Scientist I, Upstream PD - Abzena : Job Details

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With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.The Scientist I leads and oversees the work of the Process Development (PD) Leads and Associates in the development of scalable and robust processes on accelerated timelines. The Scientist I has technical competency in support of daily operations through research in diverse biological processes.Responsibilities

• Executes assigned work with full understanding of and ability to apply principles, theories, and concepts in specialized areas of responsibility.
• Uses current scientific literature with the technical capability to select methods and techniques for obtaining solutions within broadly defined practices and procedures.
• Produces proteins using mammalian cell culture to support lead generation/optimization and preclinical studies.
• Produces proteins using mammalian cell cultures under cGMP standards and with cGMP standards and regulations in consideration for production of clinical trial materials.
• Participates in technical transfer of upstream manufacturing processes from clients and between Development and Manufacturing groups.
• Leads client projects including the planning, execution, and conclusions.
• Exercises technical discretion in design, execution and interpretation of manufacturing and production that contributes to project goals.
• Provides detailed observations, analyzes data, interprets results and develops scientifically-sound solutions.
• Acts as a Subject Matter Expert (SME) to train others in areas of expertise. Assists and offers guidance to the Process Development group and Manufacturing group as necessary to train on correlated processes.
• Oversees production schedules, materials, equipment and manpower requirements.
• Maintains records to comply with regulatory requirements and assists with in-process testing.
• Operates and ensures appropriate maintenance of production equipment as it relates upstream production activities.
• Troubleshoots processing problems, bringing unusual problems (e.g., potential deviations) to the attention of the supervisor.
• Initiates deviations, assess product quality impact, and propose Corrective and Preventative Actions (CAPA), as needed.
• Sets up and performs scale down models to assist with process validations and manufacturing investigations, providing analysis as needed.
• Prepares technical reports, summaries, protocols, batch records and performs quantitative analyses.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Organizes own daily workload schedule and relevant resource requirements.
• Operates with minimal supervision on complex systems and equipment.
• Mentors and leads the work of junior personnel in the field. Provides training to new personnel in specific technical processes.
• Supports project teams on multiple projects simultaneously.
• Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
• Develops effective working relationships with both internal and external partners.
• Operates to the highest ethical and moral standards.
• Complies with Abzena's policies and procedures.
• Communicates effectively with clients, supervisors, colleagues and staff.
• Participates effectively as a team player in all aspects of Abzena's business.
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
• Performs other duties as assigned.

Qualifications

• BS, MS, or PhD degree in applicable scientific field.
• Minimum of 9 years directly related experience with a BS degree; Minimum of 6 years directly related experience with an MS degree; Minimum of 0 years' experience with a PhD degree.
• Knowledge and skill of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization.
• Knowledge and skill in relation to cell culture process steps including cell banking, thaw and expansion, and production (batch-fed and perfusion).
• Knowledge of designing of experiments for increase productivity in relation to operation of multivariate experiments using the Sartorius platform ambr250 and stir tank vessels.
• Skill and knowledge of scaling up to 500 L or more in single-use technologies.
• Knowledge of quantitative and qualitative analytical methods and interpretation of analytical data.
• Ability to organize workload, oversee direct reports, and relevant resource requirements.
• Skill in leadership duties, to include time management and planning.
• Knowledge of products manufacturing following SOPs, batch records and working within a cGMP regulated environment.
• Ability to observe technical issues with troubleshooting knowledge of process and equipment problems.
• Ability to operate complex systems and equipment and optimize their use in manufacturing in accordance with defined goals.
• Knowledge of specific product-related operations in protein purification.
• Ability to mentor and train purification associates and leads in process transfer, scale-up, from scientific and engineering perspective.

$110,000 - $130,000 a yearFLSA: ExemptAbzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology
• IndustriesPharmaceutical Manufacturing

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