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CMC Regulatory Affairs manager

Job Id R-01303000 Job Type フルタイム Category 品質・薬事 Remote ハイブリッド
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
This a client dedicated role; To further strengthen our Project Management team, we are looking for a talented CMC Project Manager. This position will occupy a key role supporting Chemistry, Manufacturing and Controls (CMC) development for our therapeutic antibodies, ensuring that projects successfully move forward within and across functions. You will perform planning, controlling, monitoring and reporting for assigned project in collaboration with the CMC Leads and the project teams. This includes CMC activities like process development, analytical development, product development, technical transfer, dossier development, clinical manufacturing and project strategy. The ideal candidate will be detail driven and have a proven track record driving project success within CMC in the pharma/biotech industry.


Report to:

CMC project management Leader

Key Accountabilities and Responsibilities:

· Responsible for achieving project goals, including timelines, budget, and scope.

· Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs

· Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk;

· Build strong working relationships with internal and external key stakeholders to ensure timely completion of CMC activities by continuously monitoring progress;

· Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan;

· Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team;

· Perform scenario simulations and advise on optimum development planning, as needed;

· Prepares and leads project team meetings including issuance of agenda, actions and meeting minutes to be documented, communicated and committed.

· Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.


Qualifications:

· Master degree in life-sciences;

· At minimum 5 years CMC project experience;

· Experience in working with biologics is a plus;

· Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize,

· Strong analytical, problem solving and critical thinking skills with action-oriented follow through

· Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships

· Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;

· Quality conscious attitude;

· Demonstrated project management skills, responsiveness to issues, and passion for contributing to the development of new medicines

· Excellent communication skills

· A self-starter with the ability to work in a fast-paced environment and adapt quickly to changing needs and priorities;

· Fluent in English – our working language;

What we offer:

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.  

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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