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 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 the role of Production Scientist, you will lead and support a small manufacturing team in the scale-up, technology transfer, and execution of ‘on the floor’ cGMP manufacturing. The Production Scientist serves as technical leader and will work 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 occasionally interact with our customers’ project management, technical and quality teams.
The Production Scientist will have “hands on” experience in a cGMP Biologics manufacturing environment. Drive and initiative to grow into a strong leader within Manufacturing Operations. As a custom API contract manufacturing organization, our Production Scientists will have technical and communication skills.
The Production Scientist may serve as the technical manufacturing or support lead on pilot scale and full-scale manufacturing of new APIs.
- Assist in writing the scale-up cGMP batch record
- Coordinating and delegating all tasks and responsibilities associated with GMP Manufacturing operations
- Communicating the status of operations to leadership and the customer
- This employee will use Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports. Production Scientists will work in the presence of the customer, with high value, customer-owned, raw materials.
- This position may utilize shift hours during Manufacturing Campaigns.
- Lift up to 50 lbs and pushing heavy vessels/equipment.
- Must wear Personnel Protective Equipment (PPE) when working in classified rooms.
- Certain APIs are considered high potent compounds so when handling these materials, you must wear additional PPE.
- The manufacturing of APIs will occur in classified clean rooms.
Who You Are:
- Bachelor of Science Degree in Chemical Engineering or related Life Science discipline and 3+ years working in a cGMP API manufacturing environment
- Master of Science Degree in Chemical Engineering or related Life Science discipline and 1+ years working in a manufacturing or laboratory environment
- Experience using Microsoft Office programs
- Knowledge in chemistry, biology, biochemistry, and math, as well as an understanding of current Good Manufacturing Practices
- Excellent communication skill, both written and oral
- Apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice
- Ability to identify potential safety, quality and compliance risks associated with technology transfer and scale-up and propose solutions to mitigate risk prior to GMP Manufacturing operations.
- Familiarity with analytical instrumentation and cGMP process equipment
- Experience with customer interaction
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.