Job Summary:
The Lead Technical Services Scientist / Supervisor provides technical and people leadership for all new liquid pharmaceutical products. This role is responsible for ensuring the safe, compliant, efficient, and robust manufacture for development products through process ownership, leading the investigation of critical manufacturing deviations, oversight of exhibit batch manufacturing.
This position has direct supervisory responsibility for the Development Technical Services team and serves as the primary technical escalation point for manufacturing operations.
Supervisory Responsibilities:
Direct supervision responsibility, including performance assessments.
Duties/Responsibilities:
• Effectively lead and direct TS Scientists in support of manufacturing process development for new products and technology transfer activities.
• Serve as the scientific and technical lead for assigned development products, ensuring clear process understanding with defined control strategies and successful execution of exhibit batches. Propose scale-up strategy to establish robust manufacturing processes suitable for commercial production, and identification and mitigation of technical risks.
• Provide technical support to the Technical Services Packaging group as needed, including development and execution of packaging studies, authoring protocols and reports, and supporting investigations related to packaging processes for development products
• Generate, review, and approve technical documentation to support exhibit batch manufacturing and regulatory filings, including FDA submission documents (e.g., eCTD sections), batch records with side-by-side comparisons, protocols, reports, change controls, and other project-related documentation.
• Assess process capability and manufacturing readiness to support exhibit batch manufacturing as applicable to new products.
• Assess current manufacturing equipment and facility capabilities to support new process development and scale-up. Identify gaps or limitations, define the need for new or modified equipment, and collaborate with Engineering during development of User Requirement Specifications (URS) to ensure equipment design meets process requirements.
• Support validation groups during equipment validation/qualification activities by providing scientific input, authoring or reviewing validation protocols and reports, and ensuring alignment with proposed manufacturing processes for development projects and regulatory expectations.
• Collaborate closely with key cross-functional areas (i.e., Operations, Quality, Engineering, Validation, Maintenance, Regulatory, and R&D) during manufacturing process troubleshooting and investigations. Apply sound scientific judgment and technical expertise to develop and recommend effective solutions.
• Monitor progress of assigned projects, communicate status and risks to management, and proactively resolve issues. Effectively manage and coordinate resources to meet project timelines, quality standards, and company objectives.
• Ensure staff are adequately trained to perform job assignments in compliance with cGMP requirements. Identify, develop, and maintain relevant training materials (e.g., SOPs, WIs, protocols) and provide ongoing technical guidance to fully develop team capabilities and performance.
• Participate in personnel-related activities in collaboration with management, including interviewing, hiring, onboarding, coaching, and mentoring of Scientists and supporting staff.
• Regularly review staff performance and actively support professional development to enhance individual effectiveness and overall team performance.
Required Skills/Abilities:
• Competent in English with strong written and verbal communication skills. Strong initiative and integrity as well as technical writing skills with attention to detail. Exceptional presentation and analytical skills.
• Ability to work in a team environment as well as independently. Ability to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is required.
• Knowledge of and experience in pharmaceutical manufacturing and packaging processes.
• Strong customer orientation; ability to develop relationships and effectively influence at all levels internally (e.g. management teams) and externally (e.g. contractors).
• Ability to work flexible hours.
Education and Experience:
• Bachelor's Degree in engineering or science (i.e., Pharmaceutical, Chemistry, Biology) plus a minimum of 8 years of pharmaceutical manufacturing experience. Or equivalent combination of education and experience. Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA). Oral liquid pharmaceutical experience preferred
• To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily.
