Career | Project Manager / Senior Project Manager - CMC Operations | Empirico

Project Manager / Senior Project Manager - CMC Operations

Empirico

Madison, WI, US

  • Job Type: Full-Time
  • Function: Product Mangement
  • Industry: Therapeutics
  • Post Date: 07/09/2024
  • Website: www.empiri.co
  • Company Address: , San Diego, CA, 92122, US

About Empirico

Empirico is a biotechnology company focused on the discovery and development of novel medicines which are designed to mimic naturally-occurring genetic variants that confer beneficial effects on health and disease.

Job Description

Empirico, a biotechnology company that combines unmatched expertise in human genetics-driven target discovery with world-class capabilities in siRNA drug discovery, is looking for a talented project manager with experience overseeing external CMC activities. This is an excellent opportunity for an organized and highly-motivated individual to play a pivotal role in overseeing vendors and identifying project risks and challenges, to ensure that timelines and deliverables are met. This non-laboratory role involves close cross-functional collaboration with internal teams, including chemistry, biology, clinical, quality, legal, finance, and regulatory.

Responsibilities

    • Your day-to-day responsibilities will include acting as the primary point of contact for projects, facilitating communication and collaboration between internal teams and external CDMOs and CROs, for CMC development, analytical, manufacturing, packaging, and labeling activities. You will be expected to:
    • Manage  and track timelines, quality, and deliverables for each project and vendor using Excel,  SharePoint, Smartsheet, and other project management tools
    • Collaborate with the cross-functional internal team to deliver quality products on time
    • Proactively identify project risks and work with the relevant internal and external teams towards resolution
    • Provide project updates, including issues, risks and potential solutions to senior leadership
    • Participate in drafting RFPs, partner evaluation and selection, and in tracking, managing, and negotiating new contracts, supply agreements, confidentiality agreements and purchase orders for new and existing vendors
    • Track and review vendor invoices and work with the finance team to process payments
    • Lead project meetings and take part in vendor visits and conference calls
    • Oversee shipments and storage of GLP, GMP, and clinical materials following Empirico SOPs
    • Manage internal and external inventory of intermediates, API, investigational products, retain, samples, and clinical supplies

Requirements

    • Bachelor’s degree in a scientific field such as Chemistry or Chemical Engineering; Project Management Certification is preferred
    • 2-8 years of experience in a pharmaceutical company, CDMO or CRO; previous experience in pharmaceutical manufacturing project management role is preferred
    • Knowledge of applicable GLP, GMP, ICH, FDA, EMA, and MHRA guidance for pharmaceutical manufacturing and testing of oligonucleotides
    • Previous experience in manufacturing of ASO, siRNA, or peptides is preferred
    • Experience managing vendor and partner relationships
    • Proficiency with Word, PowerPoint, Excel,  SharePoint, Smartsheet, and other project management tools
    • Exceptional organizational and time management skills and the ability to multi-task
    • Excellent written, verbal and interpersonal communication skills, with the ability to effectively interact with diverse teams, both within and outside the company
    • Highly motivated team player with a desire to work in a fast-paced and dynamic environment and contribute to a growing biotech organization
    • Ability to travel on a limited basis (<15% of the time) domestically and internationally to partner locations.
    • Applicants must have authorization to work in the U.S.
About Empirico: Empirico is a biotechnology company that discovers and develops novel medicines designed to mimic naturally occurring genetic variants that confer beneficial effects on health and disease. Empirico’s two foundational technology platforms – the Precision Insights Platform™ for genetically-validated target discovery, and the siRCH™ platform for the discovery and development of siRNA medicines – are used separately and in tandem to enable Empirico and our collaborators from the discovery and validation of novel targets to clinically-viable therapeutics. Empirico’s exceptional internal capabilities, augmented by those of its partners, are driving the advancement of a growing and differentiated pipeline of wholly owned and partnered programs. Empirico is headquartered in San Diego, CA with a major second site in Madison, WI.
 
We’re striving to build a strong culture of inclusivity, transparency and collaboration at Empirico, where our diverse and equitable workforce is empowered to contribute to our mission. We always seek the best candidate for the position and encourage you to apply even if your experience or qualifications don’t match up exactly with the job description. Empirico is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
 
To All Agencies: Please do not contact any employee of Empirico about this position. All resumes submitted by agencies to any employee of Empirico via-email or in any form and by any method will be deemed the sole property of Empirico, unless such agencies were engaged by Empirico for this position and a valid agreement is in place.

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