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Direct Hire - Senior Associate, CMC Project Management
Ref No.: 18-31324
Location: Exton, Pennsylvania
Position Type:Contract
Start Date / End Date: 06/11/2018 to 09/10/2018
Job Title: Direct Hire - Senior Associate, CMC Project Management
Work Location: Exton, PA
Position Type: Permanent Direct Hire
Client: A Big Pharmaceutical Company

Job Description:

The primary focus of the Sr Associate, CMC Project Management will be to coordinate Drug Substance (DS) CMC activities for Client product candidates. This includes preparing and maintaining project schedules, budgets and resource requirements in support of activities in Process and Analytical Development, Process Transfer, Quality Control and Manufacturing as well as Regulatory Submissions. Project Management experience in the development and manufacturing of biologics is a requirement.

Job Responsibilities:
Prepare and maintain project schedules, budgets, and resource requirements in support of activities in process development, analytical development, process transfer, quality control and manufacturing activities.

Track expenditures to meet overall budget goals set by managers. Follows function's financial standards, guidelines and compliance requirements.

Provide support to Management in assessing resource needs to achieve timelines and program milestones. Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.

Tracks project metrics and consolidate documentation relative to project milestones. Work with the CMC Regulatory Department to develop timelines for regulatory filings (e.g., INDs and BLAs); communicate with CMC team to ensure all CMC sections of regulatory filings are of high quality and completed on-time.

Facilitate meetings (eg project team meetings, biopharmaceutical council meetings), and coordinate meeting logistics including scheduling meetings, sending out agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.

Support cross-function project management activities as assigned

Job Qualifications
3+ years of industry experience in the development of biologic products.
BS in Biological Science or Engineering is required
MS/PHD in Biological Science or Engineering, PMP is a plus
Strong Project Management experience managing CMC development programs for protein biologic programs.
Working knowledge of cGMPs and familiarity with relevant ICH Guidance documents
Experience in the generation of regulatory filings (INDs and BLAs).
Strong leadership and communication skills.

Must Haves:
- Experience in development of biologic drugs
- Scientific background (PMP a plus)
- Lab or manufacturing realm - no construction site
- Technical knowledge (GMP, ICH guidelines)
- Experience with protein biologics.

Interested candidates can share thier most updated resume at or they can reach out to me on #973-967-3412