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Senior Manager of Process Chemistry

Mironova Labs

This is a Full-time position in Fairfield, NJ posted February 22, 2021.

Title: Senior Manager of Process Chemistry Level: Managerial, Full Time Reporting Relationship/Reports to: VP of Operations Summary The Senior Manager of Process Chemistry is responsible for critical process R activity at Mironova Labs and will be essential in driving value and growth at the company.

The position requires a passionate, hands
– on expert organic chemist that thrives in small, dynamic group environment.

The role requires the candidate to be able to manage projects as well as work independently in lab.

The Senior Manager of Process Chemistry enthusiastically champions new innovation and process excellence through individual research initiatives as well active collaboration with all available internal and external technical resources to drive results in-line with Mironovas strategic business objectives.

Required Experience/Demonstrated Capabilities Extensive and proven experience with small molecule synthetic route design, process development, scale up and optimization conducting multistep and multiscale syntheses while optimizing the yields of each step en route to target APIs from gram to kg scale Demonstrated experience independently operating all common kilo-lab/pilot plant equipment (100L reactors, chromatographic equipment (i.e.

Biotage flash systems, prep-chromatography systems), Buchi rotoevaporators, etc)) Capability to manage and or work independently on all projects as assigned.

Highly proficient in chemical handling and safety best practices, including highly potent and hazardous compounds Demonstrated experience with technology transfer and outsourced work on process development, kilo-lab, pilot plant, and commercial scale production; preparation of CMC documents suitable for tech-transfer, regulatory support, and/or patent filings.

Intimate knowledge of literature and database search techniques Strong working knowledge of relevant industry software (SciFinder, Chemdraw, ELN, Microsoft etc) Deep working knowledge of quality regulations and principles (FDA, cGMP, ISO), familiar and working knowledge of all other relevant regulation for safety and compliance (EPA, DEP, OSHA, DEA) Qualifications Minimum Masters (MS) in Organic Chemistry with 6-8 years of process chemistry experience in an industry setting.

o Minimum 2-3 years experience API (small molecule) process development to pilot scale Expert knowledge of scientific principles, concepts and methods of synthetic organic chemistry are essential.

We require broad expertise in classical and modern synthetic methods and working knowledge of the latest developments in contemporary Process Chemistry Knowledge of spectroscopic methods for small molecule analysis (NMR, IR, UV, MS) and experience in analytical/preparative separation procedures (normal phase and reverse-phase HPLC) are necessary; experience in Flow Chemistry and chemical engineering a plusJob Requirements:Key Responsibilities Manage the development of efficient, scalable, safe, and robust processes/process-technology for the commercial production of Mironova small molecule products Working both independently and a technical team leader to oversee the design, planning, execution, and optimization of complex, multi-step organic syntheses for small molecule intermediates and finished API products Engage in all facets of process development from small scale synthesis to Pilot Plant manufacturing(100kg scale) o Literature research, Route scouting/design, analytical methods development, purification, equipment selection (isolation of standards/impurities) Independently conduct, manage, and direct bench scale experimentation and chemical development suitable for kilo lab, pilot, and commercial scale-up Participate as a key member of cross-functional development teams internally and externally to effectively meet business-critical objectives and timelines o Work with the VP of Ops to effectively collaborate with and manage all requisite supporting process/analytical chemists, engineers, and any/all other ad hoc resources (analysts, project managers, CRO/CDMO resources, technologists, and/or regulatory specialists) Act as the primary technical liaison to Production and Regulatory in support of technology transfer of processes from development to regular production, in compliance with applicable regulatory guidelines (i.e.

CMC, cGMP).

Realize continuous improvement by applying innovative chemistries, new technologies, and modern experimental design approaches that generate innovation in line with strategic business objectives.

Participate in strategic planning to achieve business goals in terms of supply chain management, risk mitigation, and new product development; Work with Mironova IP counsel to evaluate existing IP landscape, freedom to operate opinions, ensure non-infringement and strategically develop MNL patent portfolio to protect process technology assets Work with the Business Director in support of production financials, COGS analysis, etc Train technicians/operators and troubleshoot production Deviations as needed.