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Senior Manager, Drug Substance Development
4 months ago
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 (EEVTM)-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 a motivated, resourceful, and enthusiastic Peptide and Oligonucleotide Manufacturing expert excited to support the company at a critical stage in its growth trajectory. If you have hands-on expertise on peptide and/or oligonucleotide process development, can oversee non-GMP/GMP manufacturing (for pre-IND through late-phase clinical studies) remotely and perform activities with minimal supervision in a collaborative matrix setting, this role is for you. At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Chemistry, Analytical, Drug Product, Pharmacology, Product Development, Quality, and CDMOs. Your ability and desire to thrive in a nimble, fast-paced results-driven environment will set you up for success.
The Opportunity
Senior Manager in drug substance development, and manufacturing for Entrada's novel pipeline programs.
Responsibilities
Identify and resolve manufacturing/testing issues and escalate appropriately to internal and/or joint governance if required.
Review master batch records, executed batch records, and other cGMP documentation to enable release and disposition of materials.
Partner closely with other internal functions including chemistry, quality control, quality assurance, DP formulation development, and regulatory affairs to ensure programs are effectively supported while maintaining high-quality standard.
Develop, author, review study protocols, reports, investigations, deviations, and documentation related to manufacturing including quality documents.
Author/review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization
Author/review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.).
Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
Manage material logistics and inventory (internally and externally).
Other tasks as assigned or as required for a given program.
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:
Demonstrated proficiency in process development, tech transfer, scale-up applicable for preclinical, clinical, and commercial supplies.
Demonstrated synthetic organic chemistry expertise through scientific publications and/or conference presentations.
Hands-on experience in SPPS and downstream operations is highly desirable. Experience in SPOS would be a plus.
Experience in working with CDMOs, raw material suppliers, testing partners, and other production partners.
Ability to interpret and relate Quality standards for implementation and review.
Strong project management, interpersonal, communication, and problem-solving skills preferable. Ability to communicate clearly and professionally both in writing and verbally.
Ability to travel up to 20% (domestic and international).
The position is hybrid. Expected onsite presence few days a week.
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.
