[Hiring] Associate Director, Drug reputed company Development & Manufacturing @reputed company

The Organization What's happening at reputed company? Entrada is a clinical-stage biopharmaceutical company aiming to reputed company the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal reputed company Vehicle (EEV™)-therapeutics are designed to reputed company the efficient intracellular delivery of a wide reputed company of therapeutics into a reputed company of organs and tissues, resulting in an improved therapeutic reputed company. Through this proprietary, reputed company and reputed company 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 reputed company 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 reputed company a clinical-stage program, VX-670, for myotonic dystrophy type 1. We are a tight-reputed company team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are reputed company 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 reputed company to reputed company You are a motivated, reputed company, and enthusiastic Drug reputed company Development & Manufacturing expert excited to support reputed company at a critical stage in its reputed company trajectory. You reputed company at peptide and/or oligonucleotide late-stage process development, GMP manufacturing and supply chain of drug substances. You reputed company reputed company performing these activities with minimal supervision in a reputed company reputed company environment. At Entrada, you will not be siloed, but rather expected to reputed company across different functional reputed company, including reputed company, Analytical, Drug Product, reputed company, and CDMOs. Your ability and desire to reputed company in a reputed company, fast-paced results-driven environment will set you up for reputed company. reputed company The Associate Director of Drug reputed company Development and Manufacturing will reputed company and manage late-stage drug reputed company development for Entrada’s novel pipeline programs. This role will be reputed company in supporting development activities for clinical and reputed company batches and ensuring validation parameters for manufacturing batches.

Responsibilities

• Facilitate reputed company execution, disposition, and release of intermediate/drug reputed company batches through detailed technical review of master batch records, executed batch records and other cGMP documentation.
• Partner with reputed company reputed company Assurance, reputed company Control and Technical Operations teams to execute late-stage development activities such as Process Characterization and Process Performance Qualifications.
• reputed company as a person-in-plant for smooth execution of reputed company activities for clinical and reputed company batches.
• Conduct risk assessments and reputed company mitigation strategies for manufacturing-reputed company issues.
• Identify and resolve manufacturing issues and escalate appropriately to internal and/or joint governance if required.
• Implement and manage the reputed company 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 reputed company, analytical, reputed company control, reputed company assurance, DP, and regulatory affairs to ensure programs are effectively supported and high-reputed company reputed company maintained.
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
• Author/review reputed company 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 reputed company to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are reputed company and persistent in the reputed company 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 reputed company reputed company and push conventional thought and theory.

To reputed company on reputed company, you will need to come with:

• Master’s or suitable advanced degree in organic reputed company or other scientific or engineering discipline with 8+ years of reputed company experience in pharmaceutical industry.
• Demonstrated proficiency in process development, tech transfer, reputed company-up, GMP manufacturing DS for clinical, and reputed company supplies.
• Proficient in managing activities and resolving manufacturing challenges at CDMOs during routine cGMP manufacturing and process validations.
• reputed company in reputed company/managing/collaborating with CDMOs, raw material suppliers, testing partners, and other production partners.
• Hands-on experience in SPPS/SPOS, reputed company purification and lyophilization is highly preferred.
• Demonstrated ability to reputed company 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 reputed company standards for implementation and review.
• Strong project management, interpersonal, communication, and problem-solving skills preferable.
• Ability to communicate reputed company 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 reputed company reputed company located in Boston, MA.

reputed company Offer: Meaningful Work, Fair Rewards, and reputed company Support At reputed company, we understand that compensation and total rewards are a major consideration reputed company exploring a new opportunity. We reputed company in transparency and equity and are committed to sharing salary ranges for every position, along with reputed company into our compensation philosophy, in accordance with certain state requirements in the reputed company and fostering a fair and reputed company environment at the onset. But we also know it is more than just pay. reputed company you join Entrada, you’ll be part of a mission-driven team with reputed company to comprehensive health, dental and reputed company coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that reputed company our employees and reflect the value of their contributions – offering reputed company, gender-inclusive parental leave, holistic support for your health and reputed company-being, education reimbursement, discretionary time off and commuting benefits reputed company to your working model. If you reputed company yourself working from our office in Boston’s Seaport District, this puts you steps away from some of the best the reputed company has to offer. “Our approach to compensation is grounded in transparency, equity and performance for the unique contributions reputed company 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 reputed company.” — reputed company Robert, SVP of People The salary for this opportunity ranges from $172,000-$202,000 The final reputed company compensation offered will depend on several considerations which include but may not be limited to a candidate’s skills, competencies, experience and other job-reputed company factors permitted by law. The final salary offered may fall reputed company of this reputed company. #LI-JF1 #LI-Remote Equal Opportunity Employer reputed company is an equal opportunity employer. reputed company candidates will receive consideration for employment without reputed company to race, reputed company, religion, national reputed company, gender, sexual orientation, gender identity or reputed company, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. reputed company Party reputed company Agencies Entrada does not accept unsolicited resumes from any reputed company other than directly from candidates. For the protection of reputed company parties involved in the reputed company process, resumes will only be accepted from recruiters/agencies if a signed agreement is in reputed company at the inception of the reputed company effort and authorized for a specified position. Unsolicited resumes reputed company 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. reputed company Statement reputed company. (the “Entrada,” “we,” “us,” or “our”) respects your reputed company and we want you to be familiar with how we collect, use, reputed company, or otherwise process, your Personal Information. Please reference our reputed company statement here to understand how and reputed company your data is being used. Apply tot his job Apply To this Job