Senior Specialist, Quality GMP (Contract)

The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable.

We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

The Perfect Addition to Our Team You are analytical and detail oriented.

You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You are detail-oriented and able to review and analyze quality issues quickly in order to provide robust and timely solutions. You are dependable and accountable for your work.

You are an excellent team player and relationship builder. The Opportunity The Sr. QA Specialist will be responsible for supporting GMP QA processes, including master and executed batch record review and disposition of drug substances and drug products (including package and labeling). The positions is also responsible for owning and supporting deviations, change control, and CAPA‘s.

This role will contribute to development of the internal Quality Management System (QMS) and support other internal QA functions including training, documentatio0n, This role is based in Boston, MA and reports directly to the Director of GMP QA. Responsibilities Review and approve Master and Executed Batch Records. Review in-process, release, and stability data.

Disposition lots from intermediates through finished drug product. Supports internal and external deviations, change control, and CAPA. Supports Vendor Management Program, including management of vendor audit activities and the Approved Supplier List.

Writes and implements changes to Standard Operating Procedures. Coordinates and reviews change control activities to drive change control records to closure. Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records.

Performs the appropriate QA review/approval of SOPs, SOP-related documents, and Policies. Leads and supports understanding and adoption of risk-based approaches and decision making. Serve as Quality resource, representing QA on teams in support of assignments.

Interacts on cross-functional teams including manufacturing and QC. Supports all GxP functions as needed. The Necessities At Entrada, our passion for science, our devotion to patients and our values drives our behavior: Humanity

• We genuinely care about patients and about one another. Tenacity

• We are relentless and persistent in the pursuit of developing therapies for patients. Creativity

• We are creative problem solvers. Collaboration

• We are more than the sum of our parts. Curiosity

• We have a growth mindset and push conventional thought and theory. To thrive on our team, you will need to come with: 5 years of experience in chemistry, biology, or related scientific or engineering field.
  
  Experience supporting GMP and CMC functions from QA perspective is required. Strong attention to detail and ability to communicate and collaborate with stakeholders outside of Quality. Authoring and reviewing SOP’s.
  
  Based in the Boston area with ability to come into the office 3 days. Method validation, stability, and other QC support functions are nice to have. LI-DS1 The Perks By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance.
  
  We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.
  
  Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. Third Party Staffing Agencies Entrada does not accept unsolicited resumes from any source other than directly from candidates.
  
  For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes. Privacy Statement Entrada Therapeutics, Inc. (the “ Entrada ,” “ we, ” “ us, ” or “ our ”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.