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Job details
Growing biopharmaceutical company seeks experience R&D leader with ADC expertise
This Jobot Job is hosted by Hunter Prater
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Salary $170,000 - $225,000 per year
A Bit About Us
Our client is a growing biopharmaceutical company that specializes in the ADC and mAb space.
Why join us?
Medical, Dental and Vision insurance
Annual Bonus
Company paid holidays
Generous PTO
401k with company match
Job Details
Scope of Function You will provide strategic leadership and direction for the department, driving innovation and excellence. This role involves defining and executing client projects that require process development, method development, and optimization. The focus will be on developing processes and methods that are transferrable to GMP operations and meet client goals and objectives. The position includes direct management of protein chemistry and bioconjugation teams and providing SME input across the MSAT/PD organization. Additionally, this role involves direct client and market interface through the development of white papers and thought leadership articles to demonstrate the company's technical and scientific capabilities.
Specific Duties
Serve as a member of the senior leadership team, contributing to the successful execution of projects and tech transfer into manufacturing, strategic scientific direction, monitoring industry trends, and providing insights into future business trends and requirements.
Ensure development of phase-appropriate drug substance processes for a portfolio of monoclonal antibodies, bispecific antibodies, cytokine fusion molecules, and other recombinant therapeutic proteins, including cell banking, upstream cell culture, and downstream purification. Develop synthetic routes/processes for bioconjugates for multiple applications, ensuring scalable, safe, and regulatory-compliant processes.
Contribute to planning synthetic routes for chemical synthesis projects in bioconjugation, ensuring bioconjugation processes control for API integrity as required by cGMP, ICH, and FDA regulations, suitable for formulation via formulation development activities.
Lead a cross-functional team of scientists in the design, optimization, and development to deliver mechanism-of-action and structural biology insights to advance client development projects.
Identify opportunities to streamline CMC development by integrating leading scientific approaches and working cross-functionally with MSAT, Manufacturing, Quality Control, and Quality Assurance to evaluate and implement these strategies to advance client projects.
Lead and mentor scientists in upstream, downstream, and bioconjugation processing, fostering a culture of scientific excellence, collaboration, and accountability within the Biologic Process Development team.
Author and review relevant sections of white papers, thought leadership articles, regulatory filings, IND/IMPD, BLA, etc.
Stay abreast of the latest advancements in research, therapeutic modalities, and industry trends, integrating new knowledge into Biologics Process Development strategies and programs.
Establish strong partnerships with key academic institutions, research organizations, and industry partners to access novel technologies, capabilities, and intellectual property.
Represent the company at
scientific conferences, industry events, and client meetings, showcasing expertise and fostering strategic relationships.
Ensure compliance with relevant regulatory guidelines, quality standards, and safety protocols in all R&D activities, maintaining the highest levels of integrity and ethical conduct.
Education And Experience Required
MS/Ph.D. in Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field; MBA or other advanced degrees preferred.
Minimum of 10 years of progressive leadership experience in the biopharmaceutical industry, with a focus on antibody processing and bioconjugation research and development.
Proven track record of successfully leading process development teams and driving the development of novel therapeutics from concept to commercialization, preferably in the conjugation space.
Deep expertise in bioconjugation technologies, including antibody engineering, linker chemistry, payload conjugation, and analytical characterization.
Strong understanding of preclinical and clinical development processes, regulatory requirements, and CMC considerations.
Exceptional communication, negotiation, and presentation skills, with the ability to engage and influence stakeholders at all levels of the organization.
Strategic thinker with a results-oriented mindset, capable of translating scientific insights into actionable strategies and operational plans.
Demonstrated ability to thrive in a fast-paced, dynamic environment, managing competing priorities and driving projects to successful outcomes.
Collaborative leader with a passion for mentorship and talent development, fostering a culture of innovation, inclusion, and continuous learning.
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Seniority level
Not Applicable
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Nanotechnology Research, Research Services, and Biotechnology Research
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