Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
At our plants in Halle/Westphalia and Bloomington/Indiana, we produce drugs for the treatment of various cancers and other life-threatening diseases.
In the role as a Manager (m/w/d) Analytical Services New Business, your overall focus is the management of analytical services in manufacturing projects, including method validation, documentation, client coordination, and audit support.
In your new role, you will be empowered to:
- Responseability for the project management of analytical services for the new business
- Validation, Transfer and Verification of analytical methods for contract manufacturing projects
- Preparation of analytical documents (test methods, specifications, protocols, plans, reports) for contract manufacturing products and raw materials
- Planning and support of stability-, compatibility- and other analytical studies
- Pharmaceutical evaluation of the above-mentioned activities within the project management team
- Support of analytical deviation investigations with respect to risk assessment, root cause analysis and corrective/preventive actions
- Processing of client requests
- Implementation of client requirements regarding analytical issues
- Cost calculation of analytical services
- Project management of analytical services (responsibility for timelines, milestones and costs)
- Representation during audits and client visits
What you'll bring:
- Degree in Applied Chemistry or Pharmacy with a license to practice as a pharmacist
- Minimum 1 year of experience in pharmaceutical production, development, and testing, particularly of parenteral products
- In-depth expertise in analytical and pharmaceutical chemistry; good knowledge of analytical microbiology
- Strong understanding of GMP guidelines and international pharmaceutical regulations
- Proficient in Lean Management principles
- Highly self-motivated with the ability to manage multiple projects simultaneously
- Fluent in English, both written and spoken
- Proficient in MS Office applications (Word, Excel, MS Project)
Benefits:
- An attractive salary and 30 days' holiday
- Modern in-house canteen with attractive subsidy
- Job bike leasing
- Good transport connections and free employee parking spaces with e-charging stations at favourable conditions
- Free company sports, e.g. badminton, football and fitness classes
We offer interesting opportunities to committed and talented people. Gender, age, skin color, origin, sexual orientation and disabilities do not play a role - on the contrary: we promote diversity and believe that diversity is an enrichment.
We look forward to receiving the documents relating to your professional career directly via our online system.
If you have any questions, please contact Selin Sencan ([email protected]).
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: Privacy Policy (DE) — Simtra BioPharma Solutions
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What We Do
As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach. Pharmaceutical and biotech companies partner with us when they face formulation challenges, clinical supply hurdles, surges in demand due to market fluctuations, or risk mitigation concerns. Our teams are driven to offer our clients tailored and versatile solutions to help them bring their products to market so they can get to the patients who need them. (Simtra is a tradename of Baxter Oncology GmbH and Baxter Pharmaceutical LLC)
