Program/Project Manager
Pharmaceutical Product Development, LLC
PA
hace 32 días

EXPECT MORE FROM YOUR CAREER

EXPECT PPD

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP.

PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-

time benefits / advantages of being a part of PPD.

As a Program / Project manager in this role you will provide operational support for programs, initiatives and departmental activities for Biologics Development within Technical Operations at the client site in the Philadelphia Office.

The incumbent will be part of global team working in biologics development. You will work closely with the functional area team members to ensure successful completion of the project deliverables.

In addition, you will participate in process administration and improvements with Technical Operations.

Responsiblities

  • Manage assigned projects in a global, cross-functional team setting
  • Work jointly with CMC Team Lead to guide and motivate project team members
  • Establish and maintain comprehensive project plans, integrated timelines and budgets
  • Work jointly with CMC Team Lead to set agendas and guide the team
  • Facilitate cross-functional team activities to achieve successful project completion within scope, on schedule and within budget constraints
  • Facilitate meetings, provide meeting minutes and drive action item follow-up
  • Identify project risks and prepare mitigation and contingency plans
  • Create and maintain consistent project documentation including detailed budgets
  • Ensure team conflicts are resolved in a professional and timely manner
  • Provide project management support for organizational projects if requested
  • Identify and implement improvements to project management processes and infrastructure
  • Education and Experience

  • B.S. / B.A. in Chemistry, or related field with 4 years lab related experience in the pharmaceutical and / or biotech industries or
  • M.S. in Chemistry, or related field with 3 years lab related experience in the pharmaceutical and / or biotech industries
  • Ph.D. in Chemistry, or related field with 2 years lab related experience in the pharmaceutical and / or biotech industries
  • Including 1-2 years experience working with single or multiple lab studies to include the areas of stability, QC, and method development and validation
  • In some cases a combination of education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job accountabilities satisfactorily.
  • Knowledge, Skills and Abilities

  • Knowledge and proficiency in analytical chemistry technologies associated with cGMP studies.
  • Efficient in scheduling meetings, managing calendars and activities
  • Ability to work effectively in a matrix organization
  • Ability to collate and present resource utilizations
  • Collate and manage budgetary details
  • Experience with managing contracts and partners
  • Knowledge and understanding of all aspects of lab study project management to include the areas of stability, QC and method development and validation
  • Excellent problem solving, judgment and decision-making skills.
  • Effective oral and written communication skills.
  • Proven organizational and negotiation skills.
  • Understanding of basic budgeting and forecasting terms and definitions
  • Full understanding of cGMP requirements, ICH guidelines, USP requirements and FDA guidance
  • Ability to multi-task and effectively prioritize workload
  • Detail oriented
  • Excellent computer skills
  • Possesses good interpersonal skills and positive attitude.
  • PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

    Primary Location

  • North America-United States-Pennsylvania-FSP2 Philadelphia, PA
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