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General Description:

This position reports directly to Manufacturing Science & Technology (MST) Team Leader and this position plays a critical role leading role of purification group. This is a leadership position within MST that requires advanced technical expertise in protein purification skills, included but not limited to chromatography, filtration (tangential flow, depth, viral and dead end) in addition to general knowledge for mammalian cell culture processes and/or, formulation, protein product quality attributes, and advanced data analysis skills.  Of equal importance, is the ability to develop rapport internal and external to MST.

This position plays a leading role of purification group in technology transfer, troubleshooting processes, building a detailed understanding of them, and driving process robustness by setting clear objectives and empowering their team.  This position involves close collaboration within MST, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups.  

Technical/Skills Required:

• Expertise in Green-Field Projects for Mab Facilities and Process Design / Development.

• Expertise in equipment identification/procurement as well as DQ, IOQ and Validation activities.

• Expertise with chromatography systems (AKTA), tangential flow filtration, analytical equipment.

• Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools.

• Experience with downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.

• Expertise with study design such as DOE and authoring of study protocols / reports.

• Good understanding of GMP requirements.

• Proven planning and data analysis skills, use of statistical software to analyze data

• Project management skills related to internal and external teams

• Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA.

Working Experience:

• Minimum of 8 years of experience, or 5 years of experience with an advanced degree, in the Life Science/Biotech industry

• Experienced in raw material characterization, biological manufacturing purification manufacturing development and production operations at various scales

• Familiarity with EMA and FDA regulatory requirements for process development submissions

• Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements

• Experience in effectively managing scientific groups and projects

• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment 

• Demonstrated skill in leading project teams tasked with resolving complex production related issues

• Good written and communication skills

• Familiar with software such as Microsoft Office including Microsoft Project, Visio, etc.

Physical Requirements :

• Must be able to stand for long periods, up to 8 to 10 hours/day

• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently

• Must be able to work scheduled 40 hours with the ability to work overtime as needed

• Must be comfortable in working in varying temperatures

• Frequent lifting, pushing, pulling, and carrying. Ability to lift up to 40 lbs

• Regular reaching, bending, stooping, and twisting

• Repetitive motion and substantial movement of the wrists, hands, and/or fingers

• Environment requires dedicated gowns, depending on area

• Work with hazardous materials and chemicals

• Willing to work any shift

Supervisory Responsibilities:

• Leading, mentoring and developing staff is a critical aspect of the role.

Computer Skills: MS Office and statistical software including but not limited to SAS JMP, Minitab, etc.

Other Qualifications: N/A

Travel: Some travel may occur as a result of duties assigned to the role

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.