Manager - Project Management (Biologics)

Job Description

Designation: Project Manager - Biologics Job Location: Bangalore Department: Global Program ManagementAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Syngene s innovative culture is driven by the passion of its 5000+ strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Job Purpose This role will support projects in Biologics operational unit at Syngene. And will be responsible for ensuring the Programs/Projects are delivered on time, budget and quality. This individual should be well-versed in Program management of Development, Technology transfer, Scale-Up, Manufacturing & outsourcing scenarios of Large molecules manufacturing.Key Responsibilities
• Responsible for scope setting, developing roadmap, and report building
• Lead the overall execution of Programs/multiple projects, including initiation, budgeting, scheduling, monitoring, and closure according to GLP, GMP, safety, and environmental requirements.
• Ensure vital communication within the project teams (meetings, minutes, action items) and coordinates / collaborates with other departments and Customer relationship management.
• To coordinate internal resources, third parties/vendors, and multidisciplinary activities to ensure that the project deliverables are on-time, in-full, and in quantity.
• Follow up and track all the actions coming from the PMO project meeting while tracking lessons learned.
• Handle project risks and strategic influencing to maintain project timelines and enhance productivity (operational efficiency)
• Create and maintain comprehensive program/Project documentation
• Responsible for weekly and monthly reports by partnering with all the stakeholders to collect and analyze data and structure weekly/monthly reports for final submission.
• Effectively apply PMI methodology and enforce project management standards.
• Responsible for driving portfolio strategies and initiatives as part of operational management and effectiveness.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace
• Ensure environment, health, and safety (EHS) measures are adhered within the team
Educational Qualification
• Masters in life sciences, with a background in large molecules (Biological) process development and manufacturing like Biosimilars, antibodies, Biotherapeutics, Vaccines, etc., or Master s in Business administration with Program/Project management experience in the Biopharma industry.
• PMP certification or six sigma/Prince 2/ Agile certifications.
• Synpro academy certification (Stage 1& 2) desired, but not mandatory
Technical/ Functional Skills
• Must possess full fluency in MS Office (Word, Outlook, PowerPoint) with knowledge of using Microsoft Project (MS Project, Primavera) to monitor, control, and provide overall visibility to the organization.
• Knowledge of manufacturing (process, equipment, facility, automation) & quality (GLP, cGMP, 21 CFR Part 11 validation, etc.). Good understanding of product development lifecycle.
• Knowledge of Quality Assurance, CAPA, Change Control, Document Control, Training Systems
• The operational excellence attitude is critical as projects and processes in the Biologics operating unit need PM to coordinate cross-functional resources in Operations, Quality, and other supporting functions.
• Strong oral and written communication skills
Experience
• At least 10+ years of project management experience with a minimum of 14 years of overall experience in Contract research organization or pharmaceutical industry
• An added advantage with experience in operational excellence/improvement projects focused on standardization, scalability, and robustness in development and manufacturing environments.
Behavioral Skills
• Self-directed, proactive, responsive, and able to handle competing priorities with the ability to work independently with minimal direction
• Ability to focus on a variety of issues and aim to drive results; interact with a variety of stakeholders and foster cross-functional / cultural teamwork
• Great teammate and strong stakeholder management skills
• Must be service-minded, flexible, and possess strong interpersonal skills. The ability to handle multiple conflicting tasks in a fast-paced environment is a must.
Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, and/or expression, genetic information, marital status, status with regards to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. Besides, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

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