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Company

Original Job Post

Andelyn Biosciences · 1 week ago

Plasmid Process Development Senior Scientist - Fermentation

Columbus, Ohio Metropolitan Area

Full-time

Onsite

Senior Level

5+ years exp

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BiopharmaBiotechnology

H1B Sponsorship

Hiring Manager

Pamela Backus-Diggs

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Responsibilities

Devising and execution of various development projects both up- and downstream.

Developing fermentation production processes that can be scaled from sub-liter shake flask cultures to 200-L bioreactors.

Developing and reviewing procedures and Batch Record forms for fermentation processes.

Assisting in the technical transfer of fermentation processes from process development to research grade and GMP manufacturing.

Troubleshooting issues and trending Critical Process Parameters and Critical Quality Attributes.

Identifying and coordinating the development of experiments to fill knowledge gaps.

Providing leadership in daily operational activities related to the development of manufacturing processes.

Leading and supporting a diverse and collaborative team environment.

Working with vendors to design and source new materials.

Anticipating and troubleshooting issues with operations to avoid interruptions in production.

Working with management to answer client questions regarding their product.

Solving, correcting, preventing problems, and performing tasks as assigned by leadership.

Delegating tasks to junior staff.

Working to specific, measurable objectives requiring operational planning skills with little direct supervision.

Mentoring, training, and supervising junior staff.

Ensuring continuous improvement objectives are identified and met.

Ensuring new projects and technologies are sought for incorporation into the Plasmid area.

Exercising discretion, judgment, and personal responsibility.

Demonstrating a high level of integrity.

Maintaining compliance with applicable regulatory requirements for cellular and gene therapy products.

Performing in accordance with established policies, procedures, and techniques.

Documenting all development activities performed according to SOPs.

Making decisions based on established procedures.

Having fiscal responsibility.

Traveling infrequently.

Being moderately involved in audits, customer relations, inspection outcomes.

Influencing hiring, development, and related personnel processes.

Mentoring and providing professional development to staff.

Performing other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Prokaryotic cellsAseptic techniqueFermentationCell cultureLiquid separation techniquesFluid handlingPlasmid productionMicrosoft OfficeData interpretationRegulatory complianceDocumentationSOPsProblem-solvingCommunicationOrganizationProject managementAdaptabilityCollaborationClient focusAttention to detailHighly Regulated Fields

Required

Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred

Five years relevant (w/4 YR deg) OR two years (w/Masters)

Experience with prokaryotic cells is essential

Knowledge and experience in aseptic technique, fermentation, cell culture, liquid separation techniques, and/or fluid handling

Experience in plasmid production required

Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word), including data interpretation and reporting

Ability to work independently as well as collaboratively in a diverse and inclusive work environment

Must possess a client-focused mindset in daily tasks

Maintain compliance with applicable regulatory requirements for cellular and gene therapy products

Attention to detail in all job functions

Documentation of all development activities performed according to SOPs

Make decisions based on established procedures

Preferred

Experience in fermentation preferred

Experience in highly regulated fields preferred

Benefits

Medical, dental, and vision insurance plans

Paid Time Off

Company Paid Holidays

Life Insurance

401(k) Match

Short and long-term disability

Paid Parental Leave

Adoption Assistance

Tuition Reimbursement

Student Loan Repayment Assistance

LinkedIn Learning access

Employee Assistance Programs

Company

Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical company that delivers treatments and therapies for patients.

Founded in 2020

Columbus, Ohio, USA

201-500 employees

https://www.andelynbio.com/

H1B Sponsorship

Andelyn Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (3)