Project Manager: CMO's

21-9-2018 puurs
company profile

Our team provides advanced technical troubleshooting to manufacturing sites all over the world.
In scope is full product lifecycle support, to include co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements during commercial manufacturing. Complex technologies and processes are our area of expertise. We are the ambassadors of technology standardization and Next Gen technology. Globally located, connecting and facilitating connections inside and outside the company is a second nature.
The main focus of this position of Manager MSAT Process Development is to provide technical support for manufacturing done for the company by Contract Manufacturing Organizations (CMO’s) in Europe. Sterile injectable drug product manufacturing (“fill-finish”) includes products in vials, ampules, syringes, or cartridges. Operations include dispensing of ingredients, compounding/formulation, filling, visual inspection. In some cases the products are lyophilized or terminally sterilized. Products includes vaccines, MAbs, complex molecules, peptides, small molecules and diluents.
We believe in team work. The description below is indicative, but the results of the team are the main priority.

job description

Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you'll feel comfortable in this company, who's one of the biggest pharmaceutical companies in the world.

Role Summary:

- Responsible for the technical evaluation of External site change controls and leads complex investigation at those sites.
- Perform technical Due Diligence assessments for new potential manufacturing sites and/or new business opportunities.
- Participate in cross functional teams to identify, evaluate and develop innovative solutions to manufacturing processes and drug product presentations.
- Ability to work independently while managing teams effectively through informal influence
- Utilization of verbal and written communication skills to effectively communicate complex ideas and solutions across multiple levels of the organization.

Role responsibilities:

- Provide technical support to multiple sterile injectable drug products manufactured at internal and external sites.
- Review and provide guidance to manufacturing processes under development by the PEH and PIH development teams.
- Design and oversight execution of Validation batches for all sterile injectable drug products.
- Provide technical support for complex drug product transfer and design and execute registration/validation batches.
- Assess opportunities for innovation in the sterile injectable manufacturing space.

your contribution

Qualifications

- B.S. in relevant science or engineering field.
- 8+ years of pharmaceutical manufacturing and project management experience, MS with 5+ years of equivalent experience or PhD with 2+ years equivalent experience.
- Project management skills to include experience of successful delivery of projects on schedule and to budget.
- Broad knowledge of sterile drug product manufacturing processes is essential. Knowledge should encompass aseptic formulation, filling, and inspection. Freeze drying experience is a plus
- Ability to manage multiple projects across multiple internal and contract manufacturing locations.
- Demonstrated understanding of specific global regulatory requirements applied to product transfer and process improvements.
- Excellent written and verbal communication skills.
- Strong analytical thinking and problem solving ability to facilitate resolution of both business and technical issues.
- Well- developed interpersonal skills (leadership, integrity, team orientation, flexibility and creativity).

The position requires up to 50% of international travel.

what do we offer?

As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some nice extra's like:

- Meal vouchers of €7
- Net representation cost of €50
- Hospitalisation insurance
- Car + fuel card OR home-work compensation
- 32 holidays
- End-of-year bonus
- Pension plan
- ECO vouchers
- Opportunities to follow training

And on top of this you'll improve your ……………… skills and become an even bigger expert!

summary
function
quality and environment specialist (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
reference
CXRSP-73126
your Randstad contact
Laurence Teerlynck
laurence.teerlynck@cx.ausy.be 03 201 39 26
03 201 39 26