Lead Production Chemist

Merck•Madison, WI

5d•Onsite

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. JOB SUMMARY For over 25 years, Mirus Bio pioneered the manufacture of transfection reagents and proprietary technologies for nucleic acid delivery applications. Despite our extensive experience, we pride ourselves on maintaining the spirit of a startup. Our dynamic and forward-thinking approach has allowed us to stay agile and adapt to emerging trends. Our work is technical and cutting-edge, and we promote a culture that encourages creativity, initiative, responsibility, and respect. Our team members are engaged and motivated by the desire to support our customers to practice good science to generate strong results. Mirus, together with MilliporeSigma, is establishing the future of science and medicine by developing products that enable researchers within the cell and gene therapy space. Mirus Bio is seeking a full-time onsite Lead Production Chemist to synthesize critical compounds for Mirus Bio’s product portfolio including in vitro transfection reagents, nucleic acid labeling reagents, and accessory products. This individual contributor position will take a Lead role for the Production Chemistry Team. This is a divided role with approximately half of the time spent in the laboratory performing hands-on synthesis of Production Chemistry compounds. The other half of the time will be spent as the Subject Matter Expert who is also responsible for Raw Material Tech Transfer, flexing as required. This position will report to the Production Manager. This role is a part of a dynamic and fast-paced environment that collaborates closely with Production, Quality, Product Management, Project Management, and R&D Departments in a small start-up style environment.

Requirements

Bachelor’s Degree in Chemistry or related discipline (Master’s or Advanced Degree preferred)
At least 8 years of laboratory working experience, with a minimum of 4 years of relevant experience synthesizing and characterizing organic and/or polymer compounds
At least 2 years of experience working under the oversight of a Quality Management System.
Ability to work productively in a team environment including influencing actions and driving results.
Ability to work in a laboratory setting and lift 35 lbs. occasionally. Repetitive motion may be a work environment stressor for this position.
Hands on experience with a variety of analytical techniques, including NMR, GPC/SEC, fluorescence, FT-IR, MS, UV-VIS, HPLC, etc.
Excellent verbal and written communication skills required.
Demonstrated ability to identify and solve complex technical problems.
Ability to travel independently 5% of the time, including overnight travel
Ability to drive a vehicle; Must have current and valid U.S. driver license

Nice To Haves

Previous experience working for a life sciences company and in a cGMP environment is preferred.

Responsibilities

Chemistry Subject Matter Expert (SME) who is responsible for the hands-on synthesis of lipids, polymers and small molecules for Mirus Bio products for both new product introductions (NPIs) tech transfers and the existing Mirus Bio product portfolio, with extensive knowledge on synthesis scale up technologies and techniques.
Core Project Team Member for the technical transfer of Chemistry Production to manufacturing partners. This includes being responsible for the process development at manufacturing partners and being the SME and Technical Owner of Raw Material GMP Processes and ongoing oversight.
Project Lead for the NPI raw material technical transfers from R&D to RUO Production Chemistry.
Lead Production Chemist owning, overseeing, and supporting multiple projects, manufacturing partner productions, RUO productions, and other activities in parallel. Adapts to changing priorities and works cross-functionally to ensure on time deliverables and while ensuring a balanced workload.
Technical support for the extensive characterization of compounds using various physical and chemical characterization techniques such gel permeation chromatography (GPC), dynamic light scattering (DLS), nuclear magnetic resonance spectroscopy (NMR), high performance liquid chromatography (HPLC), fluorescence, mass spectrometry (MS), infra-red spectroscopy (IR).
Problem Solving leader and SME driving advanced troubleshooting and cross-functional resolution of problems and improvements for both RUO and GMP Chemistry Production.
Thought Leader, Trainer, and Mentor for the Production Chemistry Team who is responsible for the engagement with Mirus Bio R&D Team for complex technical decision making.
Solid foundation in production documentation including updating existing documents and writing deviations as required.
Owns complex root cause analysis and drives continuous improvement for Production Chemistry.
Effective communicator working across multiple teams, such as R&D, Operations, Project Management, Quality, and Product Management, to ensure alignment.
Follow GDP and cGMP guidelines and ensure quality compliance.