New Modality GMP Operations Lead - Marlborough, MA

As the New Modality GMP Operations Lead, you will be responsible for a team of Manufacturing Operators in a Clinical cGMP Manufacturing facility located at 200 Donald Lynch Boulevard, Marlborough, MA. This position will support the start-up activities and oversee the daily production plans within defined timelines and quality standards to meet.

What you will accomplish together with us:

Management            

• Management of a team of Manufacturing Associates and Team Leads in aseptic cleanrooms

• Manage and maintain accurate project and production plans, including schedule, resource, budget, contingencies and provide regular project status reports

• Strong planning, organization and multi-tasking skills with the ability to make decisions and work with minimal to moderate supervision

• Promote a working environment that encourages employee involvement to achieve operational excellence

• Works collaboratively with others to meet group and organizational goals

• Establish/support key performance indicators that inspire change and visibility to the team and leadership

• Routinely track, trend, and monitor processes with active data analysis to drive continuous improvement

Leadership

• Lead by example and support direct labor on the floor (fully trained in all hands-on tasks)

• Form and engage appropriate team required to execute the project and production, providing leadership and motivation

• Practices and promotes safe work habits and adheres to safety procedures and guidelines

• Ensure GMP Readiness operations and activities for equipment, processes, and personnel

• Define and establish clear objectives and expectations while developing employees and self

• Provide effective and constructive feedback to production staff and suggest corrective actions if needed to ensure production plans are fulfilled

Compliance

• Ability to aseptically gown and/or sterile gown as needed

• Manage the creation, implementation and compliance for all documentation, procedures and policies

• Perform batch record review, procedure revision/creation, and work order generation

• Proven understanding of applicable regulatory requirements

• Supports equipment, documentation, investigations, and improvement initiatives within manufacturing operations

• Maintain facility and room inspection readiness

What will convince us:

• Bachelor's Degree with 4+ years of industry related experience in cGMP manufacturing

• 1+ year(s) of supervisory experience, or the equivalent knowledge and experience.

• Knowledge of chemistry/engineering principles/biology/and manufacturing processes

• Experience with various aspects of GMP Manufacturing in Cleanrooms (Upstream, Downstream, Fill/Finish, Solution Prep)

• Experience in Project Management

• Experience working in aseptic environments

• Organizational skills - Ability to structure and plan the scope of work and set priorities for you and your team

• 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, 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

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class.

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

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 e-mail at [email protected]

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability, or based on status in any other protected group of class.

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 e-mail at [email protected]

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