Shire CMC Program Manager (m/f) - experienced Project Manager for the pharma industry in Strasse (Baxalta), United States

Shire’s R&D pipeline is with 30+ programs one of the most promising and complex pipelines in the entire biopharmaceutical industry. Research and Development programs in 6 therapy areas encompass pharmaceutical and biopharmaceutical substances with highly diverse forms of administration. PDTS (Process Development and Technical Services) in Austria operates in a global environment collaborating with over 30 locations worldwide to develop processes and analytical methods for new substances as well as to support large-scale production for approved medication. PDTS strives to find innovative ways of successfully implementing product-related ideas for the benefit of our patients.

About the position:

The Product Life Cycle Management (PLCM) Program Manager is experienced in the use of project management tools and principles and manages activities of two or more product teams and relevant sub-teams. The PLCM program manager will ensure the programs stay on track and are within the expected budget and timelines. The PLCM program manager needs to be a great communicator and problem solver with a proven ability to identify risks and escalate issues when required.

Roles and responsibilities in detail:

  • Leads the product teams & sub-teams together with the CMC lead (the technical/CMC expert for the product in question)

  • Drives execution of programs by translation of product strategy into team goals and milestones in alignment with stage gate process

  • Facilitates the use of project management tools to achieve a balanced, data driven and risk-based decision making process

  • Definition of mitigation and/or contingency plans​

  • Executes scenario planning and risk assessments

  • Owns program documentation including: agenda, minutes, action items, dashboards, goals and milestones, risk register, mitigation plan, decision log, FTE tracker, timeline, etc.

  • Resolves project constraints and prioritizes tasks together with CMC lead

  • Ensures project progress and upcoming deliverables are understood by the team by using PM tools.

  • Holds team members accountable for on-time completion of tasks or milestones assigned to support program plan

  • Reports program status into governance meeting with CMC lead, as appropriate

  • Responsible for the program budget, PDTS resource allocation/tracking and overseeing capital expenditure, as appropriate

  • Coordinates and schedules lessons-learned sessions and team meetings

  • Actively models behavior to support the development and maintenance of a high-performance team via effective meeting management, business communication, and timely follow-up and escalation as appropriate

  • The person will be located in Vienna

Skills you need:

  • Minimum 5 years of project management experience in the Chemistry, Manufacturing & Controls (CMC) environment, ideally with 5-8 years in the biotechnology/pharmaceutical industry.

  • Bachelor’s degree in the life sciences, business, chemical or industrial engineering or equivalent required; a Master's degree in a relevant area and/or PMP certification desirable.

  • Proficiency in prioritizing and driving complex programs to milestone completion

  • Ability to facilitate global cross-functional teams in a matrix environment

  • Knowledge of biotechnology/pharmaceutical product development process including manufacturing process, comparability/feasibility studies, stability studies, analytical development and clinical/commercial operations

  • Demonstrated competency and hands-on experience of typical CMC activities

  • Strong communication skills to effectively inform stakeholders across all levels of the organization

  • Strong written and oral presentation skills.

  • Experience at working both independently and in a team-oriented, collaborative high pressure environment is essential

  • Strong leadership skills (persuasive, encouraging and motivating)

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria. at

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary for this position is € 4.094,41 gross per month (full-time); increased payment is possible. We are looking forward to your application.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.