Project Manager II- Labs
Company: Alcami Corporation
Posted on: October 18, 2020
Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing
organization (CDMO). We are a team of dynamic individuals committed
to developing life-saving drugs around the world. A mindset of
innovation, accountability and customer focus inspires us to be the
most efficient, safe and reliable choice for our customers and the
patients they serve. In return, we offer challenging careers,
accelerated professional growth and the opportunity to be part of
The Project Manager is an essential partner with the Operations and
the site leadership team and is accountable for driving results in
a dynamic environment by driving projects to completion. The
Project Manager has a strong scientific and technical understanding
of Alcami services with the ability to effectively interact and
communicate directly with highly educated, innovative industry
thought leaders. The Project Manager leads cross-functional project
teams to deliver against contracted commitments and timelines. The
Project Manager must have in depth knowledge of a product lifecycle
through the regulatory phases from pre-clinical to
commercialization to identify and propose the necessary activities
to achieve successful regulatory approval. This role includes
assessing the scope of services in the contract and developing
project plans, directing project activities, tracking project
status, and serving as the primary point of contact for all
customer communications. The position requires superior leadership
behaviors of the Alcami core competencies and non-negotiables, as
well as expertise in functional competencies included in this
profile. In addition, this role requires the ability to lead and
influence multi-disciplinary project teams meeting standards in a
GMP environment, and demonstrated skills and abilities in critical
thinking, problem solving, detail and results orientation, managing
multiple and sometimes competing priorities and excellent verbal
and written communication.
* Establishes, leads and manages a project team of technical and
scientific team members to deliver against contracted commitments
and timelines for Alcami services.
* Assesses the scope of services included in the contract and
creates a detailed timeline outlining actions, deliverables and
* Identifies and requests resources, including technical and
scientific resources required to execute the project from
functional areas (i.e. operations, formulation development,
analytical development, quality, engineering, etc.).
* Reviews the contract scope and project schedule with the project
team to identify gaps, risks and additional proposed services that
may be required to successfully execute the project.
* Communicates to the Sales and Business Development Manager any
required items that are out of scope and may require amendment to
* Leads the project kick-off meeting with the customer introducing
the team and presenting the scope, timeline, risks and proposed
* Leads project team activities and actions, monitoring progress
against the established timelines and providing regular updates to
the internal stakeholders and customers. Leverages own technical
and scientific knowledge to recognize and manage activities at risk
to exceed timeframes or scope of the contract.
* Resolves conflict by providing proactive escalation of project or
customer relationship issues to internal stakeholders and provides
a proposed corrective course of action. Manages the response and
action plan with the customer to resolve conflict.
* Maintains accurate timelines using MS Project, open actions using
MS Excel, monitors forecasted revenue using the AX system, and
tracks and manages GMP documentation through Master Control, the
Company s validated electronic document management system. Updates
site files used to calculate and display project metrics such as
Right First Time, On Time Delivery and Schedule Adherence.
* Demonstrates fiscal responsibility to monitor, forecast and
calculate the profitability of the assigned project(s).
* Works closely with the Sales and Business Development Manager to
generate change orders and new proposals for additional work
associated with the project.
* Serves as main point of contact for the customer for all project
related activities and issues, including any questions or disputes
related to invoices.
* Partners with the Director of Project Management to implement
improvements to the Project Management processes and systems.
* Ensures timely completion and compliance with cGMP and all other
relevant company training requirements.
Education and Experience
* Bachelor s degree in a scientific discipline required. Master s
* Pharmaceutical or biotech experience required.
* CMO or CDMO experience preferred.
* Prior experience in a customer-facing role required.
* Formal project management training or certification
* 3 years of related pharmaceutical or biotech experience
* 2 years of experience leading multi-disciplinary project teams in
a service business required.
* 5 years of related pharmaceutical or biotech experience
* 3 years of experience leading multi-disciplinary project teams in
a service business required.
* 8 years of related pharmaceutical or biotech experience
* 5 years of experience leading multi-disciplinary project teams in
a service business required.
* Ability to independently manage projects of any size, scope and
* Ability to coach and provide direction to less experienced
* Consistently demonstrates honesty and integrity through personal
* Follows all safety policies and leads by example a safety first
* Produces high quality work product with a focus on first time
* Complies with the company code of conduct and policies and
Alcami Core Leadership Competencies
* Thinks strategically. Quickly identifies and acts on
opportunities. Considers the downstream impact. Seeks to understand
the why. Focuses on work that matters.
* Develops organization and others. Takes ownership to develop self
and others. Seeks out new opportunities and experiences for
* Acts decisively. Makes and acts on decisions quickly. Makes
decisions with the customer and their patients in mind. Meets
commitments with a sense of urgency. Seeks ways to be more
* Drives performance. Holds self and others accountable. Delivers
results first time right. Never settles for status quo. Willing to
have tough conversations. Asks for feedback and takes action to
* Passion for customers. Listens to understand. Asks the right
questions. Gets to the heart of the matter and uses that insight to
* Works collaboratively. Seeks out the experience of others with
the aim for better results. Open minded regardless where ideas
originate. Flexible and easy to work with.
* Technical and scientific knowledge and understanding of Alcami
services within the customer s project and contract.
* Knowledge of a product life cycle through the regulatory phases
from pre-clinical to commercialization to identify and propose the
necessary activities to achieve successful regulatory approval.
* Technical and scientific aptitude to lead the project team, set
reasonable timelines and milestones.
* Ability to interact and communicate confidently and represent
technical details when speaking with innovative thought leaders and
highly educated individuals (Master s Degree,
Keywords: Alcami Corporation, Wilmington , Project Manager II- Labs, Executive , Wilmington, North Carolina
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