Senior Scientist II, Drug Substance Manufacturing & Development

Overview

Senior Scientist II, Drug Substance Manufacturing & Development role at Entrada Therapeutics. The Senior Scientist II will support and lead late-stage drug substance development and manufacturing for Entrada’s novel pipeline programs. This individual will provide oversight for non-GMP and GMP Drug Substance manufacturing (for pre-IND through late-phase clinical studies) remotely and perform activities with minimal supervision in a collaborative matrix setting. You will interact across Chemistry, Analytical Development, Drug Product Development, Pharmacology, Product Development, Quality, and external CDMO partners. The ideal candidate thrives in a fast-paced, cross-functional environment and is committed to delivering high-quality results.

The organization is focused on endosomal escape vehicle (EEV) therapeutics designed to enable efficient intracellular delivery of therapeutics to various organs and tissues, with a portfolio including RNA- and protein-based programs for neuromuscular and ocular diseases, and partnerships on clinical-stage programs such as VX-670 for myotonic dystrophy type 1. This is a remote-based position with some on-site requirements at the Entrada Therapeutics Headquarters in Boston, MA.

Responsibilities

• Provide technical support on process development for intermediates (peptide and oligonucleotide) and drug substance at CDMOs applicable for 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 standards.
• Conduct process risk assessment using FMEA or DoE for oligos/peptides/DSs.
• Develop, author, and review protocols, reports, investigations, deviations, and documentation related to manufacturing, including quality documents.
• Author and/or review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization.
• Author and/or review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.) and support health authority questions as needed.
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments as required.
• Manage material logistics and inventory (internally and externally).

Qualifications / The Necessities

• A Ph.D. in Organic Chemistry or related life sciences discipline, with 4+ years of relevant experience across drug substance manufacturing in the biotechnology or pharmaceutical industry; MS with 9+ years of relevant experience may also be considered; BS with applicable experience will be considered.
• Demonstrated proficiency in process development, tech transfer, and scale-up applicable for preclinical, clinical, and commercial drug development.
• Deep experience leading CDMO and vendor oversight.
• Experience in conducting process risk assessments by FMEA and/or DoE is desirable.
• Hands-on experience in SPOS and downstream operations is highly desirable; SPPS experience preferred.
• Ability to interpret and relate quality standards for implementation and review.
• Strong project management, interpersonal, communication, and problem-solving skills.
• Ability to communicate clearly and professionally both verbally and in writing.
• Ability to travel up to 20%, both domestically and internationally as required.
• This position is a US remote-based position requiring a minimum of 1 day per week onsite at the Entrada Therapeutics Headquarters in Boston, MA.

What We Offer

Meaningful work, fair rewards, and real support. Entrada Therapeutics shares salary ranges and compensation philosophy in accordance with state requirements, and offers comprehensive health, dental, and vision coverage; life and disability insurance; 401(k) with match; paid parental leave; education reimbursement; discretionary time off; and commuting benefits. On-site employees in Boston’s Seaport District are based close to local amenities.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, meaningful work deserves meaningful reward.”

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will be considered without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. Resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes do not create a relationship or obligation to pay fees.

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