Sr. Director/Executive Director, Analytical Development needed in United States

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Sr. Director/Executive Director, Analytical Development

Company: WORKHUB AGENCY

Job Location: United States

Job Type: FULL_TIME - (ON_SITE)

Job Salary: 0 USD per month.

Date Posted: April 16, 2025

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Job Description

About JobgetherJobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.One of our companies is currently looking for a Sr. Director/Executive Director, Analytical Development in the United States.In this role, you will oversee the analytical development and commercial quality control functions for late-stage small molecule programs. You will play a key role in regulatory strategy and execution, ensuring robust analytical methods and high-quality data packages to support regulatory submissions. This position will collaborate cross-functionally with formulation, manufacturing, and quality teams, and interface closely with external partners. It is ideal for a scientific leader with deep technical expertise, a hands-on mindset, and a passion for impactful drug development. The environment is fast-paced, virtual, and mission-driven, requiring adaptability and a solutions-focused approach.Accountabilities:Lead analytical strategy across multiple late-stage development programsManage internal teams and external partners (CROs/CDMOs) to ensure project timelines and quality expectations are metAuthor and review analytical sections for global regulatory submissions (IND, NDA, MAA, etc.)Oversee analytical method development, validation, transfer, and troubleshootingCollaborate with formulation, manufacturing, and QA teams to drive CMC developmentEnsure compliance with GMP standards and global regulatory guidelines (ICH, FDA, EMA)Provide input on overall control strategy for drug substance and drug product Ph.D./M.S. in Chemistry, Analytical Chemistry, or related field (B.S. with 15+ years experience also considered)10+ years of experience in analytical development within the pharmaceutical industryProven leadership and team management experience in both internal and external settingsDeep knowledge of analytical techniques (HPLC, GC/MS, LC/MS, XRPD, DSC, dissolution, KF, etc.)Hands-on experience with regulatory submissions, including Module 3 of CTDFamiliarity with GMP regulations and expectations for late-stage developmentExcellent communication and problem-solving skills; ability to lead in a virtual environment Competitive compensation package including base salary, bonus, and equityComprehensive health, dental, and retirement benefitsFlexible Paid Time Off (PTO) policyOpportunities for rapid career advancement across programs and therapeutic areasCollaborative, science-driven culture with a focus on impact and innovationAccess to world-class learning and development toolsPatient-centric mission and values-driven organizationInclusive and diverse workplace with a strong commitment to equityJobgether Hiring Process Disclaimer This job is posted on behalf of one of our partner companies. If you choose to apply, your application will go through our AI-powered 3-step screening process, where we automatically select the 5 best candidates. Our AI thoroughly analyzes every line of your CV and LinkedIn profile to assess your fit for the role, evaluating each experience in detail. When needed, our team may also conduct a manual review to ensure only the most relevant candidates are considered. Our process is fair, unbiased, and based solely on qualifications and relevance to the job. Only the best-matching candidates will be selected for the next round. If you are among the top 5 candidates, you will be notified within 7 days. If you do not receive feedback after 7 days, it means you were not selected. However, if you wish, we may consider your profile for other similar opportunities that better match your experience. Thank you for your interest!#LI-CL1

About WORKHUB AGENCY

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