Manufacturing Sciences - Downstream Scientist Team
The team is part of the Mammalian Manufacturing Department responsible for the Large Scale Manufacturing of Drug Substance for pre-clinical, clinical and commercial use.
The Downstream Scientist team is responsible for supporting our state of the art unit operations such as different chromatography techniques, virus inactivation/filtrations, UF/DF steps and filling operations etc. This mainly in single use equipment.
The scientists in the team are manufacturing project responsible participating in core teams when preparing a project for large scale manufacturing. During the batch execution the scientist team is responsible for supporting by the technician team performing activities on 3 different production lines working 24/7. The scientists also handles deviations, change requests, CAPAs, updating SOPs etc.
The department consist of 4 teams all headed up by Team Leaders/managers referring to the head of Department: An Upstream technician teams, two Scientist teams and a Downstream technician team. Organizational wise the Mammalian Manufacturing Department are approx. 100 employees and is part of Technical Operations.
Going forward the Manager Manufacturing Sciences - Downstream Scientists will also take part in building up the organization to support our new mammalian facility planed for operation by 2023.
As the Manager Manufacturing Sciences for the Downstream/Purification scientist you will be the direct leader of 16 scientists. All with an academic master or PhD background.
You will be responsible for:
- Manage performance and development of direct reports to ensure achievement of organizational and department goals for projects, deviations and CAPAs
- Ensure communications to stakeholders and change management using the ADKAR model.
- Planning- and coordination of work, board meetings and project staffing.
- People management, hiring and developing people, conducting mid- and end year appraisals.
- Secure prober training are in place, GMP compliance and safe work environment for the team.
- Provide leadership and take a leading role during FDA and EMA Inspection’s and during customer audits.
- Interact with costumers while handling above cases.
There is constant collaboration across the organization, and all employees have a professional and flexible attitude towards their work.
You will together with the Team Leaders and the head of department be part of the leadership team where operation, development and optimization of the entire department will be key.
Experience and competencies
The ideal candidate holds a MSc or PhD in downstream/purification or Chemistry/Biochemistry or similar and have previous been a leader preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences
- +5 years of experience from the pharmaceutical industry working in an GMP environment
- +2 years of leadership experience, preferably in manufacturing
- Scientific downstream/purification understanding is a must
- Strong communication skills (English)
- Strong collaboration skills
- LEAN oriented
- Can cope with a high work pace in a dynamic environment
- Structured and analytical oriented
Highly-motivated with strong sense of urgency, positive can do attitude and not afraid of rolling up the sleeves, in the process of maturing the organization.
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than December 10th, 2021.
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.