Glatt Group
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.
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.