Supervisor, Downstream Purification
Key Responsibilities
Leadership Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight.
Accomplishes tasks through direct and effective coordination.
Provides direction and hands-on training for staff.
Manages staff.
Lives department values and sets the standards for others to operate.
Fosters an environment of compliance, strong work ethic and ongoing learning.
Contribution
Ability to take responsibility for complex projects
Effective interaction with peers across manufacturing to create alignment and improvement
Partners with support groups (Facilities, Validation, MSAT, Quality) to complete scheduled activities
Process Knowledge
Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance.
Ability to troubleshoot, identify issues and support resolutions with technical groups
Technical Competency
Required to perform ongoing operational tasks in respective work area.
Uses scientific thinking and decision making in daily work
Technical Documentation: Provide feedback and/or suggested changes to operational procedures
Assist in the incorporation of new technologies, practices and standards into procedures
Capable of writing and reviewing process documents
Quality and Compliance
Complete understanding and adherence to cGMP’s as related to commercial operations.
Initiate and own required Corrective and Preventative actions and lead change control actions
Support the closure of manufacturing discrepancies and change requests
Current understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products
Business Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, )
Support trending and communication of defined department metrics
Identify and drive opportunities for process & business optimization
Translates company and department goals into actionable objectives for self and staff
NIGHT SHIFT DETAILS
Sun-Tues, alt Wed, 1800-0700
MFG area is specific to Drug Substance Purification
100% time on-site
We do provide Shift Differential pay for any off-hour shifts including Swing and Grave
EDUCATION
B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
Experience 4+ years of directly related industry experience, including at least 2+ years with proven leadership role
Ability to independently manage work, actions and expectations is essential
PLEASE NOTE
Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.