SENIOR PRODUCT TRANSFER MANAGER - Indiana Pennsylvania

Company: Advanz Pharma Corp
Location: Indiana, Pennsylvania
Posted On: 11/21/2024

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.About the RoleAs ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Senior Product Transfer Manager.What You'll Do:

• Project Management of and participation in technical transfer activities with associated document authoring and review, including Project budget planning and control.
• Provision of technical support and expertise to all relevant activities within the business unit.
• Project management of assigned projects including to monitor execution of product supply integration plan from Global Operation perspective; highlight risk and issues (with proposed mitigation plan) to line manager that could impact on continuity of product supply during transition period from seller.
• Authoring, review and approval of technical documentation (BMRs, technical reports and summaries, etc) to support manufacturing & regulatory activities.
• Review and approval of sections of Regulatory Dossiers (Module 2 and Module 3) in CTD format for use in all submission related activities.
• CMO site attendance as required to resolve manufacturing/technical issues affecting continuity of supply of products.
• CMO site attendance to support key strategic initiatives such as Technical Transfer of Products and Processes, introduction of new APIs or any other projects requiring Technical Support or Project Management.
• Other tasks as delegated by Line Manager which contribute to overall running of the business unit.About YouWe are looking for highly motivated individuals who are passionate about making a meaningful difference to patients' lives.For this role, you will also have the following:Qualifications:
  • Graduate with Chemistry, Pharmacy; or other technically relevant graduate level qualification.
  • A post graduate Degree/doctorate is desired in similar fields.Knowledge, Skills & Experience:
    • Must have significant experience in a technical role (Production/QA/Formulation development, regulatory CMC) within the pharmaceutical industry in regulated markets.
    • Excellent technical knowledge of all solid, semi-solid & liquid pharmaceutical dosage forms including sterile products.
    • Managed several technical and/or scientific projects of varying complexity.
    • In depth working knowledge of project management methodology (e.g. Prince 2) and practical experience with project management tools e.g. MS Project).
    • Ability to work under pressure and to tight time deadlines.
    • Good Presentation, Analytical (data rational) and Planning skills.
    • Strong attention to detail and proactive approach.
    • Proactive nature with focus on proactive prevention of possible issues.
    • Excellent interpersonal, communication and organizational skills, Influencing / Assertiveness.
    • Persists with challenging situations - does not give up in spite of barriers and obstacles.
    • Ability to demonstrate strong Project Management skills - on time delivery of actions from cross functional teams, timely resolution of issues and excellent budgetary control.
    • A positive and 'can-do' approach, biased towards finding solutions and embracing change.
    • Inspired by our values of entrepreneurship, speed and integrity.
    • Learning agility and 'scalability', with a desire to continuously improve and develop as ADVANZ grows.
    • Work collaboratively across all business functions with an open, honest, and respectful cooperation.
    • Ability to have fun and thrive in a growing, unique, and inclusive work environment.Why ADVANZ PHARMA?The success of any company is driven by its people, and we are no different.At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you'll be empowered to own your work, explore new possibilities, and make things happen.But there's more to you - and us - than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles - we have an active ADVANZ PHARMA Women's Network; almost 40% of our managers are women.We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.To join us on our exciting journey, Apply now!
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