Senior Director, CMC - Durham, NC

+ Job summary 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 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
+ 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 + Responsibilities Provide strategic managerial oversight of Chemistry Manufacturing Controls CMC operations including overseeing pharmaceutical laboratory method development validation sample analysis project management chemistry manufacturing controls testing operations laboratories material instrumentation management manage CMC testing operation departments functional managers front-line supervisors direct develop lead technical mentoring staff establish operational procedures solve operational problems develop technical protocols Work senior management planning development operational policies objectives initiatives provide client satisfaction employee satisfaction quality delivery BioAgilytix services achieve corporate revenue targets align objectives resources BioAgilytix teams projects assure resources allocated given functional group match workload priorities meet client expectations timelines provide advice directions required help preparation presentation proposals clients monitor production regulatory documents generated CMC Operations collaboration Quality teams maintain contact Sales Marketing team achieve project objectives realistic timelines Other duties as needed + Skills Ability guide immunoassays some following immunoassay platforms ELISA MSD-ECL RIA DELFIA HTRF AlphaScreen ability work effectively team meet objectives time constraints take direction well multi-task acute attention detail organizational skills excellent oral written communication skills proficiency MS Excel Word demonstrated experience supervisor role leading teams knowledge application regulatory guidance GMP environments demonstrated knowledge GMP regulations cross-functional teams Laboratory product-project-management pharmaceutical/biotechnol industry understanding GMP regulations knowledge FDA EMEA guidelines industry standards Supervision Received Infrequent supervision instructions frequently exercises discretionary authority Working Environment Primarily office environment Occasional laboratory exposure biological fluids potential infectious organisms rare exposure skin lung irritants toxic materials hazardous waste personal protective equipment required protective eyewear garments gloves Routine uses standard office equipment computers phones photocopiers filing cabinets Physical Demands Ability work upright stationary position hours per day repetitive hand movement both hands ability make fast simple repeated movements fingers hands wrists operate lab equipment frequent mobility needed crouching stooping bending twisting upper body neck light moderate lifting carrying objects including lab equipment supplies laptop computer max lift pounds ability access use various software communicate information ideas others understand listen understand information ideas presented spoken words sentences frequently interacts diverse groups multiple periods intense concentration wide range variable tasks dictated demands changing conditions predictability requires perform stress multitask regular consistent attendance Position Type Expected Hours Work full-time position flexibility hours allowed must available core work hours published BioAgilytix Employee Handbook occasional weekend holiday evening work required occasional travel benefits perks Medical Insurance HDHP HSA PPO Dental Insurance Vision Insurance Flexible Spending Account medical dependent care Short Term Disability Long Term Disability Life Insurance Paid Time Off weeks per year Parental Leave Paid Holidays scheduled floating Employer Match Employee Referral Program COMMITMENT EQUAL OPPORTUNITY

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