Formulation Associate - Northwest Indianapolis
- Immediate Opportunities - Life Sciences
- Indianapolis, IN, USA
- Full Time
Formulations Associate – Exelead
EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking an Formulation Associate.
This early-career position will be responsible for key formulation/engineering support primarily dedicated to bench-scale formulations and process development activities associated with sterile injectable drug products, particularly liposomes and lipid-based formulations. The primary task would be to plan, support and execute experiments with the aim of optimizing processes for scale-up and/or transfer to the cGMP environment within the constraints of timelines and under minimal supervision by senior scientific staff. A person with an innate scientific curiosity and keen observation skills will have the opportunity to impact the development of advanced medicinal prototypes for innovative drug delivery approaches. Additionally, the job responsibilities would include significant technical collaboration with the manufacturing and analytical technical services department as well as technical support for current process and product investigations.
Major Position Activities & Responsibilities:
• Execute developmental and investigational tasks through Quality by Design (QbD) approaches utilizing DOE principles. Associated tasks include formulation development, process design and engineering, equipment specification and engineering, data collection and analysis, generation and testing of critical process parameters (CPPs) to match the critical product attributes (CPAs) of the final drug product.
• Provide technical support via lab-scale execution for the manufacturing processes, including process investigations, process changes, and technical transfer and scale up of new product introductions. Adapt formulation solutions to complex products through guidance from senior scientific staff and collaborators
• Develop efficient, appropriate formulation procedures and Standard Operating Procedures (SOPs) for new equipment/processes as well as update of existing SOPs.
• Partner with the analytical technical services group to perform sample analyses in support of formulation development, in-process sampling and stability testing of final drug products/samples.
• Present quality written documentation, notebooks, methods, data reports and summaries. Report and treat data with a high level of integrity and ethics
• Discuss routinely with supervisor, project manager and peers the status of the assigned programs and potential problems. Communicate effectively on research results, issues, and plans.
• Conduct laboratory operations in a safe manner. Maintain compliance with the Chemical Hygiene Plan. Exhibit safety awareness and safe work practices.
• Follow responsible actions regarding chemical disposal in close collaboration with the EHS staff. Maintain compliance with appropriate SOP's.
• The person may also be expected to interface with external clients and contractors in support of existing projects.
• Performs special projects and other duties as assigned.
• The individual will be responsible for support of varied facility projects, including preclinical, clinical and commercial product tech transfer and development - no limit in value. The individual will be required to work in a project-defined team comprised of personnel from multiple departments as well as outside contractors. Project reporting is a dotted line structure with respect to specific project responsibilities only. Responsible for no direct staff.
• BS/MS in Chemical Engineering/Biochemical Engineering/Bioengineering. Other scientific disciplines including Polymer Science/Materials Science also acceptable.
• Strong problem solving skills and proficiency in general wet chemistry techniques and hands-on skills.
• Excellence in collecting data and accurately maintaining laboratory notebooks.
• Advanced computational skills with spreadsheets, word processing and databases.
• Strong verbal and written communications skills are required.
• Employee must be self-motivated, highly organized, and conscientious.
• Effective interpersonal skills are required to interface with internal and external clients as well as outside contractors.
• Must be able to work and make decisions independently as well as with a team.
• Must be able to work in technically demanding situations.
• Must be well organized with excellent time management skills to effectively coordinate multiple projects concurrently.
• While performing the duties of this job, the employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and peripheral vision.
• Employee must have sufficient mobility to work in a process environment. The employee may be required to climb stairs and ladders to perform the functions of this job.
• 0-3 years of experience in pharmaceutical process and formulation development or academic research activities in planning and executing protocols.
• Proficiency in the use of LIMS, Minitab
• Ability to independently perform root cause analysis for investigations
• Experience with statistical designs of experiments (DOE) methodology.
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