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Corden Pharma - A Full-Service CDMO
Corden Pharma - A Full-Service CDMO
1.001 – 5.000 Angajați
Asistență medicalăIndustria prelucrătoareProduse farmaceutice
Corden Pharma - A Full-Service CDMO este o organizație globală de dezvoltare și producție farmaceutică pe bază de contract, care deservește clienți de la programele clinice timpurii până la producția comercială. Capacitățile sale integrate includ ingrediente farmaceutice active (API), produse medicamentoase și excipienți lipidici, cu expertiză specializată în peptide, oligonucleotide, formulări cu nanoparticule lipidice (LNP), compuși foarte potenți și compuși oncologici, forme farmaceutice sterile și nesterile, precum și producția personalizată de lipide. Compania sprijină dezvoltarea și furnizarea de produse farmaceutice prin facilități conforme cu cerințele cGMP din Europa și America de Nord, combinând serviciile tehnice de producție cu managementul integrat al proiectelor.
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Director of Analytical Research and Development - Corden Pharma Colorado

Lead peptide API analytical development, validation, and CMC strategy in this onsite Colorado director role. Oversee teams, customer programs, budgets, and GMP-compliant operations across Corden Pharma’s CDMO network.

USStatele Unite ale AmericiiCOColorado
195.000 $ – 215.000 $ / an
La sediuNormă întreagăLiderLimbă Obligatorie: englezăDirector

Descriere

  • Align departmental objectives with the site’s strategic direction
  • Direct analytical method development and validation for peptide and small-molecule APIs
  • Provide technical leadership and manage the Analytical R&D Department at Corden Pharma Colorado
  • Oversee the design, development, and validation of methods for peptide programs
  • Build strong Development teams and promote cross-functional collaboration
  • Establish standard work and tactical plans that meet customer and site objectives
  • Support plant operations through method development or transfer for early-phase clinical GMP programs and validation for late-phase commercial products
  • Manage the Analytical R&D project portfolio to achieve on-time, on-budget delivery
  • Oversee IPC and release-method development, along with starting-material and regulatory starting-material testing
  • Assess new projects for risks, innovation potential, capabilities, costs, and pricing strategy
  • Create long-range analytical plans aligned with commercialization and regulatory milestones
  • Engage customers through meetings and joint steering committees
  • Direct the development, technology transfer, qualification, and validation of stability-indicating methods
  • Review and approve validation protocols and analytical method validation reports
  • Manage external partners involved in validation and testing
  • Develop Analytical R&D capabilities that support strategic priorities and competitive differentiation
  • Act as Analytical Technical Lead for Peptide Development Programs and establish CMC direction
  • Assess development needs and recommend appropriate management-team training
  • Review strategic technical work to maintain high-quality technical and quality outcomes
  • Maintain compliance with GMP, regulatory, safety, and environmental requirements
  • Manage functional leaders and direct reports across hiring, training, assignments, performance reviews, rewards, discipline, and issue resolution
  • Prepare and administer the Analytical R&D Department budget
  • Participate on the Development site Leadership Team and support operational oversight
  • Contribute to strengthening the Corden Pharma brand

Cerințe

  • PhD or equivalent in Chemistry, Analytical Chemistry, or a related discipline, plus 15 years of API development experience with a focus on peptide APIs, or an equivalent education and experience combination
  • Experience creating CMC strategies and delivering ICH-compliant method development and validation programs
  • Advanced analytical expertise in peptides and peptide-related products
  • Proficiency with HPLC, UPLC, SEC, LCMS/MS, CHN, AAA, IC, ICPMS, KF, IR, Raman, and related analytical methods
  • Ability to interpret scientific and technical literature, financial statements, and legal documents
  • Ability to address questions or complaints from customers, regulators, and business stakeholders
  • Ability to prepare speeches and articles for publication
  • Ability to present effectively to senior leaders, scientific and public audiences, and boards of directors
  • Ability to use advanced mathematics and statistical methods
  • Ability to define issues, gather evidence, establish facts, and reach sound conclusions
  • Willingness to travel domestically and internationally
  • Ability to occasionally lift or move items weighing up to 25 pounds
  • Understanding of the science and engineering fundamentals used in pharmaceutical manufacturing
  • Proven expertise in Analytical Development and Operations Management
  • Knowledge of Quality by Design principles and ICH regulatory guidance and frameworks
  • Expertise in solid-phase and solution-phase peptide synthesis
  • Knowledge of methods used to characterize peptide APIs containing 10–50 amino acids
  • Track record of leading and managing high-performing analytical teams
  • Project management capability
  • Strong analytical problem-solving ability
  • Working knowledge of pharmaceutical manufacturing regulatory matters
  • Leadership, negotiation, relationship management, influence, motivation, coaching, and mentoring capabilities
  • Excellent written, verbal, communication, and presentation skills
  • Experience working in international environments

Beneficii

  • 401(k) matching with 100% matching on the first 6% contributed and full vesting after two years of service
  • Accident insurance plan
  • Critical illness coverage
  • Dental insurance
  • Disability insurance
  • Employee Assistance Program
  • Flexible Spending Account
  • PPO/HSA health insurance
  • Hospital indemnity coverage
  • Identity theft protection
  • Life insurance
  • Paid parental leave
  • Tuition reimbursement
  • Wellness program
  • Three weeks of vacation during the first year
  • Vision insurance

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