Scientist - CMC Process Development

Job Type

Full-time

Description

VISA SPONSORSHIP NOT AVAILABLE

The Scientist, Process Development drives the design and scale-up of processes, instruments, and equipment from laboratory to manufacturing.

• Develops conjugation, purification, and UF/DF processes for GMP manufacturing of clinical candidates.
• Defines the approach to late-stage process characterization to define critical process parameters (CPPs) and processing ranges.
• Designs and carries out lab scale or pilot scale DOEs to implements process improvements or new recipes.
• Coordinates with vendors or process engineers to establish improved operating equipment specifications or new process equipment introduction.
• Supports protein characterization strategies and analytical method development.
• Authors internal technical reports and presents/publishes process achievements.
• Serves as Subject Matter Expert in drafting and reviewing CMC sections for regulatory submissions (IND/BLA).
• Collaborates with other team members on departmental plans and objectives.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Requirements

Education

• Bachelor's degree in Biochemistry, Chemistry, or a related discipline with minimum of 3 years or MS in related life sciences with a minimum of 2 years of industry experience.
• Hands-on experience with the development of downstream purification, and UF/DF processes, is required.
• Good working knowledge of analytical techniques, including CEX-HPLC, SEC-HPLC, RP-HPLC, and capillary electrophoresis, is required.
• Experience with protein conjugation (PEGylation) and Single Use Systems is preferred.
• Candidate should have experience in cGMP manufacturing of injectables.

Other Requirements

• Occasionally requirements of climbing, balancing, kneeling, crouching, crawling, and stoop.
• The employee may frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations will be made to enable individuals to perform these functions.
• Excellent verbal, written and organizational skills.
• Must be able to understand, read, write, and speak English fluently. Extensive time in laboratories is required.
• Standard office environment for deskwork.
• Significant amount of time doing computer work (reading, writing, reviewing, and editing documents).
• Ability to work under pressure and meet deadlines. Some travel may be involved.

Benefits:

• Medical
• Dental
• Vision
• 401K
• Commuter/Transit
• Student Loan Assistance
• Cell Phone Allowance