(S)VP Manufacturing - Biopharmaceuticals - MA

Waltham Permanent USD350,000 - USD450,000
  • Build high performing team across Analytical Dev and Manufacturing
  • Join a fast paced, growing Clinical Biopharmaceutical Company

About Our Client

Our client is a clinical-stage biopharmaceutical company focusing on neuromuscular diseases. Their mission is to discover and develop these differentiated therapeutics which treat patients that do not have a current alternative. This publicly traded company was founded in the past decade and has massive growth potential.

Job Description

  • Build a high performing team by recruiting and developing talent across process and analytical development and manufacturing.
  • Lead and develop a strong team-based culture, fostering commitment to scientific and operational excellence while driving successful execution for the portfolio
  • Develop and implement Manufacturing Science and Engineering Technical strategies for clinical and commercial manufacturing of biologics
  • Ensure success of all clinical and commercial production activities including tech transfer to contract manufacturing organizations.
  • Provide a global effective strategy to optimize manufacturing sites and CMOs throughput, efficiencies, and improved batch success rates, supporting expansion and growth of future commercial campaigns
  • Responsible for long-range strategic planning and implementation for clinical and commercial manufacturing for the portfolio, development, and management of manufacturing, technical and engineering teams to drive the product-specific technology strategy, from development of clinical through commercial manufacturing.
  • Develop the supply strategy for the company's programs to meet the first 3 years of demand in collaboration with the commercial team
  • Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations
  • Lead the manufacturing team in operations, regulatory preparedness planning and client and regulatory agency visits and inspections.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Advanced degree in biological or engineering disciplines with minimally 15 years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing and process development technical leadership role within the gene therapy industry
  • MS/MA/PhD degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline and at least 15 years of related experience; or
  • Experience with Biological products and gene therapy technologies is critical
  • 15+ years progressive experience in a key leadership/management role in pharmaceutical development especially for late stage and commercial manufacturing
  • Deep understanding of the science and technology underlying biological manufacturing as well as analytical techniques that support clinical and commercial manufacturing activities
  • Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, process control strategy, process robustness, and process engineering for biologic products
  • Demonstrated track record of success in clinical and commercial production and preparing and defending CMC submissions for FDA and foreign regulatory inspections and approval
  • A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
  • Strong understanding of the technical aspects of manufacturing, testing, and controls as well as financial systems and controls
  • Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution
  • Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues to the development and executive teams
  • Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them

What's on Offer

  • Key Member of Senior Leadership Team
  • Amazing Stock options
  • Annual bonus
  • Excellent benefits package
  • Novel drug portfolio with strong pipeline
  • Start up culture
  • Contribute to development of cutting edge treatments for rare diseases
Faith Emery
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Faith Emery
Job Reference