Beschreibung
Scientist, process scientist, GMP, pharmaceutical products, FDA, EUMDD
PROCESS SCIENTIST
PRINCIPAL RESPONSIBILITIES:
- Support the Technical Owner in technical, quality and compliance risk assessment and development of mitigation strategies
- Collaborates with different functions in product improvement projects
- monitors technical process and product performance
- supports failure investigations (escalation of quality or compliance events)
- executes or follows-up on execution of technical projects
- understands the technical aspect of the life cycle strategy of products
- applies the science based risk approach and regulatory intelligence
- monitors technical process and product performance across internal and external mfg sites
- deploys the platform standardization policy as appropriate
- reviews technical product & process risk profile and criticality analysis
- looks for technical improvement and innovation opportunities
- co-ordinates with mfg sites and process engineering the implementation of new process technologies (where appropriate)
- identifies and resolves issues, anticipating to potential future issues
- perform technical risk assessments
- draft technical documents such as tech transfer plan and reports and bring them to review and approval
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS
FUNCTIONAL KNOWLEDGE/EXPERTISE
Strong expertise with regard to parenteral pharmaceutical products, manufacturing processes & tech transfer of parenteral products
Good knowledge of Q&C/regulatory requirements/GMP/EHS
PERSONAL & INTERPERSONAL SKILLS/LEADERSHIP SKILLS
Ability to support the leader of cross functional/cross-region project team
Ability to manage complexity and change
Ability to interact at different levels of the organization (including Sr. Management) Ability to work under pressure and resolve conflicts
Ability to work independently under general direction, having a good sense of prioritization of assigned tasks and manage time accordingly Ability to create a result oriented project team
PERSONAL ATTITUDE & MINDSET
Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
Understands culture differences
Goal oriented
Communicates, motivates, negotiates and is an assertive person having impact
Shows a high sense of responsibility regarding professional activities
DEGREE:
Minimum requirements: BS/BA with 5-7 years' experience, M.S. with 3-5 years' experience in pharmaceutical development or pharmaceutical manufacturing of parenteral products or related post graduate academic experience/education.
ABOUT SENTINEL:
In a connected world, relationships matter. for over 15 years, our recruiters have been building networks that connect the very best technologists. No is better placed to reach the people who can help you succeed. We can name some of the global top 10 life-science companies as valued clients and what we offer goes beyond the normal scope of the client-agency-candidate relationship. With our head office in the UK and our new Swiss based office, your profile will be treated with due care and attention, and matched to the best possible role. We can offer advice on CV structuring, interview technique and a concierge service when finalising your contract or permanent offer with assistance in regards to booking flights/hotels, salary simulations, advice on local culture/living expenses and information on your new employer.
We have placed quality engineer's, CAPA consultants, Product development engineers, Auditors and process scientists across Europe and have a strong understanding of the requirements of our clients highly FDA/EUMDD/PAL regulated consultants.
Scientist, process scientist, GMP, pharmaceutical products, FDA, EUMDD