Scientific - Assistant Scientist

100% onsite

Normal business hours

Position Summary

This position will directly support qualification and operational activities for the Reference Standard and Critical Reagent (RSCR) Group within the Global Quality Analytical Science & Technology (GQAST) organization. The primary role will function as a subject matter expert for biologics (large molecule) reference standards to support all aspects of qualifications, investigations, procurement, and inventory burn rate for the RSCR science and qualifications team.

Successful candidates will have a minimum Four years' experience in the pharmaceutical (large molecule) industry. A solid foundation in biologics manufacturing process development and exposure to biologic impurities within commercial manufacturing is preferred, but not required. Knowledge and experience with HCP Elisa, Residual DNA testing, Protein A testing, method development for biologics, and method validation and transfer. Experience working in a quality laboratory for clinical or commercial production of pharmaceuticals (large molecules) is a must.

A solid background in modern analytical techniques used in testing pharmaceutical products is essential. Previous experience in supporting testing related to analytical projects and / or analytical project management would be a benefit in this role. Familiarity qualifying reference standards and critical reagents is desirable, but not required. Knowledge of cell gene therapy practices is also desirable.

Key Responsibilities

This position will manage and oversee an aggressive portfolio of Client reference standards and critical reagents programs to meet project deliverables and timelines. Success in this role requires the ability to work well in team situations, well-developed multi-tasking skills, and the ability to operate well in a dynamic work environment. The candidate must embrace collaboration with stakeholders, customers, and team members, while operating with integrity, as well as seeking and participating in the continuous improvement of systems and culture. Closely monitor key aspects of the business such as inventory and burn rate analysis, and actively participate in investigations and providing documentation and expertise supporting BLA filings. They must thrive in environments with frequently changing priorities within a diverse / inclusive high-performance team. The position requires sustained, concise communication with departmental team leaders, project managers, Quality Assurance, and CMC Regulatory Affairs so a firm command of the English language as well as excellent verbal and written communication skills, and a knowledge of computer applications and data acquisition systems are essential.

Qualifications & Experience

Specific Knowledge, Skills, and Abilities :

• Bioscience professional proficient in a variety of bioanalytical techniques and knowledgeable in large molecule drug development.
• Industry experience in biotech / biologics or pharmaceutical analytical laboratory techniques, specifically working with reference standards and / or critical reagents is desirable.
• Must demonstrate teamwork, strong organizational skills, computer competency, and effective written and verbal communications within both structural and matrix organizations.
• To be successful in this role, the candidate must embrace collaboration with partners, customers, and team members, while operating with integrity, as well as seeking and participating in the continuous improvement of systems and culture.
• Prior experience in biotech or analytical laboratories, specifically for reference standard management / testing programs is highly desirable.

Education / Experience / Licenses / Certifications :

A BS / BA or Masters in biological sciences, chemistry, engineering or related scientific disciplines with a minimum of four years of experience in the biotech or pharmaceutical industry.

Physical Demands / Work Environment :

This is a support role for commercial and clinical programs, including lab work, office work, teleconferencing, computer work, and running / attending meetings.

On-site Protocol

Physical presence at the Client worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.