Senior Director, CMC

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them. Essential Responsibilities ·       Provide strategic and managerial oversight of Chemistry, Manufacturing and Controls (CMC) operations including overseeing pharmaceutical laboratory method development, validation, and sample analysis in support of peptides, hormones and proteins (biomarker, cell-based, PK, immunogenicity, immuno-, and enzymatic assays), project management, and laboratory  material/instrument management ·       Manage CMC testing operations departments through a team of functional managers and front-line supervisors ·       Direct, develop, and provide leadership and technical mentoring to staff to establish operational procedures, solve operational problems, and develop technical protocols ·       Work with senior management on the planning and development of operational policies, objectives and initiatives ·       Provide client satisfaction, employee satisfaction, quality and on-time delivery of BioAgilytix services ·       Achieve corporate revenue targets ·       Align objectives and resources across all BioAgilytix teams and projects, in particular assuring that resources allocated to a given functional group match the workload priorities ·       Meet client’s expectations/timelines ·       Provide advice, directions and any required help with preparation and presentation of proposals to the clients ·       Monitor the production of regulatory documents generated within CMC Operations, in collaboration with Quality teams ·       Maintain contact with the Sales and Marketing team to achieve project objectives and establish realistic timelines Additional Responsibilities ·       Other duties as needed Minimum Acceptable Qualifications Education/Experience: ·       Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 14 years’ experience in a scientific laboratory environment; or ·       Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or ·       PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with no less than 10 years’ experience in a scientific laboratory environment Skills: ·       Ability to guide the development of immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen ·       Ability to work effectively within team to meet objectives under time constraints ·       Ability to take direction well and multi-task ·       Acute attention to detail and organizational skills ·       Excellent oral and written communication skills ·       Proficiency in MS Excel and Word ·       Demonstrated experience serving in a supervisor role and leading teams ·       Knowledge and application of regulatory guidance ·       Experience working in GMP environments and demonstrated knowledge of GMP regulations ·       Experience in leading cross functional teams, Laboratory operations, and product/project management in the pharmaceutical/biotechnology industry ·       Understanding of GMP regulations and knowledge of the FDA and EMEA guidelines and industry standards Supervisory Responsibility ·       This position supervises Director, Associate Director, Manager I/II, Scientist I/II/III, Analyst I/II/III, and other Operations staff. This position will directly supervise up to 8 employees, indirectly supervise up to 100 employees. Supervision Received ·       Infrequent supervision and instructions ·       Frequently exercises discretionary authority Working Environment ·       Primarily office environment ·       Occasional laboratory environment ·       Exposure to biological fluids with potential exposure to infectious organisms ·       Rare exposure to skin and lung irritants, toxic materials, and hazardous waste ·       Personal protective equipment required, such as protective eyewear, garments, and gloves ·       Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets Physical Demands ·       Ability to work in an upright and/or stationary position for up to 8 hours per day ·       Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment ·       Frequent mobility needed ·       Frequent crouching, stooping, with frequent bending and twisting of upper body and neck ·       Light to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 pounds ·       Ability to access and use a variety of computer software ·       Ability to communicate 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 to obtain or relate information to diverse groups ·       Requires multiple periods of intense concentration ·       Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence ·       Ability to perform under stress and multi-task ·       Regular and consistent attendance Position Type and Expected Hours of Work ·       This is a full-time position ·       Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook ·       Occasional weekend, holiday, and evening work required ·       Occasional travel required