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Senior Engineer of Process Development and Manufacturing

3 months ago

Alachua, United States Ascend Advanced Therapies Full time
Job DescriptionJob Description

The Sr. Process Development and Manufacturing (PDM) Engineer will be responsible for performing Upstream process development and manufacturing activities, working increasingly independently toward minimal supervision, and on a timely basis, in order to achieve department and/or company goals. This role will report to the Manager of Process Development Upstream.

Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.

Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.

Responsibilities:
  • Plan and execute upstream unit operations for the development and optimization of process unit operations. These operations may include seed cultures and cell culture expansion in both adherent and suspension platforms, , and scale-up (bioreactors).
  • Perform upstream unit operations in support of GMP manufacturing campaigns.
  • Support execution of upstream unit operations as needed.
  • Collect, record, analyze and summarize data in the course of biologics production and processing.
  • Trend in-process manufacturing data to monitor process control and support campaign summary reports.
  • Familiarity with modern protein, viral or vaccine production/purification methods.
  • Support process development and in-house manufacturing activities for generation of viral vectors for non-GLP and GLP study protocols.
  • Assist in maintaining laboratory/manufacturing supplies and equipment.
  • Author and revise relevant documentation such as standard operation procedures (SOP’s), work instructions (WIS), specifications (SPC), protocols (PRO), reports (RPT), forms (FRM) including production/batch records in support of bioprocessing unit operations associated with biomanufacturing campaigns and process development activities.
  • Maintain documents in accordance with GDP and other relevant Quality standards.
  • Documents manufacturing process deviations, conducts impact analyses, risk assessments and root cause analyses and drafts corrective and preventive action plans.
  • Advanced proficiency in basic biological techniques, methods and guidelines relevant to a biological lab.
  • Working knowledge of manufacturing industry standards in Quality cGMP experience a plus
  • This job description is subject to change at any time.

Requirements

  • Bachelor’s degree in an engineering discipline or other relevant scientific discipline.

Additional Qualifications
  • PDM Engineer I: zero to one plus (0-1+) years of experience preferred.
  • PDM Engineer II: two (2) years of experience or a Master’s with no experience.
  • PDM Engineer III: five plus (5+) years of relevant experience or a Master’s with three plus (3+) years of relevant experience.
  • Sr PDM Engineer: eight plus (8+) years of relevant experience or a Master’s with six plus (6+) years of relevant experience.
  • Course work and/or working knowledge of aseptic technique, cell culture and bioreactors theoretical principles and their application to process development preferred.
  • Experience with Quality Management Systems and Enterprise Resource Planners
  • Familiarity with design of experiments (DOE)
  • Programming experience in Wonderware software a plus
  • Vaccine or viral vector experience a plus
  • Understanding/working knowledge of Microsoft Word, Excel and PowerPoint
  • Excellent communication skills, both written and verbal

Benefits

  • Annual bonus
  • 401k
  • Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
  • 20 days PTO
  • 5 days Sick leave
  • 6 weeks Parental Leave

Company Values:

Aim Higher – Our motto and values. 

  • Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
  • Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
  • Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.

To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together