The Downstream Development Group is responsible for the development of downstream processes for clinical batches as well as the production of batches of purified protein for client evaluation.
Participate as a key member of a team in the development and implementation of scalable purification processes for the isolation, purification and characterization of recombinant proteins and antibodies from mammalian cell culture.
Specific Duties, Activities, and Responsibilities:
Take lead role in the development of chromatographic processes for the purification of proteins
Preparation of small batches of protein for client evaluation
Prepare non-GMP batch production records for the consistent production of purified protein at up to the 100L scale.
Act as technical support to manufacturing for transferred purification process.
Prepare technical transfer documents for transition of process from Non-GMP to GMP production.
Prepare and execute scale-down purifications to support viral clearance studies.
Prepare purification development and batch production reports.
Interact with clients to discuss project progression.
Other duties as assigned.
Advanced Delivery Technologies (ADT)
Baccalaureate degree in Biotechnology or related biology field with 10+ years of experience; or
Advanced degree with 5+ years experience.
Minimum 5 years experience.
Experience with Akta chromatographic systems
Experience with all major types of chromatographic separations.
Experience with SOP and BPR preparation and execution
Experience with processing large batches of protein (100's grams).
Ability to independently develop purification processes
Ability to provide technical direction to junior scientific staff.
Good oral and written communication skills.
Good communication and teamwork skills
Knowledge and experience in working in a cGMP environment is preferred.
Demonstrated ability to read, write, and speak clear English.
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening
Occasional bending, grasping, carrying, stooping, kneeling, crouching
Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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