Manager/Senior Manager of Analytical Chemistry

Location
Waltham, Massachusetts (US)
Salary
$120,000-$150,000
Posted
Sep 08, 2021
Required Education
Bachelors Degree
Position Type
Full time

At Viridian Therapeutics (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

Reporting to the Director of Analytical Chemistry, the Manager/Senior Manager of Analytical Chemistry is responsible for the management of analytical studies to advance drug substance and product through development and commercialization. The incumbent will work collaboratively with internal stakeholders to ensure accurate tracking, analysis and reporting of stability protocol and study results.

Primary Responsibilities:

  • Develop a system to track formal and informal stability and stress studies for Viridian developmental projects.
  • Develop and maintain the system to support entire life cycle of drug substance and drug product from development to commercialization.
  • Prepare and/or review stability protocols, reports and technical development reports.
  • Prepare and/or review qualification/validation protocols, reports and analytical methods for DS and DP at phase appropriate levels.
  • Review raw data and perform statistical analysis of the data to support data-driven decision making.
  • May lead analytical aspects of CMC projects
  • Applies the principles and techniques of analytical chemistry to solving manufacturing and testing challenges
  • Communicate to directors any potential deviation including OOS or OOT results from CRO/CMO.
  • Interpret and present data to cross functional teams in a comprehensive format as required.
  • Provide technical guidance for analytical methods and transferred within an external network, ensuring methods are technically sound and well developed.
  • Manage CRO/CMO for analytical activities for drug substance and (or) product method development and validation.
  • Assist in the preparation of regulatory submissions
  • Provide support and contribute to other analytical activities as necessary

Requirements

  • BS in Analytical Chemistry or related discipline with 7+ years’ experience in pharmaceutical/ biotechnology industry or MS with 5+ years of experience in the pharmaceutical/ biotechnology industry.
  • 3 years’ experience in monoclonal antibodies analytical method development, qualification and validation by ICH guidelines.
  • A minimum of 3 years’ experience managing ICH stability programs.
  • Thorough knowledge of cGMP’s as they relate to pharmaceutical development.
  • Knowledge of US and international regulatory requirements (ICH Quality Guidance)
  • Can do attitude and executing the ever-changing tasks needed in a small company environment.
  • Experience working with and managing third party vendors.
  • Strong oral/ written communication skills. Excellent interpersonal/ organizational skills and the ability to multi-task.
  • Ability to travel 10 - 20% domestic and internationally.

Compensation: The salary range for this position is $120,000 - $150,000 and commensurate with experience. 

Viridian offers a comprehensive benefits package including:

  • Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents.
  • Short- and long-term disability coverage
  • Group term life insurance
  • Medical and Dependent Care FSA
  • 401(k) Company match
  • Employee Stock Purchase Plan

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws.