Sr./Principal Scientist, Downstream Process Development

JOB SUMMARY

The Sr/Principal Scientist, DSP will direct the development and establishment of processes in Process Development.  This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal and external stakeholders.

JOB RESPONSIBILITIES

• Accountable for supporting the establishment of downstream vector platform from small scale through intermediate scale (50L) for adeno-associated virus, lentiviral and retroviral vector processes.
• Monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.
• Support process optimization efforts leading to increases in process robustness, cost reduction and improvements in viral yield and purity.
• Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members.
• Frequently communicate with external clients to design experiments and report out on generated data
• Maintain open communication via one-on-one and team meetings.
• Stay current with relevant technologies and client/industry including identifying new approaches.
• Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies.
• Develop appropriate and detailed SOP and BPR for downstream processes including equipment and system use
• Responsible for the process transfer from/to clients and to in-house manufacturing team(s).
• Maintain external technical relationships and collaborate with equipment and material suppliers.
• Serve as process SME for client-facing and internal programs.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PAY RANGE
The annual salary range for this position is $120,000-$170,000.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment 

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.

Lifting

• Frequently lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

Pay Range:
The annual salary range for this position is $100,000-$130,000.