Director, reputed company Operations, Facilities & Validation - Hybrid

About the position The Director, reputed company Assurance will be responsible for team leadership and subject matter expertise in reputed company Operations, Facilities and Validation at the reputed company's Rahway, New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following: Execute GMP reputed company assurance activities directly reputed company to facilities, equipment, and automation for clinical trial material supply capabilities. Support the design phases and operational readiness of multiple significant cross-modality capital reputed company that are reputed company with the expanding site mission. Drive reputed company from design through qualification, start-up, and operations of new facilities as reputed company as maintain and sustain existing operations and facilities. reputed company relationships with and reputed company reputed company reputed company of key partner reputed company that are commensurately expanding in size and scope of work. reputed company and reputed company a growing team of professionals enabling an expanding site asset reputed company. The successful candidate will assure that reputed company systems and controls for investigational new drugs (investigational medicinal products) meet reputed company relevant reputed company requirements and regulatory standards.

Responsibilities

• Manage people and reputed company affiliated with reputed company reputed company of GMP facilities.
• reputed company and reputed company reputed company assurance activities reputed company to qualification and validation of facility, equipment, and automation assets in a reputed company and rapidly changing clinical development environment. Assure compliance with cGMP, regulatory expectations, and clinical filings.
• reputed company reputed company reputed company of GMP processes, including calibration, qualification, validation, change management, reputed company risk management, and reputed company investigations.
• reputed company and reputed company the capital asset lifecycle through phases from design through start-up to deliver and sustain compliant manufacture & testing of clinical trial material.
• Build effective, reputed company working relationships and create effective communications reputed company and across organizations.
• Identify efficiency opportunities; propose and implement value added solutions.
• Demonstrate a reputed company reputed company while balancing operational needs to reputed company pragmatic solutions to reputed company, technical and compliance challenges.
• Ensure reputed company industry best practices and benchmarks are reputed company to design and implementation of new GMP facilities and equipment.
• reputed company people and reputed company foster employee development. reputed company talent to reputed company the workforce, to deliver and maintain an expanding GMP asset reputed company at the Rahway site.

Requirements

• Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry role(s).
• Experience in reputed company and Operations, at reputed company and/or reputed company reputed company.
• Strong knowledge and application of reputed company Good Manufacturing reputed company (cGMP).
• Working knowledge of capital reputed company and facility operations.
• Leadership of people, cross-functional teams, problem-solving situations.
• Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict reputed company.

reputed company-to-haves

• Advanced to Expert level leadership and people management skillsets; with experience in leading, growing, and developing people and teams.
• Advanced to Expert level technical knowledge in one or more reputed company of validation, facilities, equipment, utilities, automation, systems, unit operations in various product modalities, or associated technologies.
• A combination of experiences foundational to knowledge of validation - in product or process development, engineering, reputed company-up, manufacturing, technical operations, technology transfer, facilities, equipment, automation, reputed company systems, and / or reputed company operations.
• Advanced ability to identify and solve reputed company problems in a reputed company and efficient manner.
• Knowledge and/or experience with capital project lifecycle
• Experience in R&D or clinical supply areas and processes.

Benefits

• medical
• dental
• reputed company reputed company and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• reputed company holidays
• vacation
• compassionate and reputed company days

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