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! Can we make this broader language, so it fits in all markets, e.g., 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

This position is responsible for implementing and enforcing the rules and regulations governing the manufacture, warehousing, processing, packaging, labeling, distribution, and reconciliation of all classes of controlled substances as stipulated by the Federal Drug Enforcement Agency, and relevant State and Regional agencies.

Responsibilities

• Complete all required periodic reports and inventories in a timely and accurate manner.

• Ensure the site is aligned to produce and ship scheduled substances through accurate completion of all required DEA documentation such as quota applications, inventories, destruction, shipping forms, etc.

• Plan and implement security procedures required for operational control at all stages of manufacturing, packaging, labeling, processing, warehousing, and distribution of Scheduled Drug Substances.

• Recognize the importance of documentation, as it relates to control of operations.

• Keep current on changes to DEA Schedules and policies

• Anticipate the expectations during a DEA inspection of the facility.

• Prepare written Standard Operating Procedures (SOPs) which will provide for 100% control of the schedule-identified substances operation.

• Collaborate with site engineering to assess all internal security systems and drive improvements as necessary

• Develop policies and procedures for inventory control and material handling that are consistent with company-wide policies and procedures

• Develop and maintain annual and monthly material plans in support of quota management and applicable to company-wide materials planning

• Perform capacity analysis related to the manufacture, storage, and shipment of scheduled drug products.

• Train, mentor, and develop staff

• Other projects as required and assigned

Education, Experience & Licensing Requirements

• Bachelor's Degree (four year college or university) or equivalent job experience.

• 5 years of experience working in a pharmaceutical environment in the security and DEA arena

• Understanding of the obligations imposed upon all DEA registrants to compliment the basic requirements of FDA Current Good Manufacturing Practices (CGMPs

Physical Requirements:

• Must be able to move about the facility

• Must be able to remain sedentary for periods of time

• Required to wear personal protective equipment

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.