Manager, Operations and Engineering

Summary of Role
As the Manager, GMP Operations and Process Engineering you will be responsible for leading GMP production operations to drive continuous improvement in the areas of Safety, Quality and Productivity. Reporting to the Site Executive Vice President, the primary responsibilities include management of the GMP production operations, leading the implementation New Processes into GMP production, of corrective actions and process changes, and overall leadership and direction of hourly and salaried production workforce. As a key member of the Site Leadership Team, this position will advise on developmental projects to improve safety, production processes, manage capital projects for company growth and resolve quality issues. The position requires superior leadership behaviours of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Your Responsibilities

• Responsible for driving a culture of superior Safety in a Chemical Manufacturing Environment.
• Fosters customer-focused, right-first-time, cost-effective production environment.
• Ensure site maintains an organized and orderly workflow for operational excellence.
• Collaborates with internal functions to ensure continuity and effectiveness of programs.
• Develop processes and procedures for GMP operations while ensuring we are meeting customer requirements for GMP products.
• Oversee capital projects to build out new GMP suites and infrastructure to increase capacity and meet appropriate regulations.
• Leads and actively participates in client interface regarding new and existing client relationships.
• Identifies critical path/activities, risks, contingencies and alternatives to improve the efficiency of the groups.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Serve as a consultant to the customers on their filing strategies and documentation.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Requirements for the Role

• Bachelor's degree in engineering or chemistry with 7+ years of related experience, in cGMP manufacturing.
• Prior pharmaceutical manufacturing experience required; prior CDMO experience preferred.
• Proven ability to be an effective hands-on leader.
• Functional knowledge of project management, process chemistry, GMP and EHS guidelines.
• Excellent verbal and written communication skills as well as presentation skills required.

What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Location
The position is in Cary, NC, which is found right in the heart of the Triangle area. As one of the fastest-growing cities in the southeast, Cary is home to everything that you can imagine including award-winning restaurants, booming businesses, luxurious shopping centers, top-rated entertainment options, excellent educational opportunities, outdoor experiences, and a great culture that welcomes everyone.
Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.