Biotech & Pharma H-1B Sponsorship Jobs in Kentucky

INTRODUCTION

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

JOB TITLE

PROJECT MANAGER

JOB OVERVIEW

Reporting to the Director of Project Management, the Project Manager is the primary and critical interface with clients regarding both existing and potential development projects and has cross-functional responsibility for facilitating and managing completion of all required elements of the project strategy.

REPORTING STRUCTURE

This position reports to the Director of Project Management.

KEY RESPONSIBILITIES:

• Serve as the main point of contact for internal and external clients throughout the manufacturing process
• Lead role in determining specific client requirements
• Ensure that client expectations are managed and met
• Negotiate acceptance of scope changes with client
• Manage project scope, critical path, timeline and budget of multiple complex projects simultaneously
• Manage communications such as conference calls and meetings with clients to ensure a positive relationship
• Maintain detailed meeting minutes for internal and external use and send out as appropriate
• Establish practical, achievable, realistic timelines/goals with internal and external project teams
• Identify scope creep and create scope change document with input from appropriate functional groups including business development
• Responsible for identifying potential problems in meeting commitments
• Resolve potential shortfalls in meeting commitments first by working internally with Piramal Pharma Solutions team so commitment can be made, or if it not feasible, contacting the client as soon as possible to renegotiate a new commitment that they can accept
• Develop project risk management plan
• Coordinate with Finance to obtain project financials to hold project close-out meeting
• Establish and report on essential project metrics (such as variance) and elevate issues/risks to senior and executive management
• Manage revenue forecast for projects
• Participate in revenue notification process and complete invoice notifications as required
• Manage and communicate client needs and expectations to project team
• Work with Piramal Pharma Solutions employees to ensure that commitments made to clients are realistic and achievable
• Coordinate with business development and/or client to ensure appropriate information and materials are provided to facilitate kick-off of project
• Effectively schedule, facilitate and manage team meetings and ensure that proper communication regarding the project is appropriately elevated and distributed
• Influence/motivate team members to enact project plans and achieve goals
• Mentor team members and encourage positive team atmosphere
• Lead projects in alignment with Piramal Pharma Solutions - Lexington/Policies and FDA guidelines
• Assist in department standardization
• Provide training to project team members as needed

QUALIFICATIONS

• Bachelor's Degree in applicable scientific field required, advanced degree preferred
• One to three years of Project Management experience desired
• Minimum two (2) years of previous pharmaceutical industry experience desired, contract manufacturing or contract research organization experience strongly preferred
• Good working knowledge of cGMP Guidelines and FDA regulations as well as an ability to understand company policies, SOPs, and Safety/OSHA policies
• Proficient in use of common office software including SmartSheet (or equivalent alternate PM software), Excel, Word, and Power Point
• Can demonstrate understanding of project management practices; including project initiating, planning, execution, monitoring/controlling, and closeout
• Requires excellent written and verbal communication skills. Must be proactive and able to engage effectively with multiple stakeholders
• Proven ability to meet deadlines and handle stressful situations effectively
• Detail oriented

LOCATION:

Location: Lexington