AR&D Manager

Responsibilities

• 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.

Requirements

• 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.

Qualifications

Knowledge of cGMP, GLP, and data integrity standards is essential. Proficiency in chromatography data systems and standard office software is required. Experience with raw materials, intermediates, and finished products is preferred.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in HPLC/UPLC, GC, and method development/validation.

Benefits

• 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

Pay

Compensation is commensurate with experience.

Schedule

The position offers a flexible schedule.