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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.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Job Description

The Project Manager is the primary and critical interface with clients regarding both existing and potential projects. They have cross-functional responsibility for facilitating and managing completion of all required elements of the project strategy.

PRIMARY 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 commitment.
• 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 - Sellersville/Policies and FDA guidelines.
• Assist in department standardization
• Provide training/mentorship to project team members as needed
• Other duties as deemed necessary

Responsibilities

LC-MS/HPLC Method Development

• Analytical Method Development of newly developed products independently.
• Interpretation of IR & NMR Spectra.
• Isolation and characterization of Impurities.
• Responsible for troubleshooting of instruments in case of problems.
• Impurity Profiling of Drug substances.
• Calibration of Analytical Instruments.
• HPLC(ShimadzuTechnology)
• PHmeter
• Prep HPLChandling, Supercritical Fluid Chromatography

QUALIFICATIONS

• Minimum 5 years of Project Management experience
• Minimum 3 years of Pharmaceutical industry experience. Contract manufacturing or contract research organization is preferred
• Bachelor's degree in scientific field, Advanced degree 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 the use of common office software including SmartSheet, MS Projects (or equivalent alternate PM software), Excel, Word, and Power Point
• Proficient understanding of project management practices; including project initiating, planning, execution, monitoring/controlling, and closeout
• PMP certification is strongly preferred
• Strong written and oral communication skills
• Ability to build client relationship
• Showcase Leadership skills
• Strong stakeholder management and conflict management abilities
• Exceptional attention to detail
• Strong sense of urgency and work ethic

WORK ENVIRONMENT

• Ability to work in a high demand setting
• Ability to identify and organize resources
• Ability to work on-site full time
• Ability to maintain professional relationships while providing excellent customer service and client management

NOTE: The above statements are intended to describe the general nature of work performed by the Project Manager. These statements are not to be construed as an exhaustive list of all responsibilities, tasks, and skills required of an employee in this position.
Piramal Pharma Solutions reserves the right to require that other tasks be performed when warranted (for example, by emergencies, changes in personnel or workload, corporate reorganization, or technical development). PPS also reserves the right to revise this position description.