Drug Product GMP Lead - CDMO

Job Description

Role & responsibilities The candidate should lead DP manufacturing within the Process Sciences group. The role entails utilization of the prospective candidates vast technical experience to lead a team that will be focused on manufacturing of drug product of clinical grade product quality. Specific Job Responsibilities: Strong understanding of DP unit operations like freeze/thaw, filtration, filling, lyophilization, visual inspection, leak detection and packaging. Strong understanding and provide technical leadership for manufacturing aspects for clinical DP including aseptic and compliance aspects in GMP setting. Identify best DP technologies and work with vendors to custom design filling equipment for GMP manufacturing, implementation of critical aseptic compliance aspects like control of bioburden, implementation of PUPSIT. Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects. Support drug product filling line mock up review, functional design review, on site support of FAT and SAT for drug product filling line. Technical leadership for critical validation aspects of DP like media fills, filter validation, hold times, capping. Set up visual inspection program including operator training kits, qualification program. Set up packaging operations for clinical drug product supply. Provide operational expertise and leadership in managing production of clinical material in GMP setting for fill and finish, with deliverance on critical KPIs like right on time, yield and product quality. Technical leadership for troubleshooting of deviations and assess for root cause, implementation of corrective actions and assessment of product quality. Strong understanding of documentation requirements and data integrity applicable for running manufacturing operations. Strong understanding of Annex 1 requirements for aseptic processing. Work with IT and Engineering to ensure that data on manufacturing process parameters, and batch data is accessible and available in formats for data analysis. Must be focused on usage of statistical tools to evaluate process performance and process consistency. Good collaboration skills with clients Responsible for authoring and reviewing technical reports related to drug product, and contribute to regulatory submissions and audits with health agencies. Identify and communicate best practices within the CDMO function. Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development Core Competencies Drive for results Highest integrity, committed to ethics and scientific standards. Uses an approach to address the task or situation such as delegation, planning, timelines. Perseveres to find ways to work through localized challenges or barriers. Building Effective Teams Empowers team members and encourages them to contribute their skills/ideas. Gets the right talent mix for the task. Shares credit and celebrates wins. Process Management Strong organizational skills, including the ability to prioritize personal and direct reports’ workload. Abreast with the latest technical innovations and familiarity with Regulatory expectations Simplifies complex processes. Makes process improvements where value addition is relevant and important. Resourceful, uses resources and people wisely. Be data driven if providing solutions to challenges – also should have the ability to take calculated risks and manage the risks in the most transparent manner. Very good understanding and implementation of the best documentation practices including paper and electronic record keeping. Sufficient industry experience in handling cross functional interactions. Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups. Relevant Functional/Technical Skills or Industry Experience Experience in drug product operations (fill and finish) in a GMP setting is required. Experience of leading and managing a team in the bio-pharma industry is very much preferred. Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing, visual inspection and packaging operations. Strong operational expertise in running aseptic operations for drug product manufacturing, and understanding of compliance and implementation aspects around cross contamination, microbiological contamination and facility layout for GMP manufacturing. Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects. Experienced in supporting drug product filling line mock up review, functional design review, on site support of FAT and SAT. Preferred to have knowledge of fill finish of complex biologics like antibodies (monoclonal, bispecifics), recombinant proteins and enzymes. Cross functional technical knowledge is highly desirable. Excellent oral and written communication and interpersonal skills will be desired. Relevant Professional / Educational Background: Masters or Ph.D in Chemical/Biochemical Engineering or similar disciplines with 12+ years of work experience in drug product development and manufacturing or B.Tech/B.E in Chemical/Biochemical engineering or similar disciplines with 14+ years of work experience in drug product development and manufacturing.