Associate Director, Capital Projects

4 days ago

Saint Charles, Missouri, United States Cambrex Full time
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 environmentstrengthen 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 Associate Director of Capital Projects is responsible for the strategic planning, execution, and oversight of capital projects at the CDMO site. This role provides leadership for project management, engineering design, procurement, construction, and validation of facilities, utilities, and manufacturing equipment. The position ensures that all projects meet regulatory compliance requirements (cGMP, FDA, OSHA), are delivered on time and within budget, and align with business goals and operational excellence initiatives.

Responsibilities

Lead the planning and execution of site capital projects from concept through handover, ensuring quality, safety, cost, and schedule objectives are met.Develop and manage multi-million-dollar capital budgets and resource plans in collaboration with site leadership and global engineering teams.Oversee cross-functional teams including engineering, validation, quality, procurement, and operations personnel to ensure project alignment with site needs.Act as the primary liaison with external architects, engineers, contractors, and regulatory authorities for capital initiatives.Ensure all projects comply with GMP, environmental, health and safety (EHS), and regulatory requirements.Provide technical leadership in facility design, utility systems (HVAC, WFI, clean steam), and process equipment implementation.Drive risk management strategies, contingency planning, and change control processes throughout project lifecycles.Prepare and present project updates, metrics, and risk assessments to senior management and stakeholders.Mentor and develop junior and experienced project engineers to support a high-performance project team.

All employees are required to adhere to OSHA, DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications/Skills

Strong knowledge of GMP regulations, validation practices, and pharmaceutical production processes.Proficient in project management tools (MS Project, Primavera, etc.) and capital planning software.Excellent communication, negotiation, and leadership skills.Ability to work collaboratively in a fast-paced, matrixed environment.Education, Experience & Licensing Requirements

Bachelor's degree in Engineering, Construction Management, or a related field required; Master's degree preferred.Minimum of 10 years of experience in capital project execution within the pharmaceutical, biotech, or CDMO industry.At least 5 years in a leadership or managerial capacity overseeing cross-functional project teams.Demonstrated experience managing complex capital projects ($10M+) in a regulated manufacturing environment.

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.

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