Senior Manager

Senior Manager, Pharmaceutical Clinical Trial Material Manufacturing

Full Time

Exton PA

Frontage Laboratories

Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.

Responsibilities:

• Manage the manufacturing and supply of clinical trial materials (CTM), Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing in phase -IV.
• Manage CTM production scheduling and forecasting in collaboration with Product Development and Formulation functions.
• Manage daily, routine product manufacturing and related tasks. Assure completion of daily manufacturing workload. Oversight of schedule for direct team members.
• Develop and implement technically sound Clinical Manufacturing batch records, SOPs, protocols, and specifications as required, while adhering to good documentation practices (GDP).
• Serve as the Subject Matter Expert (SME) and use knowledge of scientific techniques to troubleshoot processing or product quality issues with a sense of urgency.
• Lead the receipt of technical transfers from Process Development (PD) Team, ensuring appropriate equipment purchase, assisting with processing COGs and timelines, and initiating manufacturing suite set-up.
• Lead deviation investigations and support on-time closure of deviations and CAPAs for areas of focus.
• Ensure overall inspection readiness for area of focus and participate as an SME in regulatory agency inspections.
• Provide routine feedback and updates to departmental leadership on product/process KPIs.
• Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM in accordance with clinical study timelines and demand plans.
• Managing the review of production and quality control records and the review and approval of Change Controls, CAPAs and other GMP related documents.
• Development of clinical trial material packaging and labeling configuration.
• Ensure considerations of efficiency, accuracy, timeliness, and cost savings are incorporated into all aspects of production, forecasting and distribution of CTM.

Qualifications:

• BS degree in Pharmaceutical, Life Science or related scientific discipline, Master’s degree preferred.
• 5+ years’ relevant experience with clinical manufacturing, gowning, and operation within cGMP environments. Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
• Strong knowledge of GXP regulations (cGMP, cGDP etc.)
• Strong organizational and time management skills.
• Ability to work well in a team environment, eager, adaptable.
• Excellent verbal and written communication skills as well as strong focus and attention to detail.
• Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
• Flexible scheduling required.
• Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts.
• Dynamic individual with the ability to communicate and engage others.
• Independent and self-starting.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability