Position: Analytical Project Manager

Location: King of Prussia (Hybrid)

Company: SK Pharmteco

The Analytical Project Manager (APM) is responsible for the scheduling and financial reporting

and billing of Analytical work scopes within client programs, related to cell and gene therapy CMC

programs with significant unmet medical need or in rare diseases. In this role, the Analytical

Project Manager partners closely with the Scientific Program Leader and Project Manager on one

or multiple client programs to enable the overall program team to be successful in meeting and

exceeding our client requirements, thus ultimately serving our patients.

Types of client programs include 1) CDMO programs from development to GMP manufacturing

and testing, and 2) External Testing Only programs. Both cover all clinical and commercial

phases from Pre-Clinical to Post-Launch Life Cycle Management.

The Analytical Project Manager operates End-to-End from Project Initiation to Tech Transfer or

Development of Client Methods to GMP Testing & Stability, contributing to the strategy creation and creating a plan to track each method and deliverable through out the project.

The APM also leads the internal and joint Analytical Subteam meetings, making the scope and

plan clear, and identifying risks and obstacles such that the team or management can

debottleneck and resolve. Needs to be client facing, organized, efficient, and driven to succeed.

Generally required to perform a wide variety of tasks on a daily basis.

Responsibilities:

• Scheduling; Organizing Program Information, Budget Management, Scope Change Management, Progress Monitoring; Updating team members and partners; Managing information flow
• Works integrally with the Analytical SME’s, Analytical Development Head and GMP Testing Head in developing schedules and scenarios to meet critical milestones. .
• Is client interfacing serving as the leader of joint Analytical Subteam meeting and as a Core Team Member on the Joint Core Team. Connects internal SMEs to client SME’s as needed.
• Works integrally with the Program Leader, Finance and Business Development from Proposal to Program Initiation to Program Close Out in regards to Analytical timelines and budget management.

Skills:

• Communication: Able to make the complex simple and appropriate for the audience level (e.g. how to simplify schedules to show the critical path, bottle necks, and risks; how to simplify the financial reporting to a one-pager capable of showing the overall financial health of a project automating as much of the reporting as possible with potentially more detailed reporting when interfacing with Finance).
• Problem-solving: Projects rarely go exactly as planned, and the best candidates pro-actively work with team members and the Program Leader to show areas of timeline or budget risk via data and visuals, enabling the team to proactively mitigate risks. Understands the fundamentals of analytical methods and when to pull in certain SME’s to resolve issues.
• Highly Organized: Able to manage lots of moving parts and keep information organized and accessible to both internal and external team members electronically, allowing the Program Leader and team to stay aligned to overall program decisions, timeline commitments, and actions.
• Budgeting: Financial project acumen that allows the candidate to understand and prepare financial reports, and operate within SAP to assure timing billing and change order tracking for Testing Only Programs. For CDMO Programs, provides this input to the Project Manager.
• Team Player: Overall good cross-functional team player able to partner Analytical Development, GMP Testing, Stability, Sample Management, and Supply Chain for Materials, and clients on the Tech Transfer or development of methods. Lives into our culture where the “We is more important than the I”.
• Technically Knowledgeable: Familiar with Analytical methods, laboratory operations, and clinical phase appropriate development. Able to use laboratory systems such as LIMS, to collect and keep data organized both for internal team members and the client.

Requirements:

• Bachelor’s degree in a scientific or engineering discipline required.
• 3 to 15 years of related pharmaceutical or biotech experience required, including relevant experience in analytical labs.
• 2 years of project management experience managing multi-disciplinary project teams or Analytical teams. CDMO experience preferred.
• Advanced formal training, degree or certification(s) preferred
• Excellent leadership, written and verbal communication skills and ability to influence others
• Excellent critical thinking and problem-solving skills
• Detailed and results orientated
• Excellent negotiation and facilitation skills, with strong customer-service focus
• Able to professionally handle multiple and sometimes competing priorities
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment
• Ability to lead multi-disciplinary project teams
• Strong understanding of pharmaceutical product development and manufacturing
• Strong knowledge of FDA regulation/ICH guidelines, U.S. drug development process and project management practices
• Proficiency in Microsoft Office programs including Word, Excel and MS Project
• Proficiency with ERP, CRM, and Documentation Systems
• Ensures accuracy and relevance of assigned training curriculum
• Drives timely completion of training for employees to meet regulatory requirements
• Performance management, coaching, mentorship, and development of employees