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Director Analytical Development jobs in United States
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Contract Pharmacal Corp · 9 hours ago

Director Analytical Development

Contract Pharmacal Corp is seeking a senior analytical leader to support the Vice President of AR&D. This role involves bridging the gap between leadership and laboratory scientists, ensuring analytical development work is sound and aligned with business priorities while providing scientific oversight and mentoring to scientists.
BiotechnologyPharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Kristyn Tulley, M.S.
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Responsibilities

Act as a technical and operational bridge between AR&D leadership and laboratory teams
Provide scientific oversight for analytical method development, validation, transfer, and investigations
Ensure analytical deliverables are executed on schedule and aligned with overall project timelines and business priorities
Prepare and review methods, protocols, reports, and regulatory-facing documentation
Partner cross-functionally to support CMC and submission-enabling activities
Help translate strategy into clear priorities, timelines, and execution
Mentor scientists, strengthen technical rigor, and reinforce a culture of quality and accountability

Qualification

Analytical techniquesTechnical writingLeadership skillsCGMP knowledgeProject managementMicrosoft Office proficiencyCommunication skillsProblem-solving skillsOrganizational skills

Required

BS, MS, or Ph.D. in Chemistry, Pharmaceutical Sciences, or a related scientific discipline
Manager level: 5+ years of experience in analytical development
Senior Manager: 7+ years of experience in analytical development
Director level: 10+ years of progressive experience in analytical development
Prior experience supporting method development, validation, and regulatory submissions (CMC/ANDA) required
Broad, working knowledge of analytical techniques, including chromatography (HPLC, UPLC, LC-MS, GC, GC-MS, ICP-OES/MS, TLC/HPTLC), spectroscopy (UV-Vis, FTIR), and classical/wet chemistry
Strong understanding of cGMP, data integrity principles, FDA and ICH guidelines
Exceptional technical writing skills with the ability to produce clear and concise documentation
Ability to translate complex scientific concepts for both technical and non-technical stakeholders
Proven leadership skills with the ability to influence without authority and bridge leadership and bench-level execution
Strong organizational, prioritization, project management, communication and problem-solving capabilities
Proficiency with standard business and documentation tools (e.g., Microsoft Office)

Preferred

Experience leading or mentoring scientific teams strongly preferred

Benefits

Competitive benefits

Company

Contract Pharmacal Corp

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Contract Pharmacal Corp is a pharmaceuticals company specializing in solid dose drugs and dietary supplements.

H1B Sponsorship

Contract Pharmacal Corp has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2023 (6)
2022 (5)
2021 (7)
2020 (8)

Funding

Current Stage
Late Stage

Leadership Team

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Larry Lapila
Vice President of Business Development
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Glenn Langberg
Chief Strategy Officer (CSO)
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Company data provided by crunchbase