Senior/Principal Scientist, Downstream Process Development

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Job description

About Laronde:
Laronde is pioneering a platform that offers a completely novel way of modulating human biology. Endless RNA™ (eRNA), invented at Flagship Labs, is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. It is persistent, non-immunogenic, allows for repeat dosing, and offers flexibility in formulation and delivery. Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. Laronde has raised a record breaking $440 Million in a Series B Financing to advance the development of its eRNA platform and a broad pipeline of programs across a number of therapeutic categories. The company is rapidly scaling to support the parallel development of multiple programs across many disease areas. To learn more, please visit the company's
website at .

About Flagship Pioneering:
Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $130 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Denali Therapeutics (NASDAQ: DNLI), Indigo Ag, Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology (NASDAQ: SANA), Seres Therapeutics (NASDAQ: MCRB), and Valo Health.

Position Summary:

Laronde is seeking a creative, motivated Principal Scientist to develop eRNA purification platform to enable both low vol. and HTP scale-out process and large vol. scale-up for IND enabling studies and clinical supplies. The candidate will develop purification approaches to produce drug substance of appropriate quality attributes. The candidate will interface with the Platform, Scale-out / Scale-Up process development team and Analytical development teams to enable harmonization of processes for scale out (preclinical test agent) and scale up (clinical supplies). The candidate will also investigate the scalability of the process and a path to establishing a platform process across all programs. We are searching for driven, enthusiastic and self-motivated individuals who can drive the various aspects of the platform.

Key Responsibilities:

• Lead scientists and research assistants to development of novel downstream eRNA purification platform to enable scalable and scale-out capability to deliver highly pure drug substance
• Manage direct reports to develop novel first in class purification processes to drive IND and clinical success.
• Design, lead and drive experiments for screening, optimization and scale-up purifications of RNA by leveraging DoE, chromatography and filtration separations including TFF
• Apply and develop state-of-the-art technologies and solutions using novel processes and translatable industries.
• Develop, refine and deploy unit operations for enzymatic reactions; characterize enzymatic reactions using first principles
• Lead the process development activities to support the scale-out efforts to develop reliable scale down processes for high-throughput construct screening experiments.
• Co-develop characterization methods with analytical team to assess quality of the material
• Write protocols and prepare reports and presentations that support drug substance and drug product clinical development.
• Troubleshoot lab workflows, maintain equipment and support IND enabling manufacturing batches
• Collaborate effectively across development, analytical and scale-out teams to drive scientific initiatives.

Qualifications:

• PhD 5 - 7 years of experience or BS + 12, MS +9 years industry experience or equivalent in bioengineering, chemical engineering, biology, virology, biochemistry or related field
• Development experience on novel therapeutics-focused technology platforms and modality is preferred.
• Experience delivering on strategic timelines and executing successful on corporate goals
• Expertise in nucleic acid synthesis, purification, enzymes, manufacturing, analytics and/or formulation
• Hands on experience using separation instruments like HPLC, AKTA and TFF
• Experience and/or understanding in nucleic acid chemistry, enzymatic reactions, PCR, plasmid processing and standard analytical techniques such as CGE is preferred.
• Eager to work with highly skilled and dynamic teams in a fast-paced, entrepreneurial and technical environment
• Strong written and verbal communication and highly effective collaboration skills across operations and development teams.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.