Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

Duties And Responsibilities

• Perform testing following industry standard methods using e.g. HPLC/ UPLC / cGE Systems
• Create/revise SOPs, Protocols and Reports
• Practice safe work habits and adhere to safety procedures and guidelines.
• Perform maintenance and cleaning of laboratory equipment
• SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances
• Update and track metrics for trending and reporting; stability and QC analytical data
• Initiate SOP changes to streamline, standardize, and improve quality system processes
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Exceptional communication and interpersonal skills
• Assists in training of new hires and retraining of QC laboratory staff, as needed
• Performs other duties as assigned

Qualifications

• Bachelor's Degree in Life Sciences discipline
• Minimum 3 years’ experience in a cGMP analytical lab environment
• Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently
• Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
• Able to use and learn standard office equipment and technology with proficiency
• Familiarity with Empower Enterprise Software is advantageous

Working Conditions

• Laboratory environment working with chemical reagents and analytical equipment
• Normal office working conditions: computer, phone, files, fax, copier
• Personal Protective Equipment must be worn as required
• Minimum travel required
• Work is to be performed on site
• Possible weekend/off hours testing may be required

Physical Requirements

• Frequent standing/walking
• PPE as required
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds