Vice President of Manufacturing -Rapid Growth!

Vice President Manufacturing- Rapid Growth Product Portfolio!Sioux Falls, SDOur client, a specialty pharmaceutical company is searching for an experienced candidate with first hand or relevant experience in the successful implementation of new product lines.  This senior manager will report directly to the President and, working with the senior management team, participate in the selection and prioritization of product candidates, the preparation and submission of regulatory documents, and primary responsibility for the selection and continuous oversight of contracted manufacturers.  Essential Duties & Responsibilities · Evaluate and adjust the manufacturing processes and the pool of contract manufacturers· Coordinate the authoring of the chemistry and manufacturing controls or CMC· Negotiate in concert with legal advisors manufacturing contracts for pharmaceutical products· Maintain continuous oversight of contracted product manufacturers · Conduct periodic process review for improving quality and cost measures· Maintain good working relationships with regulatory authorities having cGMP oversight including the U.S. FDA, the U.S.D.A, the European Medicines Agency and the Japanese Ministry of Health and Welfare.· Visit and inspect contracted manufacturers as and when needed to maintain proper oversight and regulatory compliance for the pharmaceutical products.Requirements· Ph.D. or MD in disciplines such as Pharmaceutical Science, Chemistry, and Biology· Masters Degree in Regulatory Affairs is highly preferred· 10+ years relevant experience in pharmaceutical small molecule product development Senior-level management of an approved new drug from development stages to market launch· Strong practical and executable knowledge of 505(b)(2) and NCE regulatory affairs· Strong practical knowledge of CNS and the regulatory affairs issues is preferred· Strong working knowledge of regulatory procedures and proven success in leading the coordination and preparation of document packages for regulatory submissions from all disciplines within the Company· Extensive knowledge and background working with the FDA and other regulatory agencies· Effective communication skills in English language (writing, speaking, comprehending) Knowledge of Microsoft Office package including Word, Outlook, Excel, Project Commitment to the success of the business· Ability to work independently and as part of a team· Must be innovative, dynamic with ethical standards of integrity and quality, and caring attitude· Capable of performing other duties as assigned· Authorized to legally work in the United States without Visa sponsorshipIMPORTANT: Initially, you do not need to send me your resume, disclose your name or the company you work for. All you need to do is call me at 888.693.6887 ext. 221. I understand confidentiality is “critical” in relation to this opportunity as it’s more important for me to find the perfect match than to “initially” know your name. Communication in Confidence….888.693.6887 Ext. 221  Compensation: Compensation for this position ranges from $125k to $175K with bonuses ranging from 10-30% of base salary plus profit sharing and matching 401K. Benefits $125k-$175K base salary Generous vacation package and sick leave Production Bonus Very flexible and family friendly hours Generous Matching 401K plansAbout Us: MR of Sioux Falls, LLP is a full service staffing company that will assist you with both professional permanent placement as well as interim placement. Our 16+ years of service and reputation have allowed us to become recognized as a LEADER within the world’s largest network of executive search professionals, comprised of over 1,000 offices and 3,500 professional recruiters, by achieving the International #1 TEAM for last two consecutive years. We are looking for outstanding Healthcare professionals who pride themselves on their integrity, reputation and work history as “THE top performers” in their respected industries.  We work with these top caliber professionals to confidentially prospect and pursue their next outstanding opportunity in their career.For more information about our company please visit our website at www.agoodjob.com MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-SD-East/Sioux Falls JOB CATEGORY: Manufacturing/Production/Operations TYPE: Employee SALARY: 125,000.00 - 175,000.00 /year JOB REFCODE: AEC 0321-7 COMPANY: Management Recruiters of Sioux Falls CONTACT NAME: Andrew Cornett ADDRESS: 116 W 69th StreetSuite 200Sioux Falls,SD 57108 EMAIL: Apply by Email