Associate Director, Technical Operations Position Available In Guilford, North Carolina

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Associate Director, Technical Operations is responsible for chemical engineering functions and technical supervision of production activities at CHP, including direct supervision of the ERD (Engineering Research and Development) team, Process Engineering, batch record authoring and Manufacturing Chemist supervisory functions. ERD leadership is focused on key customer support, including optimization of existing chemical processes and (when appropriate) development of novel alternate chemistries/processes toward key synthetic intermediates and APIs, including full safety evaluation of all chemistries planned for on-scale production. Position requires e xperimental skills related to chemical process development, technical transfer and scale up (both internal and external) and continuous manufacture, including kilo – scale production. Position p rovides CHP site engineering support, including the design, construction, and maintenance of equipment that replicates laboratory chemical processes on pilot and commercial scales. Serve as an expert in chemical engineering and pharmaceutical science resource to the chemical development group, the Cambrex High Point site, and to the larger Cambrex organization. Supervise Process Engineers and Manufacturing Chemist on technical aspects of both clinical and commercial manufacture. Communication with clients in regular team meetings. Works with proposal writers as the engineering SME (subject matter expert) in the development of customer quotations for Cambrex client RFQs. Assists the Sr. Director Operations with duties related to key capital projects, maintenance requests, and manufacturing facilities responsibilities while complying with FDA, OSHA, EPA, DEA and company standards and requirements . Responsibilities Provide daily oversight of Engineering R D and Process Engineers and Manufacturing Chemists. Provide guidance, monitor schedules and work activities and ensure that technical support is readily available. Ensure safe and effective operation of the noted departments and exercise the ability to communicate effectively to achieve stated goals. Monitor production to ensure customer expectations are met for quality and timing of delivery. Communicate daily with the Sr. Director, Operations, and as necessary the Site Director, Head of Quality, and Head of Chemical Development (and their respective teams) to ensure client and contractual timelines and quality objectives are met. Work closely with Director of Manufacturing to identify and implement process and equipment improvements to enhance efficiency, quality and safety. Responsibility for monitoring and controlling spending in the Engineering R D and Process Engineering departments. Responsible to schedule and control overtime work for critical programs as needed. Work with Sr. Director, Operations, CHP Finance and Site Director to develop annual budget. Oversee cost reduction and/or productivity initiatives in the Engineering departments. Work with CHP Finance and consulting external partners to build and execute accurate and comprehensive Capital Request Proposals (CAR). Once approved, monitor daily progress and ensure adherence to that plan, making sure that timelines are held and approved spending budgets are not exceeded without prior approval. Maintain compliance with all regulatory requirements. Ensure Engineering personnel are properly trained on SOPs and production procedures, routinely auditing to ensure compliance. Perform investigations and take preventative and corrective action when areas of potential irregularity are identified. Actively participate on new product development teams. Ensure new products are introduced in an effective, safe and controlled manner and are produced on schedule and within quality specifications. Lead, mentor and develop direct reports and their subordinates. Provide training, leverage knowledge of laboratory and plant operations and promote a positive work environment. Ensure Master Batch Records are updated and maintained in an appropriate manner based on continuous improvement, CAPAs and audit responses and other key technical considerations. Represent the ERD and Process Engineering departments during business meetings as well as customer and regulatory audits. Demonstrate strong communication skills, technical ability to understand processes as well as a thorough understanding of plant operations. Application of key principles of chemical engineering to work within a matrix-based chemical development team to construct systems and design chemical processes that will efficiently support on-scale safe production of promising pharmaceutical candidates. Collaborate with project managers, process development chemists and analytical chemists to coordinate project activities as well as to develop safer and more robust processes for laboratory and plant production. Maintain current knowledge of state-of-the-art techniques for improving engineering principles related to organic chemistry, analytical chemistry, process development techniques and cGMP regulations. Knowledge of root cause/batch failure analysis. Ensure laboratory operations are conducted in a safe manner and are in compliance with all regulations at the corporate, federal, state and local levels. Responsible for aggressive and diligent leadership and management of internal programs according to established timelines. Recruit and hire new team members, as business growth dictates. Demonstrate effective communication skills, both internally and externally. Actively promote the results of ongoing projects within the group and to external clients. Qualifications/Skills Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential. Knowledge and experience in technologies such as continuous processing and flow chemistry is preferred. Ability to write comprehensive reports and draft, review and approve batch records and protocols. Proficiency with Microsoft software (SharePoint, Word / EXCEL / PowerPoint) is expected. Education, Experience & Licensing Requirements A minimum of B.S. in Chemical Engineering or related field with 7 years relevant experience in lab and/or plant environment, pharmaceutical experience preferred. Leadership experience preferred. Experience with continuous flow manufacturing and safety evaluation strongly preferred. Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (SharePoint, Word / EXCEL / PowerPoint) is expected. Some active work, exerting up to 25 pounds of force occasionally, and/or the amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed partly in an office setting and partly in a laboratory setting. Walking and standing are required regularly. Position also requires visual acuity, talking and fingering. #LI-SK1

Qualifications:

A minimum of B.S. in Chemical Engineering or related field with 7 years relevant experience in lab and/or plant environment, pharmaceutical experience preferred. Leadership experience preferred. Experience with continuous flow manufacturing and safety evaluation strongly preferred. Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (SharePoint, Word / EXCEL / PowerPoint) is expected.