Senior Specialist External Manufacturing - Sterile Technical Operations (m/f/d)

Job Description

Do you have aBachelor’s or Master’s degree in Chemical Engineering, Chemistry, Biotechnology or other Engineering/Science related Disciplines and at least 4 years of experience in support of specific areas such as Sterile Processing, Tech Transfer or Validation or Operations. Do you have an understanding and application of principles, concepts, practices and standards that govern the manufacturing of sterile products? Do you have the ability to work effectively across boundaries to build strong collaborative relations with other internal Technical Operations, Sterile, External Services partner groups, Drug Product Sites and external partners? We are looking for you…

For our location Heist-op-den-Berg (Belgium) we are looking for a:

Senior Specialist External Manufacturing - Sterile Technical Operations

This role includes less than 10% travel throughout Europe.

About the position

The Organon S&T PTO (Science & Technology Pharmaceutical Technical Operations) External Manufacturing Sterile Organization is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture at contract manufacturing sites in Europe. This position is located in Heist-op-den-Berg (Belgium). The position is an exciting opportunity to work with key strategic external manufacturing partners and work on high visibility network initiatives with direct access to senior management. You will be responsible for driving change in sterile manufacturing, managing risk platforms and participating on global center of excellence technical teams. You will have upward growth potential and the opportunity to manage many different sterile/ non-sterile products and areas.

You will report into the Director S&T PTO.

Welcome to our team

The international S&T PTO Team consists of one Director, one Associate Directors, and two Senior Specialists, who all report to the Director. Each employee is working with the cross-functional team as TechOps Lead and regularly report to the team lead for TechOps topics of external manufacturing partners.

Main Responsibilities

• Manage the technical interface between Organon and key strategic external manufacturing partners in the sterile/ non-sterile DP, Formulation, Filling and Packaging.

• Provide technical solutions to complex technical problems and projects.

• Lead and execute technical transfers of a manufacturing process to support Supply from Commercialization to an external partner and other scenarios.

• Lead the technical interface with the external partners in the area of process support to aid in the resolution of production issues that could impact Supply and also to provide guidance on process optimization.

• Manage technical issues relating to the global external manufacturing of commercial Drug Product (Sterile & Non-sterile).

• Provide a single point of technical contact to assigned EP’s, impacted Manufacturing Division sites and Commercialization.

• Drive change (both internal and external) ensuring state of the art technology and processes are implemented and maintained.

• Lead to resolve technical issues relating to a product line or major technical projects within Technical Operations.

• Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing, i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation, continued process verification etc.

• Lead and act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.

• Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.

• Lead critical technical projects relating to the manufacturing of commercial drug product (Sterile/Non-sterile).

• Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPAs and change controls.

• Coordinate and manage risk assessments and develop solutions to complex issues that require a high degree of ingenuity, creativity, and innovation.

Your profile

• Bachelor’s or Master’s degree in Chemical Engineering, Chemistry, Biotechnology or other Engineering/Science related Disciplines.

• At least 4 years of experience in support of the specific areas like Sterile Processing, Tech Transfer, Validation or Operations.

• Understanding and application of principles, concepts, practices and standards that govern the manufacturing of sterile products.

• Ability to work effectively across boundaries to build strong collaborative relations with other internal Technical Operations, Sterile, External Services partner groups, Drug Product Sites and external partners.

• Strong knowledge of Quality systems (Change control and Deviation), Drug Product Manufacturing and Validation.

• Proven analytical and technical problem-solving abilities.

• Demonstrated strategic ability to develop innovative solutions for undefined problems and business processes to meet the needs of key stakeholders and project sponsors.

• Strong influencing skills and the ability to excel in working on cross-functional, cross-company, global teams.

• Strong technical and leadership skills, strong business acumen and strong interpersonal and communication skills.

• Ability to work both independently and as a part of a team, using strong collaboration skills.

• Demonstrated effective written and verbal communication skills; ability to influence peers.

• Excellent command of English (both written and oral).

Preferred Experience and Skills:

• Experience related to non-sterile manufacturing (Ointments, Drops, Syrup, and Tablets).

• Experience working with external contractors/ suppliers with demonstrated use of interpersonal skills to build strong technical relationships.

• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary.

• 40 days of annual leave.

• Attractive collective health care insurance package with considerable reduction rates.

• Solid Pension Plan.

• Incentive Plan/ bonus.

• Travel allowance for commuting.

• Numerous training, coaching and e-learning modules for long term job opportunities and development.

Who we are …

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.

Our Vision is clear: A better and healthier every day for every woman.

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.

At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R504515