Project Manager, Quality Control

Rensselaer, New York, US
Aug 12, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Manage timelines, lead projects and monitor laboratory performance within the Quality Control department.

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

• Leads cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints.

• Develop and maintain forecasting tools for QC testing and projects; translating the forecast into measurable goals for the laboratories. Provides guidance to QC Management in assessing resource, equipment and space needs.

• Develops tools and mechanisms for monitoring QC laboratory performance and problem solving; such as turnaround time, conformance to schedule, invalid rates, equipment usage.

• Proactively identifies issues and provides general guidance to resolve QC operational issues and works with laboratory management to develop solutions to meet productivity/quality objectives.

• Monitor and coordinate the QC activities required for submission of license applications, INDs, and other regulatory documents to government agencies.

• Monitor the departmental performance for NOE/EOE/DNF/CAPA/WF; track, assist and organize continuous improvement events.

• Regularly interacts with Sr. Management or executive levels. Exercises judgment and exerts some influence on the overall objectives and long-range goals of the QC Department. Represents the department in relevant internal/external committees.

• Serve as a primary point of contact among functional areas for QC-related issues. Works with the supervisor/Department Director to identify and resolve any team and individual performance issues.

• Lead special projects as assigned by supervisor/department management.

Knowledge, Skills & Abilities:

• Ability to maintain integrity and honesty at all times.

• Ability to work independently or as part of a team.

• Ability to communicate with transparency.

• Continuously drive to improve processes for improved performance.

• Demonstrate respectful behavior at all times.

• Accountable for the performance and results of a technical initiative.

• Accountable for resource planning with a focus on technical skill and capabilities.

• Shapes the future direction of technology at IOPS.

• Seeks out and leads critical projects that benefit the business.

• Business continuity and long-term planning.

• Ability to influence outside of own department and external to company.

• Create departmental goals and assign resources based on business needs.

• Lead by example; be a team player.

• Lead with transparency.

• Diagnose status of organization and positively impact culture.

• Evolving knowledge of global organization and industry trends.
Education and Experience:

• BA/BS in chemistry, biology or related field with a minimum of 10 years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Project Management experience and/or PMP certification is considered a plus.

• Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company. Resolves and negotiates conflicts or problems with tact, diplomacy and composure. Ability to handle multiple projects and priorities with exceptional organizational and time management skills.

*Level will be determined based upon experience*

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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.