Associate Director, Drug Substance Development & Manufacturing

Entrada Therapeutics•Boston, MA

7h•$172,000 - $202,000•Remote

About The Position

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- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has 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. You are a motivated, resourceful, and enthusiastic Drug Substance Development & Manufacturing expert excited to support the company at a critical stage in its growth trajectory. You excel at peptide and/or oligonucleotide late-stage process development, GMP manufacturing and supply chain of drug substances. You thrive when performing these activities with minimal supervision in a collaborative matrix environment. At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Chemistry, Analytical, Drug Product, Quality, and CDMOs. Your ability and desire to thrive in a nimble, fast-paced results-driven environment will set you up for success. The Associate Director of Drug Substance Development and Manufacturing will lead and manage late-stage drug substance development for Entrada’s novel pipeline programs. This role will be instrumental in supporting development activities for clinical and commercial batches and ensuring validation parameters for manufacturing batches.

Requirements

Master’s or suitable advanced degree in organic chemistry or other scientific or engineering discipline with 8+ years of related experience in pharmaceutical industry.
Demonstrated proficiency in process development, tech transfer, scale-up, GMP manufacturing DS for clinical, and commercial supplies.
Proficient in managing activities and resolving manufacturing challenges at CDMOs during routine cGMP manufacturing and process validations.
Experienced in onboarding/managing/collaborating with CDMOs, raw material suppliers, testing partners, and other production partners.
Demonstrated ability to develop and maintain production timelines and budgets.
Up-to-date with industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA and EMA).
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).

Nice To Haves

Hands-on experience in SPPS/SPOS, downstream purification and lyophilization is highly preferred.

Responsibilities

Facilitate timely execution, disposition, and release of intermediate/drug substance batches through detailed technical review of master batch records, executed batch records and other cGMP documentation.
Partner with internal and external Quality Assurance, Quality Control and Technical Operations teams to execute late-stage development activities such as Process Characterization and Process Performance Qualifications.
Act as a person-in-plant for smooth execution of critical manufacturing activities for clinical and commercial batches.
Conduct risk assessments and develop mitigation strategies for manufacturing-related issues.
Identify and resolve manufacturing issues and escalate appropriately to internal and/or joint governance if required.
Implement and manage the Continuous Process Verification (CPV) program to ensure manufacturing process remain in a constant state of control and meet validated parameters.
Author/review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization
Work closely with other internal functions including chemistry, analytical, quality control, quality assurance, DP, and regulatory affairs to ensure programs are effectively supported and high-quality standard maintained.
Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
Author/review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.).
Other tasks as assigned or as required for a given program.