Job Number: 21183731
Occasional weekend work required, paid as OT.
- As a member of the Biologics Development & Manufacturing group, the Assistant / Associate Scientist will provide technical and operational expertise and oversight to early-stage clinical manufacturing campaigns.
- The focus of this position will be on upstream operations and support of downstream operations in single-use manufacturing environment.
- Champion full capability of equipment capacity and manufacturing operations to lead and support manufacturing operations.
- Function as a core member during clinical processing.
- Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
- Adheres to the production schedule ensuring on-time, internal production logistics.
- Records production data and information in a clear, concise, format according to proper GDPs.
- Author manufacturing batch records, SOPs, material specifications, etc.
- Participate in technology transfers from Biologics Development and external partners to within network.
- Technology transfer will include providing decisions for manufacturing implementation of processes and communicating the decisions to the technology transfer team.
- Lead manufacturing investigations toward process impact assessments and ensuring timely completion and communications.
- Responsible for identifying appropriate CAPA(s) and implementation of them.
- Support routine data trending of manufacturing data to fulfill regulatory/compliance requirements.
- This includes authoring various technical reports.
- Leads process improvement efforts of significant scope, involving coordinating activities of other team members.
- Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline .
- Candidates will be considered for the applicable position based on education and level of experience.
- Assistant Scientist - BA/BS + 0-2 years relevant experience in manufacturing operations of Biotech / Biopharm industry .
- Associate Scientist BA/BS + 2-4 years or MA/MS + 0-2 years relevant experience in manufacturing operations of Biotech / Biopharm industry .
- Demonstrated skills in setup, operation, and control systems of single-use medium to large scale bioreactors and wave bioreactors .
- Demonstrated skills in formulation of culture media and buffer solutions.
- Hands-on experience in aseptic handling of mammalian cell cultures.
- Strong technical knowledge related to Cell Culture process and equipment (i.E., Bioreactors, wave reactors, media and harvest vessels, related analytical equipment, and process control software).
- Demonstrated experience in operational planning, operational execution, and troubleshooting.
- Good communication and project management skills appropriate for leadership of technology transfer projects.
- Experienced with working independently and representing the department to lead cross-functional project execution.
- Excellent technical writing skills, with significant experience writing standard procedures.
- Ability to work well in both individual and leadership capacities .
- Knowledge of DeltaV, cGMP, FDA/EMA regulations, Process Validation .
- Preferably experienced with training and leading peers on standard procedures.
- Preferably has proficiency in purification operations.
- Intermittent walking and sitting to perform job functions, however, ability to sit or stand for extended periods of time may be necessary.
- Physical dexterity sufficient to use computers and documentation.
- Ability to lift up to 25 pounds.
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
- Reagents, chemicals, and exposure to sanitization agents are expected.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Angie: angie@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02209
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE