The Senior Biochemist, Beads Manufacturing must have extensive working experience and in-depth knowledge in the Beads Manufacturing processes. This role demands strong problem-solving and troubleshooting abilities.  Additionally, they are responsible for training team members in troubleshooting techniques and effectively communicating with the team to minimize business disruptions when issues arise.  The Senior Biochemist requires the ability to schedule and effectively train other Biochemists on the Beads conjugation processes along with SOP/WI. The role is responsible for accurately and promptly verifying new product data.  Additionally, the position may involve reviewing production cost variances and managing TECO production orders to help minimize production variances.  This role should have a comprehensive understanding of the Beads Manufacturing department to meet overall productivity goals and regularly identify areas for improvement and updating the SOP/WI for lab operations. The position will also support and participate in continuous improvement projects as identified by the leadership team and assigned by the Senior Manager.

Accountabilities: 

• Be a role model and set a good example involving current department policies and procedures.

• Have a firm understanding of all SOP’s and batch recordsandcaneffectivelycommunicateto junioror departmentalpersonnel.

• Follow all departmental guidelines and procedures

• Be capable to take the challenging assignments

• Be capable to train otherBiochemistsor otherpersonnelproperly and effectively

• Other duties as assigned bythe SeniorManager

RESPONSIBILITIES: 

• Overall expectations set within job as setting the example within the group indemonstrating:

• Work well independently, responsible for project development, complete knowledge of technical skills to serve as core reference for problem solvinginternallyand review training.

• Consistency in technique, documentation, data entry, labeling, aliquot of QC samples, equipment operation, meeting production specifications with assignments, and committing to due dates.

• Understanding background and critical points to chemistry involved in makingbead manufacturing.

• Promote a safe working environment.

• Learn, follow, and set as an example for all-new and current policies and procedures per company, department, and group.

• Be able to perform all the existingBeadsManufacturingaccurately and independently, having a complete understanding of the techniques, theories and background involved.

• Maintain attendance, reliability, teamwork, and product quality

• Have effective communication skills within and outside the departmentregardingassignments.

• Be able to provide process training properlyso team members have a clear understanding ofexpected yield and product quality.

• Proficient intheBeadsManufacturingprocessesin production. Be able toinitiatequality notifications, ECRs, and review and input manufacturing specifications and perform data verification for new product transfer withaccurateinformationina regular basis.

• Review final assignments to help control product quality, avoidingproblematic product being sent out.

• Review and address issues during batch record or other document review tomeetallquality requirements. 

Education and Experience:

Education:

• BS Degree required - Life Sciences or related field

• MS degree– Life Sciences or related field a plus

Work Experience: 

• Requires aminimum of6yearswithBS Degree or minimumof5yearswith aMS Degree experience in a Biotech/Science manufacturing lab environment

• Have thorough working knowledge in the science disciplines, labequipmentand work independently with abilities to supervise and train all other departmental employees. 

Knowledge and Skills:

• Demonstrated ability to use laboratory instruments and applicable computersoftware.

• Knowledge of general laboratory safety.

• Effective interpersonal skills.

• Effective written and oral communication skills.

• Demonstrated ability to follow established policies and procedures.

• Demonstrated ability to keep neat,accurate, and complete records and logs.

• Effective analytical problem-solvingskillsand troubleshooting skills.

• Bead and/or protein conjugationpreferred

• Bead Countingpreferred 

• Bead product dispersion/suspensionpreferred

• Optical Density measurementpreferred

• Chromatographypreferred

• Operation ofFlow Cytometers preferred, including LSR II, Canto II, Lyrics, Discovery, Symphony, Calibur

Physical Demands:

• General physical requirements:Laboratorywork

• Visual acuity requirements: Inspection / Administrative.

• Motion and sensory requirements: Talking, hearing, and walking.

• Primary functions require sufficient physical ability and mobility to work in a lab setting; to stand or sit for prolonged periods of time; to occasionally stoop, bend, kneel, crouch, reach, and twist; to reach, lift and carry glassware with or without hazard chemicals up to 10 pounds; to push and pull carts with load up to 250 pounds.