Project Manager, Oligonucleotides
Job # 1723
CordenPharma Colorado

Manage resources and cross-functional efforts to successfully achieve customer deliverables and project objectives for contracted development and technical transfer of active pharmaceutical ingredients at Corden Pharma Colorado.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Drive adherence to Corden’s contractual commitments: develop project plan including resources, timing, milestones, and deliverables. Track, monitor, and report key performance metrics including expenditures v. budget.
  • Manage and control multiple projects to meet objectives.
  • Act as a liaison between Corden Pharma Colorado and customer project manager to ensure mutual agreement of contract scope and schedule.  Execute contract change management.
  • Monitor trends and drive continuous improvement of the project management process.
  • Develop and distribute periodic reports on project performance, issues, risks, and schedules of key activities, events, or milestones.
  • Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect project performance goals.
  • Ensure risk assessments and appropriate risk mitigation plans are established for projects at every phase of the contract.
  • Collaborate with R&D, Quality, and Operations to understand critical to quality product requirements.
  • Assist with the preparation of Proposals for New Business RFP’s.  Lead preparation of Proposals for scope additions to existing Development Projects.
  • Review the status of process knowledge, identify gaps and work to improve the overall understanding of processes and the criticality of process parameters.  Ensure that this knowledge is widely available through appropriate documentation of lab, campaign, process investigation, process optimization, and process fit reports.
  • Provide technical leadership, bringing together stake holders and subject matter experts as needed to generate change and facilitate problem resolution

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace.  Each employee is expected to perform their job duties in a safe manner utilizing all of their knowledge, training, ability and experience. 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Minimum BS in Chemistry or Chemical Engineering.  Approximately fifteen (15) years’ experience in Pharma industry, with at least 5 years in Project Management and external customer communications in a pharmaceutical manufacturing environment.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, political and legal documents.  Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Project Management Professional Certification preferred.
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 is regularly required to talk or hear.  The employee is occasionally required to stand; walk; sit; works with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
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 is occasionally exposed to moving mechanical parts, fumes or airborne particles and noise typical of an office environment. 

  • Working knowledge of biotech/pharma manufacturing operations, product and process development, and supply chain operations in a cGMP-regulated environment
  • Demonstrated outstanding customer service skills
  • Excellent verbal, written and interpersonal communication skills
  • Good business negotiation skills
  • Excellent leadership and influencing skills in diverse team environment
  • Excellent organizational skills.  Capable of handling multiple tasks / projects.
  • PC skills to include MS Project, Excel, and Word
  • Broad, demonstrated expertise and experience in pharmaceutical (API) processes
  • Thorough, demonstrated knowledge of pilot through manufacturing scale unit operations, scale-up, and plant design considerations 

This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
Please refer to: Job #1723 – Project Manager, Oligonucleotides
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