CMC Regulatory Affairs manager
CMC Regulatory Affairs manager
Posted on :
10-02-2025
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1 Vacancy
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Job Description
Job Title: CMC Regulatory Affairs manager
Job Location: India
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
Work Schedule
Standard (MonFri)
Environmental Conditions
Office
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 lifechanging 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:
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 awardwinning 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 wellbeing of our employees. We have a flexible working culture where PPD Clinical Research Services truly value a worklife 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 100000 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!
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.
Standard (MonFri)
Environmental Conditions
Office
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 lifechanging 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 crossfunctional 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 crossfunctional problemsolving to enable a highperforming team.
- Master degree in lifesciences;
- At minimum 5 years CMC project experience;
- Experience in working with biologics is a plus;
- Excellent planning and organizational skills able to multitask in a multicultural environment and prioritize
- Strong analytical problem solving and critical thinking skills with actionoriented 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 selfstarter with the ability to work in a fastpaced environment and adapt quickly to changing needs and priorities;
- Fluent in English – our working language;
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 awardwinning 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 wellbeing of our employees. We have a flexible working culture where PPD Clinical Research Services truly value a worklife 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 100000 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!
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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Employment Type
Full Time
Key Skills
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