Drug Product Program Manager

By | April 25, 2021

Description

Job Description:* 6-month contract position with potential to become permanent * Fully remote position (work from anywhere in Canada) * Excellent opportunity for a skilled project manager with aseptic manufacturing experience* Competitive target salary commensurate with experience Who are you? You’re an experienced project or program manager, with experience in the pharmaceutical aseptic manufacturing industry, and a desire to work with clients and organizations making an impact on global health in the fight against COVID-19. You’re interested in working with a diverse, progressive, and close-knit team, in a company that values coaching and mentorship for staff at all levels. If you are resourceful, organized, have great communication and project management skills, and are excited by the opportunity to make a meaningful contribution to an exciting project, this could be your next role. Who is the employer? Our client is a Canadian engineering and compliance firm, specializing in equipment engineering, project management, and compliance and validation. Established over 20 years ago, they serve medium to large clients in regulated industries (pharmaceutical, medical device, nutraceutical, cosmetics, and more). They offer a close-knit, flexible company culture and small team environment, with a management team that prioritizes mentorship, learning, and professional development. They are currently working with a pharmaceutical manufacturer who are looking to expand their drug product to more global markets (China and the UK). They have an immediate need for a Drug Product Program Manager to help them manage the contract manufacturing organizations (CMOs) in those regions. Could that be you? What you’ll be doing As the new Drug Product Program Manager, you will act as the key Contract Manufacturing Organization (CMO) contact, and will lead, track, follow up and monitor project timelines, scope, and budget, and ensure alignment with project deliverables. Your responsibilities will include: * Working with the CMO to generate, review and approve the necessary business agreements* Ensuring CMO work proposals (e.g., Statements of Work, Master Services Agreement) accurately reflect the requested activities* Applying basic financial modelling to CMO cost proposals for comparison to other CMOs and integration into total supply chain cost analysis* Leading and managing the technology transfer process with the CMO* Ensuring that the most current approved product information is provided to the CMO and performing a gap analysis of outstanding items* Assisting CMO with any equipment changeover requirements for the new process* Reviewing processing instructions, prepared by the CMO, with technical and quality representatives* Preparing technical reports for engineering runs/comparability batches if not prepared by the CMO* Coordinating and ensuring the timely review of CMO documents within the project team* Tracking material availability for forecasted component requirements* Reviewing CMO invoices for accuracy with completed work* Providing updates to Senior Management, as well as escalates issues impacting timelines and/or deliverables Your success will rely on your ability to manage contract manufacturing organizations, while representing the customer effectively and making sure their expectations are met. Strong communication skills will also be essential to success – your ability to communicate ideas effectively and solicit feedback from various stakeholders will be critical to building coalition around the program. This is an incredible opportunity for an experienced project manager looking to make an immediate impact. If you are diligent, goal-oriented, and forward-thinking, you will thrive in this role. This is a 100% remote-based position working full-time (40 hours/week, with potential for some occasional overtime). As you’ll be dealing with global CMO contacts and other stakeholders, flexibility will be required in your schedule to accommodate communication in various time zones as needed. Qualifications * Ideally, 10+ years of relevant industry experience (but open to experienced candidates at various levels of seniority) * Experience in and knowledge of the aseptic pharmaceutical manufacturing industry is essential * Project and/or program management experience is essential * Experience using project management tools such as MS Project and Excel * Post-secondary degree in science or engineering is preferred * Experience with or exposure to Contract Manufacturing Organizations would be a bonus Your Application We value diversity and inclusion and encourage all qualified people to apply. We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted. At Ian Martin, we connect people with meaningful work. We work with people like you for similar technical roles. If you apply, be sure to create a profile with us. That way, great technical jobs will come to you before they even get to the job boards Job ID: 18544561
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