Director of Operations, Bio Supplies Manufacturing

include but are not limited to: Oversee the establishment and implementation of manufacturing and quality policies to assure the compliance with the FDA and/or EC, if applicable. And other applicable regulations guidelines and practices related with the manufacture of the Bio Supplies products Oversee and ensure that each product has been manufactured and/or tested in accordance with the

of its license (or marketing authorization) and the principles and guidelines of the current regulations Establish Bio Supplies manufacturing site goals and objectives; track and evaluate the critical process data to recommend continuous improvement throughout the organization. Propose and Manage the budgets and investments of Bio Supplies Manufacturing site departments and facilities in order to assure the correct performance of the work in these areas and the implementation of improvements in these areas in light of technical, scientific progress and advancements. Lead staff meetings to update and direct senior management in regards to business issues occurring in the organization. Responsible to communicate Manufacturing Operations strategy to Top Management and lead Management meetings accordingly Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility. Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training. Directly supervises the Manufacturing site Operations Management team Available to travel as needed Participates with senior management to establish strategic plans and objectives. Makes final decisions on implementation and ensures operational effectiveness. Effectively cascades functional strategy and contributes to development of organizational policies. Interacts with senior management and executives on decisions that affect business operations. Reconciles Bio Supplies leadership views to drive business results. This Job Description is intended to present the general content and

for the performance of this position. The description should not be construed as an exhaustive statement of duties,

as needed. Skills/Qualifications/Education: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The

listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Master’s Degree in Biology, Chemistry, Biochemistry, Engineering or closely related scientific/technical discipline. An equivalent combination of education and experience may be taken into consideration Minimum 10 years senior management experience, preferably in an FDA regulated environment; Project Management experience required Thorough knowledge of FDA and international regulatory, quality and cGMP regulations Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates Excellent verbal and written communication Must be able to read, write, and speak English Must have strong technical writing skills Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner Ability to manage multiple projects, simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment Strong organizational, analytical and problem-solving skills Ability to analyze detail and perform structured decision-making daily Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations, frequently travels within the United States, occasional international travel. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occur