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

• Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data
• Works collaboratively with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals
• Support Product Release activities ensuring timelines are met
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Identify and resolve issues with assistance from Data Review team
• Review of LIRs
• Support all data integrity initiatives and strive for right first time
• Make daily decisions about the quality of data based on biochemical knowledge and compliance background
• Revise, create SOPS and/or test forms as required
• Assists with metrics for trending and reporting as required, stability and QC analytical data
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Exceptional communication and interpersonal skills
• Assists in training of new hires and retraining of QC laboratory staff, as needed
• Assist/mentor QC new hires on cGMP/GDP
• Strong knowledge of QC analytical equipment and software required
• Strong communications skills – written and verbal
• Able to prioritize workload to meet stringent timelines
• Provide timely status updates to Management upon request
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Performs other duties as assigned

Qualifications

• B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
• 3+ years in a cGMP analytical laboratory environment
• HPLC, PA800, CS2500, SDS Page
• LIMS, EMPOWER
• cGMP experience

Working Conditions

• Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements
• Will interact with other departments
• Pace may be fast and job completion demands may be high
• Not a hybrid position, work must be performed on site

Physical Requirements

• May be required to stand for long periods of time while performing review of lab logbooks, equipment, lab documentation
• Must be able to walk distances between labs, offices, departments
• Must be able to work safely in a lab environment
• PPE as required