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Associate Director Analytical Development Jobs in Pennsylvania

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Associate Director Analytical Development information

What does an associate director analytical development do?

An Associate Director of Analytical Development is responsible for overseeing the development, validation, and implementation of analytical methods used to test pharmaceutical products or biologics. They lead teams of scientists, manage laboratory operations, and ensure compliance with regulatory requirements. Their role is crucial in supporting product development, quality control, and ensuring the safety and efficacy of drugs throughout the development process.

What are the key skills and qualifications needed to thrive as an associate director analytical development, and why are they important?

To thrive as an Associate Director Analytical Development, you need a strong background in analytical chemistry, method development, and pharmaceutical regulations, typically supported by an advanced degree in a relevant scientific field. Familiarity with analytical instruments such as HPLC, GC, and mass spectrometry, as well as experience with regulatory submission systems and quality management tools, is crucial. Leadership, strategic thinking, and effective communication are vital soft skills for managing teams and collaborating cross-functionally. These skills ensure robust analytical support for drug development, regulatory compliance, and successful project delivery.

What are some common challenges faced by an associate director analytical development, and how can they be addressed?

An Associate Director of Analytical Development often encounters challenges such as managing multiple complex projects simultaneously, ensuring regulatory compliance, and fostering effective collaboration between cross-functional teams. Balancing the need for robust scientific methods with tight project timelines requires strong organizational and leadership skills. To address these challenges, it is essential to establish clear communication channels, prioritize tasks based on risk and impact, and stay updated on evolving regulatory guidelines. Actively mentoring team members and promoting a culture of continuous improvement can also help streamline workflows and enhance overall team performance.

What is the difference between Associate Director Analytical Development vs Senior Scientist Analytical Development?

AspectAssociate Director Analytical DevelopmentSenior Scientist Analytical Development
ResponsibilitiesOversees analytical development teams, manages project strategies, and ensures regulatory compliance.Conducts experimental work, develops assays, and supports project execution under supervision.
Required CredentialsBachelor's or Master's in Chemistry, Biochemistry, or related; 8+ years experience; leadership skills.Bachelor's or Master's in relevant field; 5+ years experience; technical expertise.
Work EnvironmentLeads teams in R&D or manufacturing settings, often in biotech or pharma companies.Performs laboratory research, assay development, and experimental analysis.

The main difference is that the Associate Director Analytical Development holds leadership and strategic responsibilities, overseeing teams and projects, while the Senior Scientist Analytical Development focuses on hands-on experimental work and technical development. Both roles require strong scientific credentials and industry experience, but the associate director position involves more managerial duties and project oversight.

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What job categories do people searching Associate Director Analytical Development jobs in Pennsylvania look for?

The top searched job categories for Associate Director Analytical Development jobs in Pennsylvania are:

What cities in Pennsylvania are hiring for Associate Director Analytical Development jobs?

Cities in Pennsylvania with the most Associate Director Analytical Development job openings:

Associate Director Analytical Development jobs near you
Infographic showing various Associate Director Analytical Development job openings in Pennsylvania as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 11% Part Time, and 2% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution.

Associate Scientist, Analytical Development

Cabaletta Bio Inc.

Philadelphia, PA • On-site

Full-time

PTO

Posted 27 days ago

Job description

Associate Scientist, Analytical Development - On-site, Philadelphia, PA
Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.
Uniquely Differentiated. Rapid. Elegant.
At Cabaletta, we are driven by the shared mission of developing cures, where a patients' own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.
We're proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®
Position Summary
Reporting to Director, Analytical Development, this experienced and motivated Associate Scientist will join Analytical Development Team, participating in a variety of analytical activities involved in lifecycle method management - method development and qualification, analytical testing support for projects at Process Development and CDMOs, CDMO testing oversight (assay performance trending, troubleshooting/root cause analysis) for pre-clinical and clinical programs.
The successful candidate has opportunities to collaborate closely with CMC, Quality & Compliance, Supply Chain, and external partners.
Responsibilities
  • Participate in the development, optimization, and qualification/validation of analytical methods, as required to evaluate safety, purity, identity, potency of lentiviral vectors, cell therapy product and other advanced modalities, in compliance with relevant regulatory guidelines
  • Perform analytical testing, supporting method development and qualification activities.
  • Participate in technical oversight and serve as subject matter expert (SME) to CDMOs and external laboratories.
  • Assist monitoring/trending of assay performance, investigation of assay deviations, out-of-specification, out-of-trend and out-of-expectation results at Analytical Development and external partners.
  • Provide analytical expertise to Process Development, Manufacturing Sciences and Technology (MSAT), Quality & Compliance, and Quality Control
  • Author and review method protocols, reports, and supporting documentation, ensuring compliance with GMP, GDP, and applicable regulatory requirements.
  • Present in technical meetings and drive resolution of analytical-related issues.

Qualifications
  • Bachelor's or master's degree in biology or closely related discipline with 2-4 years of experience.
  • Proficient in aseptic techniques for cell culture and cell-based assays.
  • Strong experience in analytic techniques, including flow cytometry, qPCR/dPCR, ELISA, HPLC etc.
  • Demonstrated experience with analytical method qualification and validation.
  • Experience working with CDMOs and contract testing laboratories in biologics, cell and gene therapy fields.
  • Familiar with GMP compliance.
  • Demonstrated scientific problem-solving, critical-thinking, and communication/ interpersonal skills, with attention to detail and strong organizational skills, and ability to manage multiple priorities in a fast-paced environment.

Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.
Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.
And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.
#LI-ONSITE

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