AR&D Manager

KVK Tech is seeking an AR&D Manager to join our team in Newtown, PA.

The AR&D Manager will provide strategic, technical, and operational leadership for all Analytical Research & Development laboratory functions supporting product development, stability programs, raw materials, intermediates, and finished products. This role oversees analytical method development, validation, transfer, troubleshooting, and compliance activities, ensuring readiness for regulatory expectations and alignment with cGMP, GLP, and data integrity standards. The ideal candidate will be a strong scientific leader capable of managing complex analytical portfolios, guiding a team of chemists, resolving high-impact technical challenges, and driving continuous improvement across laboratory operations.

This position’s responsibilities will include, but not be limited to the following:

• Lead day-to-day AR&D laboratory operations, ensuring efficient workflow planning, resource allocation, and timely execution of development and stability commitments.
• Oversee method development, optimization, validation, and technical transfer activities in alignment with ICH, FDA, and USP requirements.
• Review and approve analytical documentation—including protocols, validation reports, development summaries, and investigations—to ensure scientific accuracy and regulatory compliance.
• Serve as the primary technical escalation point for complex analytical challenges, OOS/OOT investigations, method robustness concerns, and instrument troubleshooting.
• Ensure laboratory compliance with cGMP, GLP, data integrity expectations, and equipment lifecycle requirements, including qualification, maintenance, and calibration.
• Provide leadership, coaching, and performance management for Analytical Chemist I–III staff, fostering technical growth and accountability.
• Collaborate cross-functionally with Formulation R&D, QC, QA, Regulatory Affairs, and Manufacturing to support development programs and resolve technical issues.
  
  

We Are Looking For Applicants With

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field; Master’s degree or higher preferred.
• 8–12 years of analytical experience in a cGMP pharmaceutical or biotechnology environment, with at least 3–5 years in a leadership or senior-level technical role.
• Extensive expertise in HPLC/UPLC (required), GC (preferred), and analytical method development, validation, and troubleshooting.
• Demonstrated ability to lead complex investigations, drive scientific problem-solving, and ensure regulatory-compliant documentation.
• Strong leadership, communication, and organizational skills, with proficiency in chromatography data systems and standard office software.
  
  

What We Offer

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays
  
  

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.

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