Senior Project Manager New Products (Leadville)

CordenPharma in Leadville, CO

  • Type: Full Time
position filled

CordenPharma

Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

OUR MISSION

Support our customers, leading pharmaceutical and biotechnology companies, in full and on time (DIFOT) with products and services. Our ultimate stakeholders and beneficiaries are naturally the patients in critical need of the sophisticated medications we manufacture.

We should never forget that the work we all do as an organization is critical to patients and ultimately improves peoples lives. There lies our right for existence, challenge, opportunity and motivation that should drive each of us individually at your respective sites and us together company-wide across the entire network.

SUMMARY

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. Additionally, synergistically perform the role and duties of Distinguished Chemical Process Engineer on new and strategic business opportunities, as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Project Manager for New Product Introduction

  • > > Drive adherence to Cordens 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 and customer project manager to ensure mutual agreement of contract scope and schedule.
  • > > 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 RFPs. Lead preparation of Proposals for scope additions to existing Development Projects.
  • Distinguished Chemical Process Engineer
    As needed, fulfill the role and duties of Distinguished Chemical Process Engineer in support of Development Projects and business needs, including but not limited to:

  • > > Serve as technical advisor to Development Project teams, manufacturing, and management; interacts with management in developing technical vision and goals, business strategies, and in assessing new business opportunities.
  • > > 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. Author operating procedures, SOPs, guidelines, PSI packages, and process models and leads or participates in the assembly of technology transfer packages.
  • > > Identify, develop and implement innovative processes, process improvements, optimization and technology that: improve yield, cycle times and product quality; resolve or prevent environmental, health and safety impacts; and improve process robustness.
  • > > Provide technical leadership, bringing together stake holders and subject matter experts as needed to generate change and facilitate problem resolution.
  • SAFETY & ENVIRONMENTAL RESPONSIBILITIES

    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.

    QUALIFICATIONS

    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.

    EDUCATION and/or EXPERIENCE

    Minimum BS in Chemistry or Chemical Engineering. Approximately twenty (20) years experience in Pharma industry, with at least 5 years in Project Management and external customer communications, and fifteen (15) years of demonstrated success in process engineering in an API manufacturing environment.

    LANGUAGE SKILLS

    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.

    MATHEMATICAL SKILLS

    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.

    REASONING ABILITY

    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.

    CERTIFICATES, LICENSES, REGISTRATIONS

    None

    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 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.

    WORK ENVIRONMENT

    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.

    CORE COMPETENCIES

    These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

  • > > 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.
  • > > Technical understanding of organic chemistry.
  • > > Broad, demonstrated expertise in chemical engineering and API process improvement.
  • > > Thorough, demonstrated knowledge of pilot through manufacturing scale unit operations, scale-up, and plant design considerations.
  • SALARY

    This is an exempt position. Salary based upon the successful candidates qualifications and level of experience.


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