Marlborough, USA
10 days ago
Bioprocess Manufacturing Associate
Sartorius is seeking a Bioprocess Manufacturing Associate to support the clinical production of novel biological modalities such as cell & gene therapy, extracellular vesicles, and lipid nanoparticles with nucleotide cargos. The manufacturing of drug substance and drug product will use next generation bioprocessing platforms including continuous and integrated production for mAbs and viruses.

Sartorius is one of the world‘s leading technology providers to the life sciences and biopharma industries, and is actively shaping dynamic, innovative and high-growth markets. To drive the creation of new innovative solutions, Sartorius has formed an initiative to discover new trends and cutting-edge opportunities for rapid conversion towards next generation technology solutions. This exciting initiative enables the research, development and clinical production of novel modalities using next generation manufacturing platforms, in partnership with key customers.

The position will execute multi-modalities of GMP operations with critical thinking for safe and quality operational excellence. The entire team will work alongside Sartorius Corporate Research and Process Development to partner with customers for the unique opportunity to enable the production of novel modalities and processes.

The successful candidate will initially support the startup of the Manufacturing Space at 200 Donald Lynch Boulevard located in Marlborough, Massachusetts. This will require the candidate to work M-F supporting ongoing facility startup activities (CQV, Training Initiatives, GMP Operational Readiness). Following completion of the startup of the facility, the candidate will move to working a 4-day x 10-hour shift rotation. Flexible days/hours are sometimes necessary to accommodate project/production timelines when required.

What you will accomplish together with us:

You will initially work M-F supporting ongoing facility startup activities (CQV, Training plan, GMP Operational Readiness), then transition to a 4 -10’s shift structure (Sun-Wed or Wed- Sun).You will perform GMP MFG operations in all working areas of a typical GMP department (Solution Prep, US, DS, DP).In this role, you may function as process SME on manufacturing Unit Operations.One of your tasks will be to write and review operational SOP’s, work instruction and production batch records as required.You will create and sustain a culture of Safety and Quality focus within their team.You may review executed batch records and ensure compliance with cGMP guidelines.On an as needed basis, you will perform inventory management and control transactions.Active participation in daily GMP MFG huddle meeting.May coach, mentor and train operators on GMPs and unit operations.Support on floor technical transfer of client processes for GMP manufacturing.May interface with Client throughout Tech Transfer process as needed.Involvement in process improvement initiatives (KANBAN Management, GEMBA’s, 5s, etc.).

What will convince us:
Education:

You possess a High School diploma/GED with a minimum of 4+ years of GMP Manufacturing experience preferred.You possess an Associate’s Degree with a minimum of 2+ years of GMP Manufacturing experience preferred.You possess a Bachelor’s Degree in a scientific or technical field and a minimum of 1+ year(s) of GMP Manufacturing experience preferred.

Experience:

Experience with, and understanding of, biotechnology processes cGMPs and SOPs.Experience authoring SOP’s, batch records, Work Instructions or Job Aids.Strong computer, interpersonal and communications skills; written and oral.Ability to function in a fast paced, dynamic environment.Strong planning, organization, and prioritization skills.Leads by example, exemplifies positive behaviors, and is flexible.Ability to coach and actively manage team members on development, procedures, teamwork, and cGMP best practices.Identification with our core values: Sustainability, Openness, Enjoyment

What We Offer

As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring, leadership programs, LinkedIn Learning, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service

All qualified applicants will be considered for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

Please view equal employment opportunity posters provided by OFCCP here.

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Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.

We look forward to receiving your application.

www.sartorius.com/career

Sartorius is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. 

All employment decisions are based on valid job-related requirements. 

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by calling +1 631 254 4249 ext 8330 or via e-mail at accommodationrequest@sartorius.com
 

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers

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