Scientist III, Biologics Upstream Process Development

SUMMARY/JOB PURPOSE:

The Scientist III, Biologics Upstream Process Development will contribute to the development of cell culture processes and support technology transfer and manufacturing of biological drug candidates. Working under minimal supervision, the incumbent will apply technical knowledge in upstream/cell culture process development of biologics (therapeutic proteins, antibodies, bispecifics, ADCs, etc.) to support CMC development activities for pre-IND and clinical-stage programs.

The role requires strong hands-on laboratory skills and a solid understanding of upstream unit operations, including media/buffer preparation, cell thawing, passaging, aseptic sampling, and cell banking. The Scientist III will operate upstream equipment such as Ambr250 system, single-use bioreactors of various scales, and cell culture analyzers, and will assist in routine instrument maintenance and troubleshooting.

The incumbent will be responsible for documenting experimental results, contributing to drafting test methods and SOPS, and ensuring compliance with company and regulatory standards. Collaboration with downstream process development, analytical, and formulation teams is expected, and a general understanding of Biologics CMC is beneficial.

This position is lab-based and offers the opportunity to grow technical expertise while contributing to the advancement of Biotherapeutics programs.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Under minimal supervision, perform laboratory studies to support cell line development, upstream process development, and scale-up activities, including execution of upstream unit operations at pilot scale (up to 200 liters), and assist in technology transfer to external partners for clinical manufacturing.
• Collaborate closely with internal teams in downstream process development and analytical development to support CMC Biologics programs.
• Maintain complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training.
• Support routine lab operations, including inventory management of consumables and cleaning of glassware.
• Coordinate vendors' service calls for repair and maintenance of laboratory instruments, perform routine maintenance of laboratory instrumentation, and maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.
• Contribute to the development and maintenance of upstream process development and scale-up capabilities within the CMC Biologics team.

SUPERVISORY RESPONSIBILITIES:

• None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor's degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of three (3) years of relevant drug discovery/development experience; or,
• Master's degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of one (1) year of relevant drug discovery/development experience; or,
• Equivalent combination of education and experience.

Experience:

• Extensive experience in upstream (mammalian cell culture) process development and recombinant protein production up to 200 L bioreactor scale.
• Experience with harvest and clarification unit operations.
• Hands-on experience with upstream equipment such as Ambr250 system, single-use bioreactors of various scales, and cell culture analyzers.
• Hands-on experience with upstream unit operations including media/buffer preparation, cell thawing, passaging, aseptic handling (sterile connections and sampling), and cell banking.
• Experience monitoring cell growth kinetics, metabolite trends, and gas exchange profiles during mammalian cell culture processes.
• Experience collaborating with CMC downstream process development.
• Experience in technology transfer to external CDMSs preferred.
• Demonstrated capability to work independently on complex technical problems, effectively in cross-functional teams, and with external CDMOs and partners.

Knowledge, Skills and Abilities:

• Expertise in upstream (mammalian cell culture) process development.
• Broad and deep knowledge of CMC biologics, upstream processes.
• Ability to apply technical knowledge to CMC development and manufacturing for biologics across the product life cycle.
• Working knowledge of downstream process development, analytics, formulation development, and bioconjugation process development.
• Understanding of cGMP quality and regulatory requirements for CMC biologics preferred.
• Ability to multi-task in a fast-paced dynamic environment while delivering high quality work.
• Sets goals with understanding of priority and impact to the program, department and organization.
• Excellent interpersonal, presentation and written communication skills.
• Excellent organizational and documentation skills and habits.
• Creative thinker and complex problem solver.
• Environment: primarily working in laboratories.
• May involve routine exposure to biohazardous materials, brief periods in cold environments (e.g., cold rooms or freezers) and occasional lifting of items weighing up to 10 kg, in accordance with safety protocols.
• Limited travel required.

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DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.