Senior Bioprocess Engineer

Senior Bioprocessing Engineer

Company

CuriRx, Inc. was founded in 2012 with the goal of creating new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars. CuriRx focuses on formulation and lyophilization development of biologics, small molecules, analytical development, and GMP manufacturing of biologics.

This is an outstanding opportunity for a motivated, career-minded bioprocessing professional looking to advance their career at a fast-paced, high-growth company. CuriRx goal is to provide large scale biomanufacturing in the next few years, and we are looking for the right person to help us achieve this vision.

Job Description

The Senior bioprocessing engineer will be responsible for creating and implementing cell line development, upstream bioprocess and purification process development strategies for biologics, eukaryotic, prokaryotic, and viral vectors. The right candidate will be a hands-on, technical lead and subject-matter expert (SME) in vector design, cell line development, media development, cell culture, purification process technologies, that are consistent with FDA, EU, and international agency regulatory requirements. This role requires a strong knowledge of non-GMP to GMP biomanufacturing processes, as well as experience across CMC functions with a focus on process development. The successful candidate will also have a breadth of knowledge in cell characterization methods, as well as biomanufacturing under cGMP, validation, Quality Systems, and regulatory requirements.

Duties and Responsibilities

• Manages and performs upstream and downstream process development, ensuring adherence to industry standards and regulatory guidelines.
• Develops biologics drug substance manufacturing processes, tech transfer, and scale-up.
• Conduct basic molecular biology, select and optimize vectors, cloning methods, stable cell line development, and bioreactor operations (scales ranging from 1L, 10 L, 50L or higher)
• Optimize cell culture parameters for high yield expression and purification
• Oversee the purification process using advanced equipment and columns at scales ranging from 1L, 10 L, 50L or higher
• Develop and maintain project plans, timelines and milestones for process development, non-GMP biomanufacturing.
• Leads process development for the clinical and commercial scale-up and transfers effectively if needed to a contract development and manufacturing organizations CDMO.
• Serve as the technical lead and subject-matter expert (SME) while collaborating with clients, internal teams, and external partners.
• Evaluate and develop new technical methodologies, unit operations, data analysis techniques, and risk management strategies.
• Utilize analytical techniques, such as HPLC, mass spectrometry, and plate readers, to assess product quality.
• Lead process automation and equipment validation activities
• Apply Quality-by-Design principles to enhance product and process development.
• Stay current on regulatory requirements, including Biologics License Applications (BLAs) and biosimilars, and assist in the preparation of CMC and regulatory submissions.
• Create, review, and approve development reports, technology transfer packages, development/manufacturing protocols, and batch records.
• Recruit, develop, and mentor staff, ensuring performance aligns with organizational goals and objectives.
• Coordinate cross-functional activities to ensure timely progress on projects, including procurement and resource management.
• Build and maintain relationships with external consultants and industry resources.
• Develop SOPs, guidelines, and other operational documentation.
• Present results and activity reports to clients.
• Develop and implement comprehensive risk management strategies to address potential challenges in process development, scale-up, and manufacturing.

The successful candidate will also have:

• Technical proficiency, scientific creativity, initiative, and independent thinking
• Excellent team and interpersonal skills
• Experience bringing products to commercialization.
• Demonstrated understanding of industry trends, practices, techniques, and standards
• Proven ability to drive strategy as well as lead cross-functional teams.
• Strong technical project management and/or project leadership experience
• Strong communication (oral and written) and organizational skills.
• CRO or CDMO experience
• Demonstrated experience in leading and mentoring talent.
• Creative thinking and strong problem-solving skills
• Ability to interact successfully with multiple cultures
• Strong attention to detail and ability to multitask and prioritize assignments

Required Qualifications

• Ph.D. (preferred) with 10-12 years of relevant industry experience; or equivalent.
• Supervisory experience.
• Strong proficiency with MS Office; general Windows/PC familiarity and technical savvy.

If you have the required experience and skills to succeed, and you are seeking a challenging opportunity in a growing company with a dynamic culture, send your resume.

CuriRx is an equal opportunity employer and supports workplace diversity, a reduced carbon footprint, and fun.