Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsible for maintaining cGMPs for the HPV/ALUM Caspofungin API manufacturing facilities at MMD Elkton, in conformance with Merck policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. This will include responsibility for the release of manufactured products, including intermediates, APIs, sterile products, bulk vaccines, and potentially materials for clinical trials (as applicable).
He/She will be expected to maintain contemporary knowledge of cGMPs for all major markets as well as MMD Policies and Guidelines. Based on this he/she will provide quality support to the site, including training and guidance on the interpretation and implementation of MMD Guidelines/Policies and regulatory requirements. Responsible for a staff and adhering to approved budget. Qualifications: Education Minimum Requirement:
Required Experience and Skills:
- Bachelor's degree in science or engineering, BS w/ 5 years of relevant experience or an advanced degree preferred
Preferred Experience and Skills:
- Candidate should have worked previously in QA/Product Release or in Technical Operations. Candidate should have experience with regulatory inspections.
- Previous management experience.
- Candidate should have worked 5 years in QA/Product Release w/ experience? Preferred submitting CBER protocols or 5 years in Technical Operations? Preferred supporting manufacture of vaccines in classified (C space).
- Candidate should have experience with regulatory inspections (FDA and international). Experienced with Deviation Management, CAPA and Change Control Systems.
- Excellent communication and decision making skills.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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