Associate Director, Analytical Development and QC job at Entrada Therapeutics

Remote; Deutschland; Remote; USD 169.000 - 194.000; Vollzeit

Zusammenfassung

A clinical-stage biopharmaceutical company is seeking an Associate Director for Analytical Development & QC. This role involves leading QC systems, managing partnerships, and ensuring compliance with regulatory standards. Ideal candidates will have a Ph.D. and extensive experience in biotech environments. The position emphasizes a collaborative approach and strong analytical skills, offering a competitive salary and comprehensive benefits.

Leistungen

Unlimited or Flexible PTO

Health Insurance

Education Assistance

Paid Parental Leave

Qualifikationen

• 6+ years of analytical and quality control experience in a Biotech or Pharmaceutical industry.
• Strong knowledge in QC principles and regulatory requirements.
• Experience in method development and validation for oligonucleotides.

Aufgaben

• Lead QC quality events and investigations.
• Oversee CDMO for method transfers and validations.
• Partner with internal and external teams to meet objectives.

Kenntnisse

Analytical skills

Communication skills

Collaboration

Problem-solving

Ausbildung

Ph. D in Biochemistry or Analytical Chemistry

MS Degree in related discipline

Tools

Knowledge of cGMP regulations

Familiarity with FDA/EMA/USP standards

Jobbeschreibung

• Associate Director, Analytical Development and QC

Associate Director, Analytical Development and QC

Senior Level Manager (Director, Dept Head, VP, General Manager, C-level)

Unlimited or Flexible PTO, Health Insurance, Dental Insurance, Vision Insurance, Life Insurance, Parental Leave, Retirement Savings, Education Assistance, Disability, Paid Time Off

About the Role

Title: Associate Director, Analytical Development & QC

Job Description:

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular 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 lead 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 develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready 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 Addition to Our Team

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 Opportunity

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.

Responsibilities

• 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.
• 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.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives ourbehavior:

• Humanity- We genuinely care about patients and about one another.
• Tenacity- We are relentless and persistent in the pursuit of developing therapiesfor 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

What We Offer: Meaningful Work, Fair Rewards, and Real Support

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.

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and 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. For the protection of all parties involved in the recruiting process, 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 sent 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.