Are you interested to work for an innovative, dynamic, and future oriented start-up CDMO company?
We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.
Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organisation (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.
For our site in Hørsholm we are seeking a motivated, open minded and experienced person as Head of DS Manufacturing Facilities & EHS.
Role and Responsibilities:
- Manage, operate and maintain our cGMP compliant and safe Drug Substance (DS) manufacturing facility. Drives facility fit and continuous improvement in manufacturing of Live Biotherapeutic Products (LBP) for our customers. You will report to the COO.
Production, EHS & Facility Management
- Responsible for all activities in the GMP manufacturing facility including production, planning, new product introduction (in partnership with development), procurement, facility and equipment management and associated systems.
- Responsible for EHS oversight and systems management at Bacthera’s Hørsholm site.
- Responsible for Facility Management and Services at Bacthera’s Hørsholm site.
- Delivery of these responsibilities in accordance to cGMP and EHS regulations.
- Responsible and owner of the budget for the facility and its activities.
Team Management and Collaboration:
- Guide and lead your team (7) in accordance with Bacthera’s ambitions, strategy and deliverables.
- Responsible for the recruitment, onboarding, training and development of staff to deliver on the departments objectives and targets.
- Driving a culture of quality, operational excellence and continuous improvement in all areas of the department, striving to deliver to our customers right first time and on time.
- Drive collaboration and effective communication with all other departments and functions in Bacthera including development, DP Manufacturing, Quality, Validation and Qualification, ITS, business development, project management and finance.Commercial and
- Collaboration and interaction with our customers with respect to DS manufacturing, supporting the Project Management team in the delivery of customer programs.
- Work with our commercial team in putting together proposals and offerings for prospective customers.
- Masters (minimum) in the areas of Biotechnology, Engineering or Life Sciences
- 5-10 years’ experience in cGMP manufacturing of API / drug substance in the pharmaceutical sector, preferably in biopharma/biotechnology and microbial fermented products
- Experienced in managing a production team and a cGMP facility
- Experience identifying and implementing new strategic opportunities, such as facility or capability expansions.
- Strong Communication and Collaboration skills
- Fluent in English (speaking and writing)
- Occasional travel required (10-15%)
Application, contact and further information:
Are you interested to work for an innovative, dynamic, and future oriented start-up CDMO company? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your cover letter and CV to Beirholm Search, for any questions you are welcome to call. Hanne Beirholm tel. 29440080.
We are looking forward to welcoming you in our new production site in Hørsholm.