Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
Ferring US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
Responsibilities:
The Associate, Process Excellence will demonstrate accountability for functional, technical, business, and broad company objectives. She / He is responsible for execution of projects tasks to support drug product technology transfer, continuous improvement, and regulatory compliance for the US Production site (Ferring Production, Inc.)
In this role She / He will integrate and develop processes that meet business needs across the organization, manage complex issues within functional areas of expertise and contribute to the execution of projects to meet agreed targets while ensuring regulatory compliance.
Lead selected technology transfer projects for the site (primarily for sterile manufacturing of drug products).
Execute proper design of experiment (DOE), process development, and process validation to ensure robustness and quality of drug products.
Coordinate regulatory submissions and author common technical documents for Chemistry, Manufacturing and Controls and associated modules.
Utilize project management tools and methodology to ensure proper schedule, budget, and cost.
Initiate, track and resolve Production/Packaging related non-conformance investigations. Assist area management in the investigation of the root causes, recommend corrective action(s).
Support the continuous improvement initiatives through the Lean Six Sigma (LSS) program at Ferring US.
Demonstrate a continuous improvement mindset and assist shop floor personnel with problem solving methodology with sound root cause analysis.
Contribute to the FPG improvement action plans, selection of the relevant projects and review of Key Process Indicators (KPI) to measure performance for the site.
Requirements:
Bachelor’s degree in science or engineering
At least 5+ years’ experience, within pharmaceutical industry and/or sterile manufacturing. Preferred experience within MTS/MSAT functions
Knowledge of cGMP for FDA (21 CFR 200s, 210s, 600s) and EMEA (Annex 1)
Relevant experience includes: pharmaceutical manufacturing support, process engineering, technology transfer of drug substance or drug product, and process qualification and validation.
Project management skills.
Demonstration of practical Lean/Six Sigma/QbD application and implementation; Yellow or Green Belt certification preferred.
Excellent communication and leadership skills with the ability to influence and work across organizational boundaries.
Action Oriented.
Balances stakeholders.
Collaborates.
Communicates effectively.
Tech Savvy.
Demonstrates self-awareness.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance.
Location:
Parsippany, New Jersey