Project Manager

piramalpharma; Sellersville (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Project Manager to serve as the primary interface with clients and oversee cross-functional project delivery in Sellersville. The role requires managing scope, timelines, budgets, and critical path across multiple complex projects while maintaining strong client relationships.

The successful candidate will bring at least 5 years of PM experience in the pharmaceutical sector, solid knowledge of cGMP/FDA guidelines, and proficiency with SmartSheet and MS

Qualifications

• Minimum 5 years of Project Management experience.
• Minimum 3 years of Pharmaceutical industry experience; contract manufacturing or CRO preferred.
• Bachelor's degree in scientific field; advanced degree preferred.
• Good working knowledge of cGMP Guidelines and FDA regulations, SOPs and Safety/OSHA policies.
• Proficient in SmartSheet, MS Projects (or equivalent PM software), Excel, Word and PowerPoint.
• PMP certification is strongly preferred.

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.
• Coordinate with client communications and maintain detailed meeting minutes.
• Establish realistic timelines/goals with project teams.
• Identify scope creep and create scope change documents with input from business development.
• Resolve potential shortfalls in meeting commitments by coordinating with Piramal teams or renegotiating with clients.
• Develop project risk management plans and report essential metrics.
• Coordinate with Finance to obtain project financials for close-out meetings.
• Manage revenue forecast and participate in invoice notifications as required.
• Mentor team members and encourage a positive team atmosphere.
• Lead projects in alignment with Piramal Pharma Solutions - Sellersville/Policies and FDA guidelines.

Skills

Project management

Education

Bachelor's degree in scientific field

Advanced degree preferred

Tools

SmartSheet

MS Projects

Excel

Word

PowerPoint

Job description

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Division

Piramal Pharma Solutions 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

PROJECT MANAGER 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. 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 (Shimadzu Technology)
• PH meter
• Prep HPLC handling, 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