Director / Sr. Director Quality Assurance (USA)

 

Reports To:  Senior Vice President Pharmaceutical R&D and Operations

Duties and Responsibilities:   

This position will be responsible for leadership of all aspects of Quality Assurance at Selecta Biosciences. This includes ensuring compliance with applicable regulations from FDA, EMA, and ICH including GMP, GCP and GLP standards for preclinical and clinical development programs. Selecta has a Synthetic Vaccine Particle (SVP™) technology that utilizes synthetic nanoparticles to elicit the desired and optimal immune response. The SVPs are biodegradable polymer based nanoparticles with multiple active components that are required for a strong and robust immune response. Selecta works with contract manufacturers for raw materials and finished drug product manufacture and uses a combination of contract labs and internal GMP testing capabilities. This position will be responsible for managing the Quality relationship with outside contractors, have QA approval responsibilities, and establish internal Quality standards. The successful candidate will also build on the existing Selecta Quality System and expand it as needed to meet the expanding needs of Selecta. It is expected that this position will successfully work cross-functionally to integrate the appropriate aspects of Quality Assurance across all functions and levels of the company. The successful candidate will also be able to work with people with diverse backgrounds and abilities for the purpose of solving problems for the development of products.  Excellent written and oral communication skills are required as is demonstrated leadership ability.

Education and  Requirements:           

Bachelors Degree with a minimum of 10 years experience in pharmaceutical Quality Assurance, including significant leadership experience.  Experience with sterile products desirable and experience with particulate and/or polymeric systems a plus. Additional requirements include:

• Experience in developing Quality Systems in compliance with FDA/EMA/ICH requirements
• Experience in developing, writing, reviewing and approving SOP's
• Experience in conducting internal and external audits for GMP, GLP, and GCP compliance as applicable
• Experience with leading FDA and other agency regulatory inspections a plus
• Experience in the drug/biologic/vaccine development process including preclinical and clinical development
• Experience in contribution to and review of regulatory submission documents
• Excellent written and verbal communication skills and ability to work effectively in cross functional teams
• Demonstrated leadership skills

About Selecta Biosciences:

At Selecta Biosciences, we are developing an entirely new class of targeted vaccines that induces an antigen-specific immune activation or an antigen-specific immune tolerance for therapeutic and prophylactic applications.

Our proprietary technology platform is based on innovations in nanotechnology and immunology discovered at MIT and Harvard Medical School. Selecta's platform has the capability of creating robust immune responses to a wide range of antigens while limiting adverse events.

We are focusing on building a pipeline with a broad range of product candidates in oncology, neuroscience, infectious diseases, autoimmune diseases, and allergies.

Selecta has assembled an experienced leadership team with extensive experience in drug delivery, immunology and product development and is continuing to build a top-tier, collaborative, and creative team to solve challenging chemical, biological, and engineering problems.  The ideal candidate will thrive in a fast paced, science driven, and exciting work environment focused on applying our product platform technology across multiple R&D programs, with the goal of greatly improving the lives of patients. 

Please email your Resume/CV to careers@selectabio.com.

NO PHONE CALLS OR AGENCIES PLEASE. 

Selecta Biosciences, Inc. is an equal opportunity employer offering a competitive salary and benefits package including 401(k) retirement plan, incentive stock options, and professional development.

Please refer to Job Code QA1 when corresponding about this position.