The Perfect Addition to Our Team
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 Opportunity
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.
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.
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:
• 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. • Hands-on experience in SPPS/SPOS, downstream purification and lyophilization is highly preferred. • 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).
This is a US-based remote position with preference given to local New England-based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.
What We Offer
At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.
But we also know it is more than just pay. When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model.
"Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward - and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward."
The salary for this opportunity ranges from $172,000-$202,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote