Senior Scientist (Relocation Assistance)
SENIOR SCIENTIST UPSTREAM
Position Summary & Role
The scientist reports to the Senior Manager of Biologics and performs method development, product and process development, scale up/scale down processing, and performing a wide variety of activities including but not limited to the following responsibilities.
Job Responsibilities (core responsibilities; include people management if applicable)
- Lead process definition and implementation activities for Biologics
- Focus on Upstream Process Development
- Develop and optimize production and process methodologies
- Represent the process development group in cross-functional program teams and translate project goals into actionable plans
- Manage and execute technology transfer of production processes from development labs to GMP facilities
- Identify and evaluate opportunities for process innovation and improvement for scaling up and scaling out processes
- Identify and/or optimize unit operations to improve robustness, cycle time, throughput, and cost while maintaining product quality
- Support implementation of novel process solutions
- Lead successful execution and analysis of process development and characterization experiments
- Prioritize work and leadership across multiple process development and manufacturing programs
- Interface directly with customers to evaluate requirements and identify opportunities within development programs.
- Collaborate with peer groups in other Franchises to develop best practices.
- Communicating technical information to internal and external partners.
- Writing and reviewing technical documents and regulatory submissions
- Tissue culture and maintenance of engineered cell lines
- Perform work using fixed-bed bioreactors and stirred tank reactors up to 200L in scale
- Perform work using fermentors ranging from 3L to 300L in scale
- Assist in data analysis related to upstream processes, assays, and experimental outcomes
- Developing upstream/downstream processes
- Assists in drafting and reviewing standard operating procedures, work instructions, test methods, material specifications, and process development production records.
- Maintenance of activity records, log books, and general inventories in designated laboratory areas following GDP standards.
- Perform general cleaning and sanitization of equipment and general production areas according to procedures.
- Contribute to validation protocols and reports.
- Assist in training of manufacturing personnel at time of design transfer
- Provide support to Manufacturing, Quality Assurance and other departments as needed.
- All other tasks as needed or assigned by supervisor
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)
- MS degree in microbiology, biology, molecular biology, biochemistry, chemistry, or related field and 4+ years of experience in laboratory sciences/biotech/biopharma. Ph.D. in same areas with relevant industry experience
- Experience in process development, testing or manufacturing of biologics
- Experience with data analytics/data mining, statistics, high throughput data analysis is a plus
- Extensive experience with experimental design, data analysis, organization and presentation of complex scientific data.
- The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
- Ability to lead, manage, and motivate a diverse team across various functions.
Other Ideal Personal Characteristics:
- Strong leadership, technical, communication, and organization skills in a teamwork environment
- Highly motivated individual
- Strong work ethic
This job requires the employee to perform the following physical activities:
- Repetitive motion
This job requires exposure to the following:
- Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
- Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
- Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
- Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
- Narrow aisles or passageways.
This job requires the employee to perform the following type of physical work:
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
- Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
This job requires the following visual acuity requirements:
- preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.