Outsourcing Coordinator
Il y a 5 mois
Location:
**MECHELEN**
**#22103**
Will you be our new ambassador?
**Jefferson Wells Life Sciences** specializes in supporting **pharma & biotech companies** in their daily challenges. Hence our interest in **experts** like you to join our team.
Let's look together at your first challenge with us
**Outsourcing Coordinator - Analytical Development**
**Scope of work**:
- Act as a Single Point of Contact (SPOC) for our external contract labs along with External
Alliance Manager SPOC.
- Ensure GMP compliance with regulatory requirements.
- Support Analytical Development (AD) departments with their relationship and communication with external laboratories (ECLs) and Contract Development Manufacturing Organizations (CDMOs)
- Support clinical release and stability (CRS) with capacity planning at preferred external
contract labs.
- Assist with the initiation of Work Orders (WO’s)/Purchase Orders (PO’s) at external contract labs and CDMOs (through the close collaboration with External Alliance Manager, AD project managers, and Contract Management teams.
- Assist with the scheduling of weekly/monthly analytical meetings with CDMOs and ECLs to support AD project timelines.
- Support the Stability Project Owners, release planners and AD project managers with
project timelines and due date tracking of analytical activities at CDMOs and ECLs Connection with other ECL SPOC colleague and External Alliance manager to ensure adequate capacity planning at external ECL sites for AD activities.
**Profile**:
- Experience with pharmaceutical analytical testing
- Experience in small molecule/synthetic chemistry, analytics, and stability.
- Proven ability to build and maintain customer relationships, shows strong communication skills, internally and externally.
- Ability to foster team productivity and cohesiveness, and to work collaboratively,
internally and externally
- Experience with GMP guidelines, policies, pharmaceutical legislation and industry practices concerning analytical development in clinical development.
- Knowledge of clinical development processes and phases of development within the
pharmaceutical industry.
- Project management and problem solving skills
- Background in pharmaceutical QA processes and procedures (i.e. deviation, CAPA, Change Control, Quality Agreements, audits)
- Bachelor’s degree in chemistry, Pharmaceutical Sciences, Bio-engineering or
equivalent.
- 5 years’ experience in the biopharmaceutical or pharmaceutical industry.
- Fluency in English
- Dutch is a plus but not required
**What can Jefferson Wells do for you?**
As an ambassador you have the opportunity to grow within international companies where you can build a **strong network**. Through a personal **follow-up**, you receive **quality support** in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal **training** and **education**.