Associate Director/Director of Process Development- Vaccines

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 25, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Associate Director/Director of Process Development- Vaccines Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2021. Associate Director/Director of Process Development- Vaccines Job ID R0023675 Date posted 02.16.2021 Location Cambridge, Massachusetts By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director/Director of Process Development, Vaccines in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As an Associate Director/Director of Process Development in the Vaccines CMC organization, you will be empowered to manage process development and tech-transfer activities for clinical and commercial manufacturing . You will be managing a team at the Cambridge, MA site.: POSITION OBJECTIVES: This position is responsible for design, development, optimization, trouble-shooting, continuous improvement, data trending and monitoring of DS process to support clinical/commercial manufacturing The position will lead the team in terms of strategy, planning and execution project and product deliverables under the responsibility of the Head of Process Development, the POT Lead and the Head of Vaccine Operations CMC. It is an expectation, to both initiate and support operational and strategic initiatives, lead and monitor ongoing internal deliverables, direct special projects, and work effectively in under the "One Team" context with our commercial manufacturing colleagues. POSITION ACCOUNTABILITIES: Leads initiatives by the Cambridge Team for scouting new technologies for product development. Leads and supports the Cambridge process development team in testing the new methods and tools in house at small scale to represent the commercial process. Based on the "One Team' theme provides support for ongoing investigations and initiatives together with our commercial manufacturing colleagues in the External Manufacturing group. To ensure resource utilization in the process development group is well managed. Providing appropriate support, background materials, and drafts of deliverables to Head of Process Development to ensure that key projects are completed in a timely manner with high quality. Effectively fills gaps in information within the organization by working with other senior leaders across the organization. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: A Bachelor's degree with 15+ years of experience or a Ph.D. with 10+ years of experience, in biologics process development and manufacturing. At least 10 years of people management Ability to handle multiple priorities, build strong relationships across all levels and facilitate excellent team leadership skills. Ability to network externally and internally. Strong communication skills with a proven track record of influencing others Must be able to identify problems/ risks/ issues and facilitate issue resolution and risk mitigation during the course of product development. Experience with single-use cell culture and/or purification technologies strongly desired Experience with analytical methods used in support of process development strongly desired Experience with supporting regulatory filings, preferably BLA/MAA is desired Experience in downstream processing utilizing chromatography and ultrafiltration strongly desired Hands-on experience of validation and Biologics cGMPs including ICH guidance documents would be highly advantageous Excellent oral and written communication skills required Well organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility. Good time and project management skills, ability to oversee several projects simultaneously. Comply with Takeda safety practices and standard operating procedures. Exhibit and promote Takeda Core Competencies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Check out where you could be
working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Associate Director/Director of Process Development- Vaccines, Executive , Cambridge, Massachusetts