The Downstream development engineer will work primarily with scientists/senior research associates or engineers in the Downstream Process Development Pilot team to execute Pilot-scale experiments spanning across all phases of Biopharmaceutical development support new product development and support material supply demands. Additionally as a fundamental component related to the downstream process development the Downstream Process Development Pilot team will also ensure that these processes are predictable scalable and controlled. The position is to support the tech transfer of developed/locked processes from the process development team.
Daily Responsibilities Include:
- Works with departmental and/or cross-functional peers to execute on assignments under limited supervision.
- Prepares experimental protocols.
- Contributes significantly to project work which may include multiple projects within a functional area.
- Interprets data independently and contributes to technical reports
- Identifies complex technical issues and implements solutions under supervision
- Independently execute routine and complex operations and plans unit operations/experiments and draft support documentation (SOPs batch records and/or reports) with attention to details.
- Supports technology transfer through writing and consolidating technical documents.
- Coordinates within department as well as cross functionally with peers on projects.
Qualifications :
Education and Experience required:
- Bachelors degree in chemistry biology pharmacy engineering or related pharmaceutical science; 3 years relevant industry experience OR
- Masters degree in chemistry biology pharmacy engineering or related pharmaceutical science; 1 years relevant industry experience
- Must have experience with downstream purification process
- Must have experience Downstream activities include but are not limited to chromatography ultrafiltration/diafiltration TFF and/or depth/sterile/ filtration of non-GMP batches within R&D Pilot Plant (interface between lab-scale studies and full-scale GMP manufacturing operating at the 50-1000L bioreactor scale)
- Experience with AKTA Liquid Chromatography systems and Unicorn Software preferred.
Knowledge and Skills:
- Excellent documentation and organizational skills
- Ability to communicate proficiently and efficiently
- Time management skills effectively managing multiple priorities and outcomes of critical tasks
- Proficient in use of applicable lab equipment and operations and have an ability to independently interpret data maintain an organized lab area and thrive in a fast-paced team environment
- Experience troubleshooting of activities routinely performed in downstream processing (i.e. traditional and continuous chromatography UF/DF filtration column packing and buffer preparation)
- Practical experience around scale-up technology transfer and manufacturing support of large scale GMP operations is desired. Knowledge of upstream processing is a plus
- Experience with one or more of the following software: Solo VPE Microsoft Office JMP Viper Flow VPE Freezer Pro BioSMB PALL System Software and Pendotech System.
- Analytical and Problem-Solving Skills
- Ability to wear personal protective equipment such as safety glasses/goggles gloves shoes
- Comfortable working in Collaborative (60%) and Independent (40%) work environments.
- Ability to lift pull or push equipment requiring up to 75 lbs of force stand for 6 hours in a suite climb ladders and work platforms stoop or bend to check or troubleshoot equipment operations
- Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information :
What to Expect in the Hiring Process:
- 10-15 Minute Phone Interview with Region Recruiter
- 45-60 Minute Virtual Interview with Manager and/or Group Leader
- 45-60 Minute Site Visit to Meet the Team
The position is Full Time Monday-Friday 8 am-5 pm. Candidates currently living within a commutable distance of Lexington MA are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global award-winning insourcing solution that places our people at our clients sites dedicated to running and managing laboratory services while eliminating headcount co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise as well as HR and great place to work best practices to recruit hire train and manage highly qualified scientists to perform laboratory services using our clients quality systems and equipment.
To learn more about Eurofins Lancaster Laboratories please explore our website .
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time