Job Description

We are seeking a highly skilled and experienced Associate Director, Technology Transfer to join our Sellerville operations team. The successful candidate will oversee the safe, efficient, and compliant transfer of process technologies from R&D to manufacturing, ensuring adherence to cGMP, regulatory standards (FDA, EPA, OSHA), and company policies. This leadership role requires strategic thinking, technical expertise in process chemistry, and a commitment to operational excellence

Role

• Lead the development of manufacturing estimates for new inquiries and repeat production (RFP), ensuring optimal capacity utilization across labs, kilo labs, and manufacturing bays.
• Collaborate with multidisciplinary teams (Technology Transfer, Production, R&D, Engineering, Quality Assurance, and Lab Services) to facilitate the scale-up of chemistry and process technologies in compliance with company policies and regulatory requirements.
• Provide technical guidance and oversight for process investigations, troubleshooting, and problem resolution related to materials, processing, and manufacturing issues.
• Communicate effectively with clients and internal stakeholders regarding production status, challenges, and solutions.
• Review and approve process documentation including Master Batch Records, Specifications, SOPs, Change Controls, Validations, and Hazard Evaluations.
• Participate in Process Failure Mode and Effects Analysis (PFMEA) and risk assessments for current and new product introductions.
• Develop and optimize process workflows and procedures to ensure robust technology transfer and manufacturing processes.
• Ensure compliance with cGMP, safety, and environmental standards, leading internal and external audit preparations.
• Manage procurement of raw materials and intermediates in collaboration with Purchasing to meet production schedules.
• Support the evaluation and implementation of new technologies and process improvements in the manufacturing environment.
• Lead and develop staff through recruitment, training, performance management, and scheduling.
• Drive operational excellence initiatives and stay current with industry trends in process chemistry and manufacturing.
• Develop and manage the technology transfer budget, ensuring cost-effective operations.
• Promote a culture of safety, compliance, and continuous improvement across the site.
• Provide training on cGMP, safety procedures, and new manufacturing processes for personnel.

Qualifications & Experience:

Ph.D. in Chemistry, preferably with specialization in synthetic organic chemistry.

Postgraduate experience in industrial or academic settings focusing on process chemistry.

Extensive experience in process chemistry and cGMP manufacturing within the pharmaceutical or API industry, with leadership experience preferred.

Proven track record in technology transfer, process validation, and scale-up activities.

Strong knowledge of production equipment and capabilities in pilot plant and kilo lab environments under cGMP regulations.

Familiarity with FDA, EPA, OSHA, GMP, and 21 CFR Part 11 regulations.

Business acumen with coursework or experience in project management and cost control is advantageous.

Skills & Competencies:

Expertise in synthetic organic and process chemistry.

Proficiency in MS Word, Excel, PowerPoint, Project Management tools, and web browsers.

Excellent project management and leadership skills.

Strong communication and interpersonal skills to effectively liaise with clients, vendors, and cross-functional teams.

Ability to lead change, promote safety culture, and ensure regulatory compliance.

Join Piramal Pharma Solutions at our Sellerville site and be part of a dynamic team dedicated to advancing pharmaceutical innovation through excellence in process development and manufacturing.

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