Scientist, Quality Control Analytical Development (6-month Contract)

Rentschler Biopharma; Milford (MA); On-site; USD 62,000 - 76,000; Full time

Job summary

Rentschler Biopharma, with a Milford, MA site, seeks a Laboratory Analyst to support qualification and validation of analytical methods for biologic drugs in a cGMP setting.

You will execute experiments for ELISAs and qPCR, participate in method transfer to QC GMP labs, and review SOPs while training team members. Strong molecular biology and analytical skills are essential.

Qualifications

• Bachelor's Degree in chemistry or a biological science with minimum of 5+ years of experience in a cGMP environment.
• Experience with Spectramax M5 or M2 plate readers and the associated Softmax GMP software.
• Strong understanding of molecular biology assays in support of the product quality testing for biologics.
• Experience with analytical characterization of biologics is expected.
• Strong organizational, time management skills, and ability to prioritize work to meet deadlines.
• Excellent communication and ability to train others as needed.
• Strong knowledge of quality requirements in pharmaceutical AD labs.
• Safe laboratory practices and standard precautions knowledge.

Responsibilities

• Support qualification and validation of analytical methods for biologic drugs and process-related impurities.
• Execute experiments for validation of ELISAs for residual HCP, residual protein a, and relative potency assays and qPCR.
• Collaborate with a group of scientists to perform analytical method development, qualification, or validation under cGMP with QC.
• Apply biology expertise to the analytical development team across the lifecycle of procedures.
• Participate in technology transfer of analytical methods into QC GMP labs; method transfer/validation/development.
• Review and revise SOPs; author reports, protocols, and other documentation.
• Collaborate with labs to prepare methods for transfer to QC GMP labs.
• Provide training and work direction for group members.

Skills

Molecular biology

qPCR

SOP documentation

cGMP

Education

Bachelor's degree in chemistry or biological science

Tools

Spectramax M5

Spectramax M2

Softmax GMP

Job description

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions - together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

Duties And Responsibilities

• Laboratory role to support the qualification and validation of analytical methods for biologic drugs and process related impurities
• Primary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR
• Work collaboratively within a group of scientists to perform analytical method development qualification or validation under cGMP in collaboration with the Quality Control unit
• Apply expertise in molecular biology, cell biology and/or immunochemistry to analytical development team across the lifecycle of the procedures
• Participate in the technology transfer of analytical methods into QC and analytical method qualification Method transfer, method validation, method development
• Review & revise SOPs and/or author reports, protocols & other documentation as appropriate
• Collaborate with other labs to prepare methods for transfer to the QC GMP labs
• Provide training and work direction for group members as required

Qualifications

• Bachelor's Degree in chemistry or a biological science with minimum of
• 5+ years of related experience (or master's degree with 2+ years of experience) in a cGMP environment
• Experience utilizing Spectramax M5 or M2 plate readers and the associated Softmax GMP software required
• Strong understanding of molecular biology assays in support of the product quality testing for Biologics drug substances/drug products
• Experience with analytical characterization of biologics is expected
• Strong organizational, time management skills, and prioritize work schedule to meet deadlines
• Must be able to communicate effectively with managers, peers, and clients
• Must demonstrate effectiveness in ability to train others as needed
• Strong knowledge and expertise of quality requirements pertinent to pharmaceutical AD labs
• Strong working knowledge of laboratory safety including standard precautions associated with
• Experience with drug substance, drug products, intermediates, as well as experience with monoclonal antibodies is desired
• Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus
• Computer skills to include full competence with Microsoft Word, Power Point & Excel

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

Physical Requirements

• Frequent lifting up to 10 lbs.; frequent standing/walking
• Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods
• PPE as required

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Base Pay Range

$45/hr - $55/hr

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The salary pay range is subject to change and may be modified at any time.