Scientific Program Leader

King of Prussia, PA, United States

Position:

Scientific Program Leader

Location:

King of Prussia, PA (Hybrid)

Company:

SK Pharmteco

The Scientific Program Leader will lead and drive the execution of all stages of client programs from initiation of the partnership, process development, technology transfer, cGMP manufacturing to IND and/or BLA. Program Leaders will be responsible for partnering with the client and SKPT team to create a scientifically sound strategy that allows the team to execute right the first time, in accordance with each clients specific risk tolerance. The Program Leader will then work with the team to translate the strategy to a project plan, then lead the team in the execution of said strategy in partnership with the client to achieve key client milestones.

The position requires a highly motivated individual able to progress programs forward in a matrix team environment and serve as the clients advocate within the CDMO (Contract Development and

Manufacturing Organization) business while also successfully advocating for SKPT to execute with speed without compromising quality. Candidates must have demonstrated success managing complex programs within the biotherapeutics industry, preferably for advanced therapies (i.e. cell and gene therapies).

In addition, they must be able to drive programs forward and work collaboratively with both clients and colleagues in an environment that requires collaborative decision making. The position levels are typically Associate Director to Director and fit to the candidate based on experience and the business based on need.

Responsibilities:

Be results-driven and reliably meet and exceed client expectations by supporting the program needs of CDMO partners and clients.

Lead all stages of projects within a matrix organization. Specifically, this includes the introduction of new products into the facility, supporting process development, analytical development, technology transfer of new products to cGMP manufacturing through all stages of clinical development through to commercial.

Effectively resolve project team issues and facilitate decision making within the team resolving conflicts where necessary.

Track and manage the financial aspects of the project including milestone payments, pass through costs and FTE estimates to ensure client programs progress on time and on budget.

Manage progress, issues, and risks of programs of substantial complexity and scale.

Manage all client interactions, including maintaining and a regular cadence of project meetings, preparing meeting minutes, maintaining an action tracker, and effectively following up with internal and external team members to progress the program and closeout of actions.

Ensure efficient and effective communications of program/project related information to all levels within the organization and to clients, building trust, transparency and partnerships.

Develop, improve, and implement program and project management tools and templates for use by the program teams.

Support department and individual goals and key performance indicators in alignment with SKPT operational and organizational goals.

Bring an entrepreneurial mindset and be ready to contribute to the high growth of SKPT by living into the SKPT mission, vision and values.

Skills:

Communication:

Able to make the complex simple and appropriate for the audience level. Able to balance advocating for the client and advocating for SKPT. Able to communicate to senior leadership in a way that elicits action when appropriate.

Problem-solving:

Projects rarely go exactly as planned, and the best candidates pro- actively work with team members to show areas of timeline or budget risk via data and visuals, enabling the team to proactively mitigate risks. Understands the fundamentals of CMC development and when to pull in certain SMEs 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 internal and client joint team to stay aligned to the overall program decisions, timeline commitments, and actions.

Budgeting:

Financial project acumen to understand and drive the team towards on-time achievement of billing milestones. Collaborates well with Finance colleagues. For CDMO Programs, provides this input to the Project Manager.

Leader & Team Player:

Overall good cross-functional leader and team player able to partner with Process Development, Tech Transfer, MSAT, GMP Manufacturing, Quality, Analytical Development; GMP Testing and Supply Chain for Materials. Overall good team player able to partner with fellow Program Leaders and Project Managers to create a learning environment. Lives in the culture of We is more important than the I.

Technically Knowledgeable:

Familiar with Biologics CMC Development to Clinical and Commercial Manufacturing and Testing. Cell and Gene Therapy specific knowledge is a preferred.

Requirements:

Bachelors Degree in a relevant scientific or engineering discipline. Graduate degree is a plus.

Minimum 10 years related experience in the biopharmaceutical industry, with an understanding of biopharmaceutical CMC development and manufacturing. Experience with CDMOs either as a client or CDMO employee is preferred.

3-5 years experience in a Program Team Leadership or Program Management role responsible for the client or internal programs (experience in a contract manufacturing organization is a plus) and a strong understanding of CMC.

Possess working knowledge of biopharmaceutical product development lifecycles with experience managing process development and/or clinical or commercial manufacturing programs. Knowledge of cGMPs, regulatory environment, and biopharmaceutical manufacturing.

Significant experience leading cross-functional teams to deliver on-time, on-budget, within scope and in compliance with all quality and regulatory requirements.

Equivalent combinations of education, training, and relevant work experience will be considered.

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

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