Overview

The Senior Director, Technical Product Lead (TPL) is a senior leader within the Technical Development Department responsible for representing the CMC matrix on multiple program teams in our expanding pipeline and sitting on Program Teams as the Tech Ops representative. This TPL will also be responsible for establishing the Technical Development Strategy team, which will manage the Tech Ops Leadership for all programs in the pipeline and standardize TPL ways of working.

In Short

• Head and build out the Technical Development Strategy Function
• Cross-functional Tech Ops Lead member of Program Core Team for late-phase and early-phase programs
• Responsible for Tech Ops Strategy for program and represents Tech Ops at the Program level
• Cross-functional review of all Tech Ops documents including IND/IMPD, RTQs, and other regulatory documents
• Representative in Regulatory Interactions
• Scale up and tech transfer protocols
• Close interactions with clinical supply and clinical/commercial manufacturing planning
• Presenting Program Stage Gate at the Steering Committees
• Author and review relevant sections of Regulatory filings
• Identify and communicate risks to clinical programs and commercial supply chain

Requirements

• Minimum Bachelor’s degree in chemistry, chemical engineering, pharmaceutical science, or related field required
• Minimum of 12 years of pharmaceutical industry experience in bioprocess, or oligonucleotide PD and Manufacturing
• Minimum of 6 years of pharmaceutical industry experience in a CMC leadership role for a biologics, or oligonucleotide mid to late-phase program
• Prior experience in clinical Phase 3/commercial readiness process development and manufacturing
• Experience working with third-party CDMOs
• Prior IND and BLA/NDA filing experience
• Knowledge of cGMP, ICH, FDA, and EMA guidelines
• Proven track record of effective internal and external collaboration
• Excellent communication and interpersonal skills
• Ability to multi-task, manage conflict, and work in a fast-paced environment

Benefits

• The base salary range for this role is $261,250 - $288,000.
• Avidity offers competitive compensation and benefits, including annual bonuses, stock options, and RSUs.
• 401(k) with employer match.
• Comprehensive wellness program including medical, dental, vision, and LTD.
• Four weeks of time off.
• Commitment to learning and development opportunities.