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Senior Associate Production Scientist
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Senior Associate Production Scientist position, located in St. Louis, MO, USA, supports our cGMP Manufacturing in the areas of protein purification and bioconjugation, specifically Antibody Drug Conjugates (ADCs). ADCs are an exciting class of biopharmaceutical drugs that utilize both the targeting effects of monoclonal antibodies and the potent activity of cytotoxic drugs, hence allowing discrimination between the cancer cells and healthy normal cells. In this role, you will apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice.
The Senior Associate Production Scientists may serve as the technical manufacturing or support lead on pilot scale and full-scale manufacturing of new APIs. Responsibilities may include assisting in writing the scale-up cGMP batch records, coordinating and delegating all tasks and responsibilities associated with GMP Manufacturing. The manufacturing of APIs requires ISO 7/8 clean rooms. May occasionally wear PPE when working in classified rooms. Certain APIs are considered high potent compounds. When handling these materials, this employee may occasionally wear additional PPE. Sr. Associate Production Scientists may occasionally work in the presence of the customer, with high value, customer-owned, raw materials and, therefore, show confidence and composure when working with both potent and non-potent API’s.
In this role you will be leading and supporting a small manufacturing team in the scale-up, technology transfer, and execution of ‘on the floor’ cGMP manufacturing. The Sr. Associate Production Scientist provides technical guidance to associate production scientists and operators and will be working with the Senior Production Scientists to ensure successful manufacturing of custom biopharmaceutical APIs. In this role, you’ll be interacting cross-functionally with Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering and Maintenance. This role may also utilize some level of interaction with our customers’ project management, technical and quality teams. The employee may occasionally have direct interaction with Process Development, Quality Assurance, Quality Control, Project Management and customers. Occasional lifting and pushing heavy vessels/equipment.
Who You Are:
- Bachelor of Science in Life Science or Biology, Chemistry or Chemical Engineering or related Scientific discipline
- 3+ years of experience working in a cGMP API manufacturing experience
- Master of Science in Life Science or Chemical Engineering or related discipline
- Prior experience working in a manufacturing environment
- Good computer skills using Microsoft Office based programs
- Familiarity with analytical instrumentation and cGMP process equipment
- Experience with customer interaction
- Communication skills, both oral and written
- This position requires a strong technical and quality background.
- Ability to identify safety, quality and compliance risks
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.