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Project Manager

XGen Pharmaceuticals DJB Inc

This is a Full-time position in Atlanta, GA posted March 18, 2021.

Job Title:    Project Manager 

Department:    Project Management

Supervisor Title:    Manager or Project Management 

Revision Date:     September 1, 2020

GENERAL RESPONSIBILITIES

  The primary role of Project Manager is the comprehensive direction and oversite of new product development and/or modifications of existing products with focus on excellence in execution.  Working within well-defined processes and in compliance with cGMP standards and industry best practices, the Project Manager will be responsible for identifying resources, troubleshooting of challenges, establishing positive working relationships with CMOs , suppliers and industry specialists, while leading multi-disciplinary teams, assigning tasks, evaluating risk and determining target completion dates for successful and timely completion of projects assigned.  The goal: delivering commercially viable, safe and effective product opportunities to market on time and on budget. 

PRIMARY ACTIVITIES

•    Supports XGen DJB’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.

•    Manage assigned projects within the established project management structure, working within a framework of industry best practices. in support of successful portfolio growth and sustainability. 

•    Identify and assign resources, establish criteria of acceptability for task completion; prioritize project tasks, monitor and report on project status, including contributing data and reports directed to senior management and collaboration partners. 

•    While seeking input from Subject Matter Experts and management, helps to identify and evaluate project risk, and develop and implement risk mitigation strategies in the team environment.

•    Establish and maintain project budgets to reach revenue, cost and profit targets.

•    Process financial instruments (Purchase Orders and Invoices) to ensure accurate and prompt payment of vendors through established accounting systems, i.e. Concur, QaD, others.

•    Actively contribute to the drafting and review of essential documents, including revisions or amendments to Project Charters, Scope of Work Documents, and protocols as assigned. Ensure that document processes are followed in the development of any collateral materials. 

•    Demonstrate on a continuous basis artful, respectful and effective communication with all stakeholders in the establishment of positive working relationships.

•     Establish discipline in the ongoing monitoring of industry / environmental influences that could have impact on project outcomes, both positive and negative. Escalate and present findings to management and team.

•    Facilitate team and supplier meetings, including site visits during key development and manufacturing milestones.  

•    Coordinate with Product Management / Commercial support to ensure a flawless and on-time product launch into the intended commercial market(s).

•    Represent XGen DJB at key assigned industry conferences, training and symposia. 

•    Performs other related duties as assigned or directed

LEADERSHIP BEHAVIORS AND COMPETENCIES

•    Results Orientated – Able to prioritize and focus on critical objectives; Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy. 

•    Collaboration – Builds partnerships and works collaboratively with others to meet shared objectives. 

•    Ensures Accountability – Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures. 

•    Communicates Effectively – Develops and delivers communications which convey a clear understanding of the unique needs of different audiences 

•    Strategic Thinking – Seeks to understand and assesses the impact of challenging situations on project execution, using the tools and team available to drive towards the best possible project outcome.  

•    Interpersonal Effectiveness – Credible, trustworthy and empathetic team leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people. 

•    Agility and Flexibility – Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear. 

•    Versatility – Able to work in a variety of roles and settings, with a diverse group of people and/or functions. 

HIGH ETHICAL STANDARDS AND INTEGRITY

BASIC QUALIFICATIONS

Education: Bachelor’s Degree in discipline related to Pharmacology, Life and Health Sciences, Laboratory Science (Chemistry, Biology, or Engineering); Advanced degree desirable

Training (licenses, programs, or certificates): Project Management Professional (PMP) Preferred

Skills: 

•    Pharmaceutical Product Development

•    Regulatory Compliance

•    GMP Compliance 

•    Pharmaceutical manufacturing processes 

•    Manufacturing Process Qualification

•    Analytical Method Qualification

•    Quality Assurance / Quality Control

•    Change Management

•    Change Control

•    Pharmaceutical Production

•    Cross Functional Team

Basic/Moderate/Proficient reading, writing, grammar, and mathematics and business management skills 

Basic/Moderate/Proficient interpersonal relations and communication skills, including use of English language

 Basic/Moderate/Proficient computer skills including Microsoft Office, Go To Meeting, Project Management Software (MS Project, SmartSheet, Etc.)

Travel:  Up to 40% to include both domestic and international travel

Indirect Management (standard language)

Experience:

Minimum: 5 Years

Proficient: 10 Years

Equipment:

Operate standard office equipment.

OTHER REQUIREMENTS

Physical Requirements:

Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds.

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