Contract Biologics Process Development Scientist

Us Tech Solutions; Thousand Oaks (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

US Tech Solutions is seeking a biologics formulation and process development specialist to support drug product development in collaboration with a team of engineers and scientists. The role focuses on planning, execution, and documentation of studies to enable commercialization and lifecycle management of biologics.

The candidate will perform analytical testing, data analysis, and data-verification of protocols and reports while adhering to safety and regulatory requirements.

Qualifications

• Degree in Engineering, Chemistry, Pharmaceutics, or related discipline.
• 2+ years of relevant lab experience.
• Understanding of physical/chemical stability of proteins.
• Ability to learn new techniques and manage multiple tasks.
• Strong organizational skills and attention to detail.

Responsibilities

• Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.
• Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
• Evaluate process and product performance through analytical testing: pH, conductivity, osmolality, protein concentration, HPLC, CE, solid state characterization, particle quantitation/characterization.
• Data analysis and documentation/review in electronic notebooks.
• Author, review, and data verify protocols, reports, regulatory documents, etc.
• Communicate data in progress reports and presentations.
• Participate in cross-functional teams in a fast-paced environment to progress product development.
• Adhere to training, compliance, and safety guidance.
• Support lab operations and inspections as required of all lab-based staff.
• Work primarily onsite with remote work as appropriate to role and tasks.

Skills

Lab experience

Teamwork

Education

Engineering, Chemistry, Pharmaceutics, Materials Science or related discipline

Tools

HPLC

Densitometer

Viscometer

Tensiometer

Job description

US Tech Solutions is seeking a biologics formulation and process development specialist to support drug product development in collaboration with a team of engineers and scientists. The role focuses on planning, execution, and documentation of studies to enable commercialization and lifecycle management of biologics.

The candidate will perform analytical testing, data analysis, and data-verification of protocols and reports while adhering to safety and regulatory requirements.