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Senior Quality Control Specialist (Stability)

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role

Reporting to the Quality Control Manager, the Senior QC Specialist will serve as the Stability Program subject matter expert and be responsible for the management of the Vedanta Stability program, supporting raw materials, cell banks, drug substances, and drug products used in the manufacturing of GMP products.  The Senior QC Specialist will be responsible for trending and maintaining product stability data, authoring stability reports, and regulatory submission documentation.

Here’s What You’ll Do:

  • Manage Vedanta’s stability program by authoring procedures and performing tasks in accordance with ICH, FDA, and EMA guidelines and requirements
  • Represent Vedanta Quality Control as subject matter expert of the stability program
  • Manage stability data for multiple clinical stage products
  • Manage stability testing timelines and activities performed at Vedanta’s contract testing facilities 
  • Draft and revise stability reports and regulatory submissions
  • Participate in OOS investigations, specification and shelf-life establishment, corrective and preventative actions, and change controls with specific emphasis on utilization of product and compliance knowledge. 
  • Participate in projects for continuous improvement initiatives within QC department
  • Assist in preparation and review of quality records including standard operation procedures (SOPs)

Requirements:

  • BSc. in a life science with 5+ years in a GMP Quality Control environment with focus on stability testing and data trending
  • Previous experience in establishment/management of GMP stability programs a plus
  • Strong knowledge of USP, EU, ISO compliance
  • Excellent written and oral communication skills
  • Experience working in a higher compliance environment is an asset
  • Experience working with CTOs, vendors and relationship management
  • Strong laboratory and organizational skills, attention to detail, flexibility, and the ability to work within a team environment
  • Proficient in Outlook, MS Word, Excel, and lab-based data management systems

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

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