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

• Provide technical support on process development for intermediates (peptide and oligonucleotide) and drug substance at CDMOs applicable for early- and late-stage programs.
• 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:

• Requires an advanced degree in organic chemistry or other scientific or engineering discipline with 5 years of related experience in pharmaceutical industry.
• 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.