Head Process Development

Pune, Maharashtra (India)
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Head Process Development

Producción, Operaciones e I+D

Pune, Maharashtra (India)

Ref: JWX367 August 2, 2018 QUIMICA Y FARMACIA

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FUNCIONES

•Expertise in Upstream process development for CHO cells which includes fed batch/perfusion process and scale up to manufacturing scale. •Strong understanding and know-how for downstream process for monoclonal antibody. •Should have Proven Track Record of technical expertise through publication / patents IND BLA filings. •Should be able to bring in disruptive innovation in developing processes for products to reduce the cost of product maintaining the same quality. •Have strong interface with cell and molecular biology team with development approach and strategy. •Serve as subject matter expert related to upstream process development. This includes all process and manufacturing related activities, including risk assessments, characterization, investigations, regulatory interactions, and project team requirements. •Build a high performing group focused on execution, data analysis. •Mentor technical and junior staff to understand technical and regulatory requirements for process development. •Support upstream process control strategy for monoclonal antibodies manufacturing processes. •Oversee the execution of upstream process characterization studies. •Support tech transfer to manufacturing through authoring and change management of process descriptions (TTPs) •Plan and conduct experiments to define upstream manufacturing process parameters or optimized media formulations. •Collaborates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs. •Evaluate opportunities for improving process robustness or reducing Cost of Goods through process optimization •Build department of scientific excellence to enable prosecution of mAb biosimilar pipeline as well as other projects that may be assigned •Represent the Company before EU and FDA regulatory authorities. •Ability to support and effectively multi-task different and complex assignments and responsibilities

REQUISITOS

Qualifications and Skills PhD in Chemical Engineering/ Lifesciences/ Biochemistry or equivalent. ~10 years of Experience in Managing Biotech Process Development Group. Candidates must have exposure to large MNC. Desirable candidate should have experience of managing large team. He/She should have minimum 5 years of experience in managing team directly. Passionate about making a difference in contributing to society by bringing in disruptive innovation, for quality and cost effective biosimilar products to market. Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in timely. energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done Well-organized and accustomed to changing priorities and maintaining excellent records Soft skill competencies: Leadership Skills: Should be able to lead, coach and guide teams on process team. Communication: Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration Due to international nature of the tasks, fluency in written and spoken English Decision Making / Problem Solving Skill: Should be able to work in matrix organisation with strong decision making and problem skills. Process Improvement & Innovation: Should have good understanding of the process and innovation in biotech industry.

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