Specialist Monography and Projects
Il y a 3 mois
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.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
The Specialist Monography and Projects is an individual expert contributor capable of independently lead writing assignments involving a thorough understanding of analytical R&D processes and procedures. You would be leading the stability process and related documents in collaboration with Analytical Product Leaders, ARD and TRD technical experts commercial QC, QA and Regulatory Affairs.
**Your responsibilities**:
- Supporting the Stability process using a QbD approach, for clinical material at all production steps in collaboration with IT Product Analytic Senior Managers.
- Leading the stability intermediate or final report, trending analysis, consistency table, stability plan modification, external and internal COA and stability usage decision in SAP with Analytical Product Leaders, ARD experts, External Third Parties;
- You can support the definition of the control strategy for all Ph1 to Ph3 projects for GMP, Toxicological, biologicals standard, Reproducibility, Engineering, and in-process batches and in agreement with appropriate analytical project leader (APL) and key partners (RA/QA/producer)
- You ensure the consistency of stability documentation that is issued requiring quality check (QC).
- You support Analytical Product Leaders and ensures quality assurance for specific documentation for Stability reports.
- You ensure the consistency and quality level of all documents that are issued requiring mínimal quality check and rework. Ensures quality assurance for all written materials within scope and in line with internal or external procedures.
- You demonstrate skills in effectively handling assignments (including multiple priorities and responsibilities) and assures assigned achievements are achieved within the established time frames.
- You have the ability to work within a complex matrix structure (with Analytical Product Leader, Technical Development Leader, Platform heads and drive the process. Establishes network of communication and continuously facilitating smooth partnerships and interfaces between all groups involved in project delivery.
**Qualifications**:
- MS with 3 years of experience OR BS with 6+ years of experience.
- Degree in Chemistry/Biochemistry/Biology or Administrative field
- Possesses knowledge of internal processes/procedures.
- Good computer literacy
- Possess excellent command over English language (verbal and written).
**Preferred qualifications**:
- Written and spoken local language.
- Sound scientific methodology, critical thinking and problem-solving skills.
- Ability to integrate and work in a team.
- Proactive and taking initiative
- Flexible, and easily adapt to new/unexpected situations.
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.
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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