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Corden Pharma - A Full-Service CDMO · 6 days ago

Sr. Project Manager

Boulder, CO

Full-time

Onsite

Senior Level, Lead/Staff

$125K/yr - $165K/yr

10+ years exp

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients. The Sr. Project Manager will manage resources and cross-functional efforts to achieve project objectives, while providing leadership and mentoring to other Project Managers as assigned.

BiotechnologyManufacturingPharmaceutical

Responsibilities

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 vs. 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 goal

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

Lead and coordinate the preparation of Proposals for New Business RFPs. Lead preparation of Proposals for scope additions to existing Development Projects

As needed, provide leadership and mentoring to two to three Project Managers

Provide guidance regarding business processes, communication, issue resolution, and other key topics to assigned Project Managers

Act as a sounding board and provide feedback to assigned Project Managers

Assist in the onboarding and professional development activities. Work with the Director of PMO to provide development paths

Provide technical judgment, bringing together stakeholders and subject matter experts as needed to generate change and facilitate problem resolution

Provides guidance and leadership where appropriate. Participates in the expense budget process by developing, tracking, and reporting data related to teams and projects

Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts

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 their knowledge, training, ability, and experience

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company

CGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado

Qualification

API DevelopmentCGMP KnowledgeProject ManagementChemical EngineeringCustomer CommunicationMS ProjectLeadership SkillsOrganizational SkillsNegotiation SkillsTechnical Writing

Required

A BS in Chemistry, Chemical Engineering, or other technical degree

Ten (10) years' experience in Pharma Industry, with 5 years in Project Management and external customer communications

5 years of demonstrated success in an API Development and Manufacturing environment, or equivalent combination of education and experience in API Development and 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 board 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

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