Soortgelijke vacatures
Yacht Nederland BV- Utrecht
- Yacht Nederland BV
- Utrecht
A challenging Biotech Specialist position within our new state-of-the-art vaccine producing facility. Exciting new position to work in new team of biotech specialists, related to Drug Substance.
We have an exciting new job opportunity at our location in Boxmeer and are looking to hire a
Biotech Specialist
Welcome in our team
The Business Unit Drug Substance in Boxmeer is a new team, in the process of being built, and will be responsible for the manufacturing of one of our newest biological vaccines in our brand new and state-of-the-art production facility. This unit will consist of approximately 150FTE. Within the unit, the new Biotech Specialist team will ensure the drug substance is further manufactured and processed to the drug product in line with our incredibly high internal standards of quality and meets all regulatory requirements.
Purpose of the role
The Biotech Specialist plays a key-role in ensuring the biotech production of biological vaccines is executed in line with the guidelines/procedures and according GMP regulations. In this role the specialist will proactively initiate and execute quality improvements. And will advise on biotechnical drug product issues and quality and compliance related issues. The Biotech Specialist will report to the Senior Biotech Specialist in the team.
We have an exciting new job opportunity at our location in Boxmeer and are looking to hire a
Biotech Specialist
Welcome in our team
The Business Unit Drug Substance in Boxmeer is a new team, in the process of being built, and will be responsible for the manufacturing of one of our newest biological vaccines in our brand new and state-of-the-art production facility. This unit will consist of approximately 150FTE. Within the unit, the new Biotech Specialist team will ensure the drug substance is further manufactured and processed to the drug product in line with our incredibly high internal standards of quality and meets all regulatory requirements.
Purpose of the role
The Biotech Specialist plays a key-role in ensuring the biotech production of biological vaccines is executed in line with the guidelines/procedures and according GMP regulations. In this role the specialist will proactively initiate and execute quality improvements. And will advise on biotechnical drug product issues and quality and compliance related issues. The Biotech Specialist will report to the Senior Biotech Specialist in the team.
Your responsibilities
Main responsibilities
- Contribute to the Product Quality Strategy through translating attended possibilities for improvement. Is Subject Matter Expert;
- Steer and contribute, in co-operation with the business unit team and Quality, to the solution of product quality issues in the unit, based on pharmaceutical expertise and trending analysis. Responsible for the settlement of significant deviations;
- Evaluate on request the consequences of external guidelines, as well as initiate and develop biopharmaceutical policies and procedures. Approve (incidentally) deviations from approved policies and procedures and authorize GMP related. Draw-up SOP documents. Translate global guidelines into SOP’s;
- Advice the Senior Biotech Specialist and other relevant stakeholders, using specialized technical biopharmaceutical knowledge regarding the effect to product quality due to changes/deviations in process. Advices are in line with general standards of industry, governmental expectations and procedures and guidelines;
- Initiate and formulate proposals / business cases for quality improvement projects including deliverables and planning for the development and implementation of proposed improvements, in consultation with Quality, unit staff and external parties. Project management role in matrix organization;
- In line with Qualified Person guidance, quality procedures and guidelines ensure monitoring of the unit activities concerning compliance and take necessary action;
- Advice the unit regarding GMP inspections. Information and optimal support for the decision-making process regarding GMP inspections and observations;
- Monitor, initiate and ensure administration and implementation of data review and analysis (e.g. (Packaging) Annual Reviews, performance indicators) and documentation. Understanding of and insight in the historic and current status of data and documentation;
- Responsible for the realization of our corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
Your profile
Your profile
- Degree in (Bio)Pharmacy or related other science (e.g. process technology, Chemistry);
- A minimum of 2 to 4 years of relevant experience in biopharmaceutical and/or biotechnology industry (preferably in a sterile environment);
- Excellent knowledge of cGMP and strong focus on clients and quality/compliance;
- Excellent root cause analysis capabilities, Innovative abilities, creative, strong drive to improve;
- Good prioritizing skills and being able to make a just decision also in case of (time) pressure;
- Autonomous, assertive with an eye for details;
- Excellent Dutch and good English communication skills (verbally and written);
- Living at a reasonable distance from Boxmeer.
We offer
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.
For questions about this vacancy
Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
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 and a 3% year-end allowance;
- 35,5 days of leave;
- Attractive collective health care insurance package with considerable reduction rates;
- Solid Pension Plan;
- Annual bonus based on own and company performance
- Travel allowance for commuting
- Numerous training, coaching and e-learning modules for long term job opportunities and development
For questions about this vacancy
Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
Soortgelijke vacatures
Yacht Nederland BV
- Utrecht