LOCATION: Germantown, Maryland
Responsible for the day-to-day supervision of Molecular Biology and Vialing and Assembly personnel. Ensures that relevant regulations (including QSR, ISO, OSHA, IVDD, MDD) are met and the production schedule is satisfactorily attained. Analyzes work processes to ensure that staff capacity and equipment utilization are maximized. Responsible for managing documentation, departmental validation, process improvement, development and product-transfer activities. Able to effectively collaborate with peers to obtain favorable results.
***This position is on 2nd shift. The hours will be 3:00pm-11:00pm.***
MAIN TASKS (PRIMARY RESPONSIBILITIES) OF THE POSITION:
Manager Manufacturing Responsibilities:
Include the following but other duties may be assigned:
Manage, mentor and foster the technical progression and professional development of the Supervisors, Scientists and Technicians of the area of responsibility
Ensure that laboratories are maintained in accordance with regulations and the production schedule is consistently met in a timely manner with high-quality results
Ensure that Manufacturing operational capacity is maintained to meet the production forecast
Ensure that personnel are adequately trained and effectively utilized to perform their job functions safely, efficiently and according to documented procedures
Responsible for daily oversight of technical batch record review and data analysis and financial shop order variance review, assuring standard product costs are maintained
Manage troubleshooting activities as needed by independently designing experiments and analyzing data
Review and write production MMRs and SOPs
Manage investigations for manufacturing product/process nonconformities
Carry out validations and implement cost-reduction, process efficiency and / or product quality improvements.
Participate in the product-transfer process
Report team metrics and performance measurements
Direct supervision of Manufacturing Supervisors, Scientists and Technicians
Must have a B.S./B.A. degree with at least 8 years of molecular biology or related field , including at least two years prior supervisory experience in a laboratory environment.
Masters degree and previous GMP production experience preferred.
Technical proficiency in molecular biology or related field and previous experience in a biotechnology manufacturing environment
Data analysis competency
Strong leadership and organizational skills
Knowledge of current QSR, ISO, OSHA, IVDD, MDD regulations desirable
Proficiency with basic laboratory equipment operation
Proficiency with MS WORD, EXCEL, ACCESS and POWERPOINT
Command of spoken and written English is required.
Must be articulate and able to communicate effectively with employees at all levels of the organization.
Must be able to write and review complex technical documents.
Excellent mathematical skills are required
Must be able to exercise sound technical and business decision-making responsibilities in a multi-tasking environment
The work environment is fast-paced and involves the ability to quickly change priorities and multi-task while maintaining a professional demeanor. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
To apply: https://www.linkedin.com/jobs/view/1816222399/