Director, Technical Operations - Lexington, United States - Piramal Group

Piramal Group Lexington, United States

1 week ago

Description

Job DescriptionKey Responsibilities Successful achievement of revenue related targets and identification of new revenue opportunities All operational aspects of manufacturing, including: productivity, cost, planning, daily business processes, cGMP compliance Key contributor to positive client relationships by ensuring adherence to customer requirements/specifications, open communication, and resolution of any issues Evaluation of potential new clients, vetting of project scope and technical capabilities Ensure successful technological transfer of new products developed from R&D to clinical/commercial manufacturing and commercial site transfers Facilitate alignment of technical services, engineering, maintenance, and production operations to minimize downtime, improve processes, and improve quality Establish demand plan and detailed schedule, articulate key financial milestones for forecast Drive manufacturing technology, automation, and facility strategies Lead, coach, and provide direction to direct reports, as well as indirect reporting relationships Management of the corporate CapEx budget, ensuring capital investments are appropriately executed Management and oversight of multiple departmental budget(s)

Collaborate with Project Management team to ensure that technical operations' resources are effectively deployed and meet client expectations Collaborate with Quality/Validation to support the validation lifecycle of all equipment, utilities, facilities, systems and processes Skip-level oversight of the engineering, maintenance, calibration and operations functions, including:
project and process engineering, instrumentation, control systems, automation, and preventative maintenance systems Establish and track the relevant KPIs to improve the efficiency and quality of the entire GMP operation Partner with Business Development, Project Management, R&D, and Quality Leadership teams to ensure compliance within the quality systemQualifications

Education Requirements:
Bachelor's Degree in applicable scientific field, including: Mechanical, Biological, or Chemical Engineering, Operations Management, or Life Sciences

Work Experience:
Minimum fifteen (15) years working within pharmaceutical manufacturing environment, must include aseptic filling/lyophilisation experience Contract Development & Manufacturing Formal leadership experience, including P&L responsibility, revenue achievement, and talent management activities

Functional Or Technical Skills:
Expertise in sterile manufacturing In-depth knowledge of Engineering activities, including: developing specifications, facility design, product development, project portfolio management Thorough working knowledge of cGMPs, including: FDA, JP, and EU regulations Proficiency and understanding of cGMP quality systems, including: CA/PA, root-cause analysis, risk assessment and investigation tools and techniques Demonstrated success in leading cross-functional teams and achieving goals Tactful communication skills, both written and verbal Proven track record of forging positive working relationships with other leadership team members and use influence to achieve site goals Understanding of typical CDMO for service contracts and legal agreements Ability to understand cultural differences and modify behaviors to support global customer relationships Understanding of isolator technologies

Director, Technical Operations

1 week ago

Piramal Group Lexington, United States

Job Description · Key Responsibilities Successful achievement of revenue related targets and identification of new revenue opportunities · All operational aspects of manufacturing, including: productivity, cost, planning, daily business processes, cGMP compliance · Key contributo ...
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