Senior Process Engineer
Company Summary:Aeglea BioTherapeutics, Inc. is an Austin, TX based clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer. The Company is developing pegzilarginase, its lead investigational therapy, for the treatment of Arginase 1 Deficiency, as monotherapy in arginine-dependent cancers and in combination with an immune checkpoint inhibitor for small cell lung cancer. In addition, Aeglea has an active research pipeline of other human enzyme-based approaches in both therapeutic areas.
Position Summary: Aeglea BioTherapeutics based in Austin Texas, is actively recruiting for a Senior Process Engineer. Under direction from the Senior Director of CMC, apply process engineering knowledge and understanding to help facilitate and support activities related to developing upstream and downstream processes, tech transfers, process characterization, and process performance qualification. This includes ongoing support and process monitoring while working with external contract manufacturing organizations.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
- Serve as CMC technical process owner for Aeglea products.
- Provides technical guidance and leadership to a cross-functional team working towards the commercialization of Aeglea products with the objective of delivering the highest quality with respect to the process and product while also looking for opportunities for implementing steps towards continuous improvement.
- Contributes significantly to the development of process improvements and efficiencies.
- Performs process analyses to identify risks and implement any steps that would mitigate any negative impacts to process performance.
- Looks ahead to potential failure points and implements measures that potentially eliminate that failure point.
- Establishes and maintains a key data set of process parameters/trends that form the basis of a living document spanning the project lifecycle. This data set becomes the technical source document that supports all process transfer activities, process characterization activities, and regulatory filings.
- Author CMC sections of regulatory submissions as appropriate.
- Utilizes strong written, presentation, and verbal communications to articulate the requirements for process development activities.
- Supports investigations of process deviations or product failures; may be involved as person-in-plant.
- Remain current with biotechnology manufacturing technologies and cGMP regulatory guidance.
Qualifications:To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education/Experience:The ideal candidate will offer:
- Doctoral degree (Ph. D.) and 1 years pertinent experience/ Master's degree (M. A.) and 2 years pertinent experience/ Fifth year college or university program certificate; and approximately 3 years pertinent experience or more/ Bachelor's degree (B. A.) from four-year college or university; and approximately 4 years pertinent experience or more.
- Years of experience, along with level of education will determine level of the role. The ideal candidate will have 2-4 years of relevant experience.
Knowledge, Skills and Abilities:
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals.
- Strong communication skills, ability to write and speak effectively; actively listens to others, and provides direct feedback
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to prioritize, organize and delegate assignments. Uses time efficiently by planning and executing on goal orientated tasks.
- Sets high standards to ensure the quality in work performed.
- Excellent people skills in regard to approachability, professional maturity, teamwork, networking, initiating and building relationships.
- Demonstrates upmost level of integrity.
- Accountability; takes responsibility for adhering to all company policies, procures and performance expectations
- Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to define problems, collects data, establishes facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc.
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally on occasion is required, it is anticipated that this will be up to 30% of work time.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 50lbs, less than 25% of the time.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
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