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Project Manager – Controlled Substances

Location

Charles City, IA, USA

Department

Manufacturing / Operations

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Project Manager – Control Substances is the technical liaison with commercial generic controlled substance (CS) customers and coordinates activities for Amphetamines, Fentanyl, and other identified generic controlled substance products.  This position has frequent interactions with customers, sales representatives, Production, Quality Assurance and Regulatory Affairs to ensure customer needs are met while maintaining compliance with regulatory requirements and ensuring efficient product manufacturing.

 

Responsibilities

 

  • Lead or participate in investigation teams as needed when deviations or rejects occur and prepare the report of findings
  • Provide a high level of customer interaction and technical support
  • Maintain a high level of positive and effective communication with customers, team members, management and sales representatives
  • Serve as resource for Sales, Senior Management and Customer Service regarding allotment and customer feedback
  • Organize and coordinate multi-disciplinary teams for customer driven initiatives
  • Coordinate with the Production Planner to maintain the long term production schedule balancing customer need, efficiency and inventory
  • Estimate and update product costs as necessary
  • Monitor compliance with controlled substance manufacturing requirements and provide assistance to Regulatory Affairs for the purpose of inventory tracking and quota issues
  • Assist with production management responsibilities for batch record reviews, investigations, and TrackWise approvals

 

All employees are required to adhere to OSHA, EPA, DEA, 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

 

  • A minimum of a Bachelor’s degree in Chemistry or Chemical Engineering 
  • 5 or more years of experience in a pharmaceutical manufacturing organization
  • Experience with overall management and responsibility for project teams
  • Familiarity with cGMP regulations
  • Direct customer contact and relationship management
  • General knowledge of chemical operations equipment and manufacturing operations
  • Skills managing multi-disciplinary teams
  • Understanding of business plans and financial impacts
  • Good project management skills required. High attention to detail
  • Windows based computer knowledge
  • Remote possibility a couple of days a week – primarily need to onsite.

 

GENEROUS RELOCATION ASSISTANCE!!
#1 small molecule API Contract Manufacturing Organization (CMO) in the USA
Double digit sales growth each of the last 5 years
Recent $75 million expansion of our large-scale API facility
Winner of 30 CMO Leadership Awards in 2017
IOWA – Ranked #1 state for best place to live by US News and World Report
Leading Western supplier of generic APIs including ADHD and other controlled substances