Manager, Analytical Development

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: As the Analytical Development Manager, you will lead and oversee analytical activities supporting drug substance and drug product development across all phases of the product lifecycle. You will ensure successful development, validation, and transfer of analytical methods with a focus on scientific excellence, regulatory compliance, and cross-functional collaboration. Your leadership and technical expertise will be critical in advancing product development and regulatory submissions to deliver high-quality pharmaceutical products to patients globally.
Responsibilities:
• Lead and manage a team of analytical scientists responsible for developing, validating, and executing analytical methods for raw materials, intermediates, drug substances, and drug products.
• Provide strategic direction and technical oversight for method development, method qualification/validation, and analytical troubleshooting.
• Oversee analytical support for formulation development, process development, manufacturing, and stability studies.
• Ensure compliance with cGMP, ICH, and FDA guidelines in all laboratory operations and documentation.
• Review and approve analytical protocols, technical reports, specifications, and CMC sections of regulatory submissions (IND, NDA, BLA, etc.).
• Manage outsourcing of analytical activities to CROs and CDMOs, including method transfer, oversight, and data review.
• Drive continuous improvement initiatives, including implementation of new technologies and optimization of workflows.
• Support regulatory inspections and internal audits as an analytical subject matter expert (SME).
• Provide mentorship, training, and career development for direct reports to foster a high-performance team.
• Collaborate effectively with cross-functional partners in Quality, Manufacturing, Regulatory Affairs, and Project Management.
• Support qualification of new analytical laboratory equipment.
• Utilize creative thinking to generate solutions to complex technical problems.
• May be required to travel to attend or present at industry conferences.

Qualifications:
• Degree in scientific field: BS with 11+ years’ experience, MS with 8+ years’ experience, PhD with 6+ years’ experience
• 2+ years in a supervisory role
• Extensive knowledge of analytical techniques including HPLC/UPLC, GC, MS, UV, FTIR, compendial methods, etc.
• Strong understanding of regulatory and compliance requirements for analytical methods in pharmaceutical development and manufacturing.
• Experience authoring and reviewing analytical sections of regulatory submissions.
• Proficiency in analytical software systems (e.g., Empower, LIMS, CDS).
• Proven ability to lead teams, manage multiple priorities, and deliver results on time.
• Excellent written and verbal communication skills with demonstrated success in cross-functional collaboration.
• Strong organizational skills and attention to detail.
• Experience with both small molecules and biologics a plus.
• Familiarity with analytical Quality by Design (QbD), risk assessments, and statistical data analysis.
• Direct experience supporting regulatory agency inspections or audits.
# LI-Onsite


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