The Perfect Addition to Our Team

You are a motivated, resourceful, and enthusiastic Drug Product Development & Manufacturing individual who is excited to support the company at a critical stage in its growth trajectory. You excel at formulation & drug product development (liquid and lyophilized), GMP manufacturing of drug products. If you can lead these activities with minimal supervision, yet thrive in a collaborative setting, this role is for you. At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Discovery, Process Chemistry, DS Development & Manufacturing, Analytical Development & Quality Control, Product Development, Clinical Operations, and CRO/CDMOs. Your ability and desire to thrive in a nimble, fast-paced results-driven environment will set you up for success.

The Opportunity

Lead the drug product development and manufacturing activities for Entrada’s novel pipeline programs. You will report to the Sr. Director of Drug Product Development & Manufacturing and will focus on developing liquid, lyophilized formulations, process development, and manufacturing activities for Oligopeptide and Biologics Drug Products.

Responsibilities

• Lead drug product formulation, characterization, process development, technology transfer, scale-up, and manufacturing activities for early to late-stage pipeline programs.
• Develop lyophilization cycles & processes to increase the stability of drug products.
• Focus on routes of degradation of drug products in liquid and lyophilized formulations under accelerated temperature, refrigerated storage conditions, and under different stresses in a variety of containers.
• Serve as a subject matter expert and provide direct oversight for drug product manufacturing activities at CDMOs including formulation, aseptic filling, visual inspection, manufacturing investigations, and change controls.
• Lead and manage the execution of various drug product-related studies including formulation robustness, filter validation, CCIT, extractables and leachable, in-use material compatibility, and shipping.
• Facilitate timely execution, disposition, and release of drug product batches through detailed technical review of master batch records, executed batch records, and other cGMP documentation.
• Support packaging & labeling activities of bulk drug products (if needed)
• Collaborate with QC stability lead in the design of phase-appropriate stability studies as per ICH guidelines.
• Responsible for driving execution of current production plan at CDMOs with long-term vision.
• Lead issue resolution, escalating appropriately to internal and/or joint governance if required.
• Develop, author, review, and approve technical study protocols, reports, and documentation related to manufacturing including quality documents.
• Autor/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, etc.).
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks, and investments required.
• Serve as drug product SME to support CMC and program teams in technical due diligence, CRO and CMO capability assessment, selection, and management for formulation and drug product development and manufacture.
• Provide input and participate in long-term strategic initiatives which enable sufficient growth to meet the program’s needs.

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 a scientific or engineering discipline with 10 years of related experience in the pharmaceutical industry.
• Demonstrated technical expertise in drug product manufacturing and development including formulation, process characterization (by QbD), tech transfer, scale-up, and clinical and commercial manufacturing.
• Experience with aseptic filling of liquid vials, pre-filled syringes, and lyophilized drug product vials.
• Significant experience in managing/collaborating with CRO, CMO, drug product primary packaging component suppliers, and production partners.
• Demonstrated ability to develop and maintain program timelines and budgets
• Working knowledge of 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.
• Ability to lead and ensure successful execution of DP development activities, including but not limited to formulation development/stability studies, in-use stability studies, extractable and leachable assessments, process development (scale-up) studies, and sterilizing filter sizing.
• Strong project management, interpersonal, communication, negotiation, and problem-solving skills preferable.
• Strong ability to communicate clearly and professionally both in writing and verbally.
• Ability to travel up to 20% (domestic and international).