Project Manager

August is seeking a Project Manager - Operations to join our growing Project Management Organization! The Project Manager is a technically knowledgeable team member with proven abilities to support operations and customer project activities.

The Project Manager will be a hands-on with a passion for driving results in a customer centric environment. The successful candidate will strengthen August Bioservices Project Management operations and ensure that the company is providing superior levels of internal and external customer service. The Operations Project Manager will provide project leadership on internal initiatives that are strategic in nature, span across functional areas, provide practical and effective solutions for the business and will also coordinate activities related to drug discovery, pre-formulation, formulation development, analytical development, cGMP manufacturing and stability studies for drug product development from clinical to commercial manufacturing. The Project Manager will receive cross-functional assistance from each department to absorb and understand project variables within each business segment. The Operations Project Manager reports to the Director of Project Management who is responsible for providing operational leadership for operations and customer projects in drug discovery, drug development and manufacturing.

For this position, a scientific background with global experience in process improvement, current Good Manufacturing Processes (cGMP) and pharmaceutical manufacturing in a regulated environment is highly desired. The CDMO and CRO environment is fast-paced and requires an elevated level of multi-tasking skills that is essential to the success of this position. Internal partnerships are also a must as project managers will be required to learn and understand the capabilities of each business segment in collaboration with the rest of the organization to successfully drive project completion.

Responsibilities

• Determine and maintain project timelines, estimated level of effort, and resource/budget requirements
• Prioritize project activities , ensuring deadlines are achieved and the project team effectively communicates about progress and obstacles , both within the project team and to stakeholders
• Manage and track all project related activities to ensure successful completion of objectives
• Ensure that process improvements are both effective and durable by assisting process owners with training, documentation , and establishing process controls
• Recognize and encourage behaviors that contribute to teamwork and improve outcomes , leveraging the unique talents of each project team
• Prepares meeting agendas, manages and leads video/teleconferences, tracks action items via meeting minutes, and coordinates team activities as assigned.
• Develops a communication plan that will ensure seamless communication with the project team, customer, project steering committee, and all stakeholders.
• Actively engages in and supports new business development opportunities.
• Manages changes in scope of projects by requests of change orders via Requests For Proposals.
• Manages client relationships ensuring on-time project execution and within-budget delivery.
• Accountable for hosting client visits to site. Ensures that all personnel involved with these activities on site are fully briefed regarding the nature of the business enquiry, the customer and their business interests.
• Build effective relationships throughout the organization and remove obstacles to success

Requirements

• A Bachelor’s Degree in scientific or engineering discipline required
• Experience (5+ years) managing cross-functional teams or projects in a CDMO, pharmaceutical development, or GLP/GMP manufacturing setting, or analogous technical industry. 7-12 years preferred
• Demonstrated experience in the use of process improvement methodologies, such as Lean or Six Sigma, or related practical approaches ( 5 Whys, 6 Ms , 7 Wastes, brainstorming, 2x2 prioritization matrix, Exploratory Data Analysis, etc. )
• Ability to understand complex business processes and adapt solutions to meet the needs of the business
• Proven analytical skills , with the ability to approach problem s logically and systematically
• Knowledge and experience in the application of project management techniques and tools.
• Excellent leadership, written and verbal communication skills and ability to influence others.
• Excellent negotiation and facilitation skills, with strong customer-service focus.
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment.
• Ability to lead multi-disciplinary project teams.
• Understanding of pharmaceutical product development and manufacturing.
• Knowledge of FDA regulation/ICH guidelines, U.S. drug development process and project management practices preferred.
• Proficiency in Microsoft Office programs including Word, Excel and MS Project.
• Proficiency with Smartsheet, ERP, CRM, and Documentation Systems.

Success Factors

• Must have exemplary interpersonal skills; should be an effective team leader who can manage and lead in a matrix environment.
• Able to professionally handle multiple and sometimes competing priorities.
• Thinks strategically. Quickly identifies and acts on opportunities.
• Passion for customers. Listens to understand. Asks the right questions.
• Communicates clearly to both internal and external customers in written and oral form.
• Listens and responds positively to external customers, partners and colleagues at all levels.
• Drives performance. Holds self and others accountable. Does not settle for status quo.
• Prioritizes tasks according to business objectives and can pursue several objectives simultaneously, with a high attention to detail.
• Proactively works with stakeholders to mitigate risks and overcome obstacles.
• Makes and acts on decisions quickly. Makes decisions with the customer and patients in mind.
• Meets commitments and timelines with a sense of urgency. Seeks ways to be more efficient.
• Ability to adapt to a fast-paced environment.
• Able to professionally handle multiple and sometimes competing priorities.
• Excellent critical thinking and problem-solving skills.
• Detailed and results orientated.