Associate Manager Filling Suite Process Maintenance

Location
Rensselaer, NY, United States
Posted
Jul 17, 2019
Ref
17161BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: The major responsibilities of the Filling Suite Manager position will be to manage the all associated maintenance resources and all maintenance activities related to the operation of the Rensselaer site Filling and Pack/Label operations. These responsibilities include maintaining all areas so that they will comply with all company policies, SOPs, cGMP and OSHA requirements.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Manage and develop the aseptic filling process maintenance team to meet and exceed expectation and all time-lines.

• Develop short and long term strategic planning improvements and oversee those improvements.

• Ensure compliance with state, FDA, OSHA, cGMP or other applicable regulations.

• Work collaboratively with Manufacturing, Quality Assurance / Validation, Engineering, Automation and Quality Control personnel to accomplish department performance objectives.

• Insure the highest level of customer service for both internal and external customers is maintained always.

• Oversee and participate in the recruitment and selection and successful onboarding of department staff.

• Provide direct reports with ongoing performance feedback and develop a positive work environment for all employees.

• Ensure that employee training and competency is always up to date to ensure that all related requirements are maintained with in prescribed technical and safety standards.

• Define and ensure adherence to departmental budget.

• Comply with company policies, SOPs, cGMP and OSHA requirements.

• Participate in deviation and root cause investigations as required.

• When needed be able to assist with troubleshooting and repairs on filling and packaging equipment and process critical utility equipment and systems.

• Promote good relationships within the department and with other departments within the company site

• Responsible for managing investigations, coordinating study teams and completing investigation documentation

• Maintain area of responsibility and other areas at highest level of compliance at all times

• Perform and manage other duties and projects as required

Education and Experience:

• Requires A.S. in engineering, science or related field with 6+ years of experience in a similar position or equivalent combination of education and experience. Will substitute equivalent years of direct experience for education.

• 5 plus years of supervision experience in planning, organizing, and direction of a diverse workforce involved pharmaceutical production operations for aseptic formulations, filling and lyophilization.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.