Job description
Leads site Manufacturing Sciences & Technology (MS&T) function in providing:
Scientific and engineering support for commercial manufacturing
Technology transfers
Process stewardship Overall
Provides leadership for the site MS&T organization with a focus on technical competency, verbal and written communication, teamwork and problem solving
Fosters communication and networking across the MS&T divisional sites
Key member of site leadership team and global MS&T organization and expected to play a full part in driving continuous improvements and supporting strategic developments Scientific and engineering support for commercial manufacturing
Directs, advises, guides and coaches M&T associates for the purpose of ensuring routine operational support, identifying solutions and improvements, solving problems and decision making
Leads team in providing support for facility, equipment and automation design efforts
Supports regulatory compliance through technical expertise for regulatory inspections and CMC document preparation
Leads manufacturing floor support for troubleshooting, mentoring, training and general technical oversight of process.
Attends routine PU meetings, investigational process review meetings, and technical meetings Technology transfers
Responsible for both Internal/External transfer of licensed products into the local site (receiving role) and for transfer of local products to other sites (sending role)
Ensures that transfers are executed ‘right first time’ in terms of correct technology match (equipment, materials) and that effective handover to the manufacturing operations/PU occurs Process Stewardship
Ensures that the appropriate technical competencies/knowledge and ownership (Product Stewards) are identified and available to support the site’s chemical/biological processes (as applicable) and that effective support and leadership is provided for on-going commercial operations
Ensures manufacturing processes are validated and remain in constant state of validation throughout the manufacturing life of the product (including continuous monitoring)
Provides meaningful and up to date scientific/technical input into user Requirement Specifications.
Stays abreast of technological, regulatory and industry developments, e.g. via internal and external benchmarking
Desired Skills and Experience
PhD in Chemistry, Biochemistry, Pharmaceutical Science, Chemical engineering or related scientific or technical discipline from accredited Technical University, MSc with appropriate experience would be accepted
English fluent in speaking / writing. Fluency in the language of the site desirable
Minimum of 5 years of relevant technical and cross-cultural leadership experience in the pharmaceutical industry, including manufacturing plant experience
Thorough knowledge and understanding of the scientific principles and concepts in chemical & pharmaceutical sciences
Good interpersonal skills coupled with demonstrated networking capacities allowing to effectively working in a matrix organization
Good understanding of cGMPs, industry and regulatory standards and guidelines, strong ethical foundation and a sound compliance understanding
Broad experience in the technical transfer of processes
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Email: jobs@aarenconsultants.in
