About the Job:

We seek a highly motivated Sr. Project Manager to join a rapidly growing team. The Sr. Project Manager will be a strategic partner and hands-on with a passion for driving results in a customer- and technical-centric environment to advance the commercialization of lipid-based formulation technologies in dietary supplements, foods, and beverages. The successful candidate will strengthen the Project Management operations and ensure that the company provides superior internal and external customer service levels. The Sr. Project Manager will give coordinated cross-functional project plans for internal and external product development programs by the program strategy. The Sr. Project Manager will also provide project leadership on internal strategic initiatives, span across functional areas, provide practical and effective solutions for the business, and will also coordinate activities related to formulation development, product development, cGMP manufacturing, and stability programs for successful discovery, pre-formulation, formulation development, analytical development, cGMP manufacturing and stability studies for drug product development from clinical to commercial manufacturing. The Sr. Project Manager will receive cross-functional assistance from each department, including a Business Projects Manager, to absorb and understand project variables within each business segment. The Sr. Project Manager reports to the Chief Executive Officer.

• This position requires a scientific background with global experience in process improvement, current Good Manufacturing Processes (cGMP) for dietary supplements, foods, and pharmaceuticals, and manufacturing in a regulated environment. The CMO/CDMO/CRO environment is fast-paced and requires an elevated level of multi-tasking skills that are essential to the success of this position. Internal partnerships are also a must, as Sr. Project Manager will be required to learn and understand the capabilities of each business segment in collaboration with the rest of the organization to drive project completion successfully.
• Job Description:
• Work closely and communicate effectively with cross-functional teams and leaders from R&D, Manufacturing, MSAT, Quality Assurance, and Analytical Development to ensure the team is set up to deliver on all project management requirements for successful product development and commercialization.
• Lead project management activities to determine and maintain project timelines, create/send reports, vendor relations, estimated effort level, resource/budget requirements, etc.
• Collaborate with technical, finance, and business development leadership to oversee the authoring of research plans and stability programs and oversee the scope of work change orders
• Assist in the creation of product development plans from a project management standpoint with a focus on bringing new products into the market on budget and on-time
• Establish operational work plans with CMO/CRO/CDMO providing project management leadership and oversight of all stages of product development and manufacturing
• Actively provide informed perspective to senior leadership on all project-related tasks and milestones, including developing risk management and scenario planning to drive effective decision-making.
• Lead a team of business project managers to drive development and timely completion by ensuring cross-functional alignment and accountability
• Prepare and distribute meeting agendas, summaries, status reports, memos, meeting minutes, and coordinate team activities as needed.
• Develops a communication plan that will ensure seamless communication with the internal and external project team and customers
• Partners with business development leadership to support new business development opportunities as needed
• Build effective relationships throughout the organization and remove obstacles to success
• Other project management duties as assigned

Requirements:

A Bachelor's Degree in a scientific or engineering discipline

• Experience (5+ years) in dietary supplement and pharmaceutical development with prior experience in project management and strategic planning within CMC and commercialization
• Experience in process, formulation development, and technology transfer with a clear demonstration of knowledge in product development, CMC, and manufacturing is required
• Previous experience managing relationships (external manufacturing) with CMO/CRO/CDMOs and customers
• Experience using project management tools and practices
• Comfortable working in a fast-paced and deadline-driven environment
• Must be able to work independently and manage multiple projects
• Ability to understand complex business processes and adapt solutions to meet the needs of a scale-up business that is quickly maturing into a /mid-size company
• Proven analytical skills, with the ability to approach problems logically and systematically
• Excellent leadership, written and verbal communication skills, and ability to influence others without direct authority and to navigate in a matrix environment
• Excellent negotiation and facilitation skills, with a strong customer-service focus.
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment.
• Must be able to think critically and strategically
• Understanding of pharmaceutical product development and manufacturing.
• Proficiency in Microsoft Office programs, including Office 365 (Word, Excel, Teams, PowerPoint, OneNote)
• Occasional evening and weekend work may be required.

Preferred Skills:

• 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 the status quo.
• Prioritizes tasks according to business objectives and can pursue several goals simultaneously, with great 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.

About the company:

With six patent families and 28 granted and pending patent applications, our client's technologies are a unique, scalable solution to solubility and stability. We've identified specific ratios of excipients to render nutraceutical and pharmaceutical active ingredients at room temperature stable within lipid nanoparticle structures in an aqueous environment. We've also created the processing conditions to scale it successfully to fit players with the omnichannel distribution.

We work with large ingredient suppliers and multinational brands to fortify finished products with essential vitamins and functional ingredients capable of transparent labels and accurate claims. Our client's technology is leveraged in end-use applications today's consumers demand like beverages, snacks, on-the-go solutions, and more to capture new market share, innovate product verticals, solubilize unmanageable doses, power underutilized ingredients, and feature ingredients that historically weren't an option.

Far superior to the one-size-fits-all technologies currently available in the market that can't be scaled for mass distribution, our client has taken the traditional Pharma Model as a CDMO. As a strategic partner with diverse capabilities, clients engage our partner for R&D formulation development, supported by their in-house internationally accredited analytical lab for speed to market, and manufacture bulk liquid that can be used as an ingredient in finished products as a ready-to-use good or dehydrated into a powder.

Clients are using our partner's technologies as an end-to-end solution provider for reasons including but not limited to: tunability of particle size and type fit to active ingredients and the end use of the application, clean labels without the use of surfactants, solubility both in finished goods but also within the body, batch-to-batch consistency, a water-based dead formula that does not change the characteristics including taste and texture of the finished good it will be used in.

At our client's facility in Austin, Texas, clients engage us for R&D to formulate according to target product profiles outlining physical and chemical characteristics. Complete with an internationally accredited ISO analytical in-house laboratory, we tech transfer from benchtop to commercial scale manufacturing. We then manufacture their formulation as a bulk liquid used as an ingredient in finished products or as a ready-to-use good. The bulk liquid can also be spray dried or lyophilized into a powder that, when hydrated in various liquids, like gastrointestinal fluids or aqueous beverages, rapidly reconstitutes back into stable, encapsulated lipid particles.