Job Description: 

Prefer local candidates.

50% onsite 50% remote

Work Location: SMW, NJ or Seattle, WA
2nd of 2 positions

Position Summary:
Looking for an Engineer to join the Manufacturing Science and Technology Gene Delivery and Editing department. The position will be responsible for the routine MSAT support to our US CMO partners. This engineer will have responsibilities like an internal MSAT organization for viral vector manufacturing and fill/finish sites with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement. This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support. The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other groups and in-country affiliates in establishing manufacturing and technology capability, facility fit and design, equipment selection, and facility start up work.

Key Responsibilities:

• These include, but are not limited to, the following

• Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations and when needed, provide on-site technical process support of ongoing manufacturing processes.

• Create and revise technical documentation (e.g. changes controls, SOPs, and batch records)

• Perform deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenges deviations and drives them towards closure.

• Provide data collection, interpretation, and analysis on manufacturing and manufacturing support processes. Determine areas of opportunity, shifts and trends, and states of control

• Collaborate with cross-functional teams, including the CMO joint process team, Process Development, Manufacturing, Quality Assurance and External Manufacturing.

• Performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review and approval of production Master Batch Records.

• Perform detailed review of Process Development processes and generate technology transfer documents, including process monitoring (manufacturing data analysis, summary, and presentation) and authoring campaign summary reports.

• Develop simulated process models to estimate throughput capacity, resources and inventory levels.

Required Qualifications:

• OpEx and Lean Six Sigma project experience is strongly preferred

• Extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)

• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.

• Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.

• Experience with cGMP, ICH guidelines, PPQ (process validation), and working with a Quality organization.

• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

• Experience or knowledge of creating computer-based process models using process simulation software.

• Experience or knowledge of statistical analysis using statistical software packages.

• Able to creatively manage time and elevate relevant issues to project lead and line management.

• Strong scientific and technical writing.

• Detail oriented with excellent verbal and written communication skills.

• Ability to travel domestically and internationally.

Qualifications & Experience:

• MSc or BSc in Biology, Chemical Engineering, Biochemical Engineering or equivalent with 5+ years of relevant experience in process development or commercial manufacturing.

• Knowledge of CAR-T and/or lentiviral vector manufacturing is a plus.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Full Name: Savita Khashu

Email ID: savitak@askconsulting.com

Phone: 470-483-1052