Associate Director, Analytical Development & QC

You are motivated, resourceful, and enthusiastic scientist and leader, excited to be a key contributor for the company at a critical stage in its growth trajectory. You enjoy developing and implementing new processes, connecting the dots for Analytical and Quality Control teams. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, to effectively build working relationships inside and outside of the company.

The individual will lead the development, implementation, and improvement of internal QC systems for internal teams and external partners. You will proactively manage QC gap analyses and help lead CDMO partnerships on analytical method transfer and phase-appropriate qualification and validation. You will not be siloed, but rather you will be expected to interact across different functional groups and partner collaboratively.

• Lead and manage, in partnership with internal cross-functional teams, QC quality events, such as change controls, deviations, adverse stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs.
• Partner with internal and external teams to meet timelines and company objectives, including, Non-clinical Development, Quality Assurance, Regulatory, and CRO/CDMOs.
• Proactively manage QC gap analyses and QC SOP authoring and revisions for continuous improvement.
• Oversee CDMO for analytical method transfer, phase-appropriate qualification/full validation, reference standard generation and qualification, stability program management and quality control related events.
• Support CDMO as a technical SME for drug intermediates, DS and DP QC testing activities, ensuring all activities are completed according to established timelines and quality standards.
• Support CDMO with management and communication of stability pulls and ensure stability testing occurs within specified testing windows to establish/extend DS and DP shelf life based on stability data.
• Coordinate with internal stakeholders to ensure uninterrupted clinical and commercial supplies.
• Oversee CDMO to manage reference standard and critical reagent programs, including qualification/requalification, inventory, and bridging activities.
• Partner with CMC technical SMEs, QA and Regulatory to prepare and review QC related sections of IND, IMPD, NDA/MAA and global regulatory submissions.
• Provide necessary support information for addressing information requests from regulatory agencies.

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:

• A Ph. D in Biochemistry, Analytical Chemistry or a related discipline with 6 + years (or 10 + years with a MS. Degree) of analytical and/or quality control experience in a Biotech or Pharmaceutical industry under GMP environment.
• Strong knowledge in QC principles, concepts, industry practices, and standards, including extensive knowledge of cGMP regulations and guidelines.
• Experience in characterization, method development, validation, and transfer of non-compendial and compendial analytical methods for oligonucleotides, especially PMO and PPMO, is highly desired.
• Strong knowledge and hands-on experience in regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.) with respect to the quality control for oligonucleotides.
• Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
• Excellent communication, both written and verbal, and interpersonal skills.
• Works independently with minimal supervision and is highly collaborative with other groups.
• Strong attention to detail and results driven in line with project and team objectives.
• Ability to handle multiple high priority tasks in parallel to meet organizational goals.
• This is a US based remote position, with preference given to local New England based candidates who can be in office 1 day per week. This role will require a minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-JF1 #LI-Remote 

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. #LI-JF1 #LI-Onsite 

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. If you find yourself working from our office in Boston’s Seaport District, this puts you steps away from some of the best the city has to offer.

“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.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $169,000 - $194,000. 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.