Director, Manufacturing Operations

Location: NJ - Bloomsbury Site, 519 NJ-173, Bloomsbury, NJ 08804, USA.

Our Director, Manufacturing Operations plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include overseeing the support of site and company-wide objectives through the reporting of department Key Performance Indicators (KPI). Meeting quality, safety, delivery, and productivity objectives. Ensures people and processes comply with current Good Manufacturing Practices and company procedures.

• Support site and company-wide objectives through the reporting of department Key Performance Indicators.
• Ensure people and processes comply with current Good Manufacturing Practices and company procedures.
• Modify department standard operating procedures and execute change controls to support business and quality objectives.
• Establish and maintain cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, Research & Development, and Supply Chain to meet site and corporate objectives.

• Direct and plan the overall company’s pharmaceutical production operations.
• Run operations to meet or exceed delivery performance and customer service objectives.
• Establish and ensure that cGMP compliant policies, processes, procedures and best practices are developed and consistently executed across manufacturing operations and provide support and guidance on policy related matters.
• Counsel and develop colleagues for efficient performance; provide constructive feedback; create an atmosphere of team effort and open communication.
• Ensure that all production areas have the processes, equipment, and adequately trained staff to support the company growth goals and meet customer demand.
• Troubleshoot and resolve issues impacting deliverables; proactively demonstrate ownership to achieve them.
• Maintain and report key performance indicators and elevate any identified risks to permit timeliness remain contiguous.
• Maintain a contemporaneous working knowledge in cGMP requirements.
• Other duties that may reasonably be assigned from time to time by the company.
• This is a security-sensitive position as the incumbent works with controlled substances and therefore will be subject to periodic drug screen per company policy.
• Consistently promote and support best practices involving work methods (lean methodology), technology, and operational systems in order to remain innovative and to maintain and/or increase quality of production methods and final product quality.
• Provide leadership and direction to the team to assure consistently high levels of performance in pharmaceutical operations.
• Lead employees to meet the organization’s expectations for safety, quality and productivity goals.
• Manage the overall operational, budgetary, and financial responsibilities and activities of the manufacturing operations departments.
• Provide input toward selection, hiring and placement of personnel within the departments as needed.
• Actively participate in performance evaluations.
• Other duties as assigned.

• Can organize large volumes of data.
• Is experienced in pharmaceutical manufacturing especially sterile injectable.
• Is an expert in pharmaceutical manufacturing.

• BA/BS Degree in Business, Science or related field or significant experience.
• 5 years’ experience in managing a cGMP manufacturing plant operation required.
• 7-10 years of related experience in cGMP/FDA regulated industry (CFR 201 & 211 emphasis on FDA guidance for industry aseptic processing preferred).
• Demonstrated experience and leadership in cGMP compliance audits and inspections required.
• Demonstrated knowledge of lean manufacturing and metric concepts preferred.
• Demonstrated ability to increase others’ knowledge of cGMP regulations and guidance preferred.
• Proficient in computer skills (e.g. Microsoft Office suite: Visio, ERP systems, MS Project).

• Comprehensive health and wellness benefits…