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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 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

Position Summary:

The Manager in Drug Substance Manufacturing Operations works in a regulated cGMP environment within a Quality Management System and plays an important leadership role within the department. The manager supervises the chemical manufacturing operations as part of the DSDM management team. The manager is responsible for leading the manufacturing technical staff to enable the goals of the organization in Drug Substance Manufacturing with a focus on safety, quality, and right first-time metrics. The role is responsible for managing a team manufacturing specialists, execution of the production schedule, supervising manufacturing operations, equipment/suite readiness, staff training and ensuring compliance with safety and quality SOPs and policies throughout. This position will have supervisory responsibility for direct reports as assigned and will act in accordance and alignment with senior department management goals and mission.

Responsibilities

Key Job Responsibilities:

+ Supervises chemical manufacturing operations and proposes/implements actions under a continuous improvement and operational excellence environment in alignment with senior department management

+ Determines responsibilities of assigned staff including daily schedule completion

+ Supervisory responsibility includes performance management and career development of one or more direct reports as needed. May also direct others in task delegation in support of departmental senior management

+ Responsible for ensuring department and staff compliance with and enforcement of all cGMP SOP’s, Safety SOP’s, site-specific policies, and procedures

+ As needed, establish and maintain effective management systems to ensure success of the production schedule and supporting activities

+ Provide expert guidance and support to staff in problem solving technical issues in manufacturing operations, quality investigations and CAPA implementation

+ As part of the management team, responsible for safety incidents and quality deviations that occur and for their thorough investigation and timely reporting

+ May perform direct drug substance operations in execution of a manufacturing batch record under GMP or non-GMP conditions as needed.

+ Will contribute to department management of the GMP and non-GMP documentation processes including batch records and other quality documents used in the quality management system (change control, deviation, investigations, root cause analysis, CAPA, etc.) as needed or assigned.

+ Will work with senior department management contributing to departmental direction, policy, strategy, proposal writing, production schedule, equipment onboarding and qualification, audit support and departmental training as needed or assigned.

Qualifications/Skills

Required Knowledge/ Skills/Abilities

+ Extensive, expert understanding of phase appropriate cGMP requirements within pharmaceutical chemical manufacturing is required

+ Effective communication skills to thoroughly communicate strategy, mission and goals to staff while supporting a culture of learning, respect, professionalism and employee growth

+ Ability to effectively “manage up” to their manager and senior site leadership

Education, Experience & Licensing Requirements

Education & Experience

+ S. or M.S. in Chemistry or related field and 8+ years in cGMP chemical manufacturing environment with increasing responsibility

+ At least 3+ years supervisory experience with increasing responsibility

+ Extensive experience and understanding needed of cGMP requirements and phase appropriate quality management systems (MBRs, change control, deviations, investigations, CAPAs, etc.)

+ Knowledge of FDA, EU, and ICH requirements/guidelines and their implementation in the pharmaceutical industry

Supervision Received: General Supervision

+ Exercises independent judgment for obtaining results. May determine the methods and procedures on new assignments in alignment with senior department management expectations but still accomplishes goals within defined procedures and practices. Seeks management direction to ensure alignment and for problems of diverse and/or complex scope.

Travel: 0-5%

Physical Demands:

+ The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

+ While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 30 pounds and occasionally lift and/or move up to 50+ pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. The employee will often be required to wear various respirators and often use full face respirators with supplied air and must be physically fit to do so as required.

Environment and Protective Equipment:

+ The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

+ While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts and will work with a variety chemicals and solvents. The noise level in the work environment is usually under 60 db but can occasionally exceed that. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, ear protection, etc.

LIMITATIONS AND DISCLAIMER

The hiring range in Colorado for this position is $110,000 - $145,000; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity, and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.