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Lead Formulation Specialist
2 months ago
About Simtra BioPharma Solutions:
For over 65 years, pharmaceutical and biotech companies have collaborated with Simtra BioPharma Solutions to successfully launch their sterile injectable products.
Simtra stands as a premier Contract Development Manufacturing Organization, boasting state-of-the-art facilities. We provide a diverse array of delivery systems, including prefilled syringes, liquid and lyophilized vials, and sterile crystallization.
Our Expertise:
Our product portfolio encompasses biologics, small molecules, cytotoxics, highly potent compounds, and vaccines, all of which are crucial for patient care globally. At Simtra, we prioritize quality and continuous enhancement, adhering to the highest quality and regulatory standards.
Role Overview:
The Lead Formulation Specialist is an integral member of the Manufacturing Leadership Team, directly reporting to the Manufacturing Supervisor. This role is pivotal in supporting manufacturing operations to ensure that the final products align with the required specifications.
Key Responsibilities:
1. Coordinate activities of Formulation Operators in the manufacturing areas.
2. Provide oversight to ensure compliance with regulatory agency regulations and Simtra Standard Operating Procedures.
3. Foster a culture of quality operations on the production floor, ensuring effective communication with team members and management.
Team Environment:
Create a workplace where teamwork, productivity, safety, and quality are paramount in the finished product.
Work Schedule:
This is a full-time position with a unique shift structure, requiring flexibility and commitment to scheduled plant holidays.
Essential Duties:
- Prepare media and buffer solutions.
- Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.
- Utilize general production equipment and monitor critical process parameters.
- Complete documentation in accordance with GDP/GMP guidelines.
Qualifications:
To excel in this role, candidates should possess:
- A high school diploma or GED.
- Previous experience in Pharmaceutical or Manufacturing environments is preferred.
- Strong communication and documentation skills.
Physical Requirements:
Ability to perform various physical tasks, including lifting and operating controls, while adhering to safety protocols in a classified pharmaceutical environment.
Equal Opportunity:
Simtra is committed to fostering an inclusive workplace and evaluates qualified applicants without regard to any legally protected characteristics.
