Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. 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 healthcare, life insurance, planning for retirement, 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 primary purpose of this position is to lead and manage the Process Engineering team, ensuring that all engineering activities align with Cambrex’s strategic goals and comply with regulatory requirements, including those of the DEA, EPA, FDA, and OSHA. The Associate Director, Process Engineering will drive process improvements, optimize manufacturing processes, and support the scale-up of new products. This role requires strong technical expertise, leadership skills, and the ability to collaborate across departments to ensure that all engineering projects meet customer and business demands. Responsibilities + Process Engineering Management: + Provide daily oversight and management of the Process Engineering team, ensuring alignment with production schedules and company goals. + Lead the development and implementation of engineering solutions to improve process efficiency, yield, and product quality. + Ensure that all process engineering activities comply with cGMP, SOPs, and regulatory standards. + Technical Leadership: + Oversee the scale-up of new products from R&D to full-scale production, ensuring processes are safe, efficient, and compliant. + Provide technical guidance and support to engineers and production teams to resolve complex operational issues. + Identify and implement process improvements, focusing on cost reduction, energy efficiency, and waste minimization. + Cross-Departmental Collaboration: + Work closely with Production, Quality, R&D, and other departments to ensure that engineering projects meet or exceed customer expectations. + Participate in cross-functional teams for new product development, providing process engineering expertise to ensure successful product launches. + Regulatory Compliance: + Ensure that all engineering activities meet regulatory requirements, including DEA, FDA, EPA, and OSHA regulations. + Lead internal audits and support external regulatory inspections related to process engineering. + Team Development: + Mentor and develop the Process Engineering team, fostering a culture of continuous improvement and technical excellence. + Utilize performance management tools to support the professional growth of team members. + Budget and Resource Management: + Manage the budget for the Process Engineering department, ensuring cost-effective use of resources. + Monitor and control spending within the department, ensuring alignment with financial goals. + Project Management: + Lead capital projects related to process improvements, ensuring projects are completed on time, within scope, and within budget. + Provide technical leadership in evaluating and selecting process technologies and equipment. Qualifications/Skills + Strong technical understanding of chemical processing, manufacturing operations, and regulatory requirements. + Experience with cGMP, DEA, FDA, EPA, and OSHA regulations. + Proven ability to lead and develop high-performing teams. + Excellent written and oral communication skills, with the ability to effectively communicate complex technical concepts. + Experience in Lean Six Sigma or Six Sigma, with Green Belt or Black Belt certification preferred. + Strong project management skills, with experience managing capital projects. + Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint. + Ability to obtain DEA clearance for drug manufacturing. Education, Experience & Licensing Requirements BS in Chemical Engineering or related field required; MS or MBA preferred. Ten or more years of experience in process engineering within a chemical or pharmaceutical manufacturing environment, with at least five years in a leadership role. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.