Job Description

About this role:

The primary accountability of this role is to ensure client success by leading, planning, and executing a broad portfolio of development projects. This includes oversight of formulation and process development activities from pre-formulation through clinical batch production and process validation. The role is both technical and strategic, involving team leadership, client engagement, and scientific direction to support new business opportunities.

This is a “safety sensitive” position and is subject to random drug testing.

Responsibilities:

• Provide leadership and direction to the formulation and process development team, ensuring high-quality execution of client projects.
• Manage and oversee the entire client project portfolio, ensuring alignment with timelines, scope, and quality standards.
• Act as the primary technical resource for new client engagements and relationship-building.
• Partner with Business Development to attract new clients through scientific outreach and support for client visits and training seminars.
• Lead, mentor, and develop a high-performing team of scientists and engineers, promoting collaboration and innovation.
• Offer technical expertise in formulation, scale-up, and process optimization.
• Develop internal requirements to align with regulatory standards (IND, NDA, ANDA, etc.) and ensure proper documentation and quality.
• Collaborate cross-functionally with QC, QA, Manufacturing, Procurement, Sales, and Business Development to support integrated drug development and tech transfer.
• Drive process optimization and identify opportunities for efficiency and innovation.
• Identify and mitigate project risks and ensure effective client communication.
• Stay current on industry trends and emerging technologies to guide innovation and support business growth.
• Perform additional tasks as assigned by management.

Qualifications:

• Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• 7+ years of proven success in pharmaceutical formulation development, scale-up, and process engineering.
• Experience with solid oral dosage forms, fluid bed processing, and Wurster coating.
• Demonstrated ability to lead teams, make decisions, and take ownership of outcomes.
• Strong working knowledge of FDA, cGMP, ICH, and regulatory submissions (IND, NDA, ANDA, 505(b)(2)).
• Experience with client-facing roles in pharma; CDMO experience preferred.
• Familiarity with Glatt equipment is a plus.
• Excellent communication, organization, and problem-solving skills.
• Strong business acumen and strategic thinking.
• Must be self-motivated with a passion for the pharmaceutical industry.

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