Overview:
We are LOTTE Biologics! A new company, built on 80 years of tradition!
We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
We deliver therapies that make a Healthier World!
Responsibilities:
To help us meet our mission LOTTE BIOLOGICS is in need of a Senior Manager who will be responsible for Antibody Drug Conjugate (ADC) Quality Control laboratory operations to include microbiological and analytical testing activities that support the onsite (ADC) manufacturing facility. This position will also support development of the facility and laboratory design, equipment and instrument validation, and method development, development of SOPs and technical transfer activities. The Senior Manager is accountable for ensuring a safe, quality driven, efficient, and robust culture while continuously challenging inefficiency at every opportunity.
Duties/Responsibilities:
- Support the design and commissioning of the LOTTE-Syracuse ADC QC laboratories.
- Recruit, lead, and develop high quality team members with diverse backgrounds and talent capable of delivering against established goals and objectives.
- Oversee the daily operation of the Quality Control laboratory testing and result reporting of raw materials, utilities, in process, and final bulk product samples to support the manufacturing of bulk drug substance.
- Lead a health and safety culture to maintain a safe working environment in the laboratory.
- Provide technical and operational expertise for the training and development of staff, assistance in troubleshooting, and conducting investigations for out of specification results.
- Support method development and manage qualification, and technical transfer of new Antibody Drug Conjugate analytical and microbiological test methods
- Provide microbiological and analytical technical expertise in support of manufacturing and development initiatives.
- Accountable for adherence to schedules for sample analysis to support the manufacture of drug substance and on time release of final bulk drug substance.
- Create an environment of continuous learning, improvement, and innovation and coach the team in execution against strategy.
- Accountable for adherence to SOPs, cGMPs, FDA, OSHA, ICH, and other regulatory agency requirements.
- Accountable for compliance with applicable Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
- Ensures all personnel have adequate training, education, and experience to perform their GMP related job function effectively.
- Serve as Subject Matter Expert and participate in the site team supporting regulatory inspections and audits.
Supervisory Responsibilities:
- Will supervise a staff of approximately ~7 employees.
- Oversee work including lead, train and direct work of others to meet company and department objectives.
- Provides coaching, feedback, training and performance evaluations.
- Develop and grow staff technically and professionally by directing development efforts towards excellence and higher degree of proficiency.
Remote Position:falseMin Compensation :USD $91,000.00/Yr.Max Compensation :USD $142,000.00/Yr.Bonus:16%Qualifications:
Education/Experience/ Licenses/Certifications:
- Knowledge of science generally attained through studies resulting in a B.S. in physical or life sciences (e.g. microbiology, biochemistry, molecular biology, or related discipline) or its equivalent.
- Minimum of 8 years experience in a cGMP environment with previous management of personnel preferred.
- Experience building and growing an organization into a high-performance team and influencing in a matrix environment.
- Proven experience in FDA (or other regulatory authority) inspection preparation and management.
Specific Knowledge, Skills, Abilities, etc:
- Demonstrated leadership, interpersonal, communication motivational and problem-solving skills.
- Knowledge of biopharmaceutical manufacturing and microbiological and analytical testing is highly desirable.
- Analytical ADC experience desired.
- Extensive knowledge of regulatory requirements (e.g. US, EMA, Compendia) and industry best practices.
- Knowledge of applicable business systems including (e.g. SAP, Maximo, Electronic notebooks)
Physical Demands:
This is both an office and laboratory-based position that may require repetitive use of arms, hands and wrists, especially when working with computers. Depending on work demands, office-based work requires sitting.
Work Environment:
This position is an office-based role with occasional exposure to laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents.
Travel:
This position requires up to