By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.
This position is responsible for leading the overall validation, staffing and start up activities of the GMP Facility and the manufacturing and material management teams.
- Manages Team that is responsible for
- Setting and following the production schedule
- Preparing equipment by performing sterile cleaning-in-place (CIP), steam-in-place (SIP), and cleaning out-of-place (COP); conducting operator inspections; performing preventive maintenance checks etc.
- Adhering to fermentation, purification, aseptic filtering, filling and lyophilization procedures.
- Maintaining safe, compliant and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
- Keeping equipment functional by following operating instructions, troubleshooting breakdowns, and calling for repairs.
- Documenting production by completing forms, reports, logs, and records of equipment and batches
- Inventory control and raw material receiving
- Manage personnel, projects and schedules to perform and complete specific projects according to goals and initiatives.
- Address employee issues and serve as a role model in professional behavior.
- Follows company policies and practices as outlined in Handbook and follow guidelines regarding safety as outline in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.
- Perform additional duties as assigned.
Education and Experience:
- Bachelor’s Degree in Biochemistry or equivalent
- 10 years of Manufacturing and Leadership experience.
- Experience working in a regulated environment is required.
- MBA preferred.
- Knowledge, Skills and Abilities:
- Ability to present the site and its capabilities to key customers during site visits and quality audits
- Ability to develop an organization from a small startup operation to a large scale manufacturing facility.
- Ability to make effective decisions and execute an appropriate course of action considering all relevant variables.
- Ability to provide leadership by establishing, articulating and modeling the vision and goals; ability to guide others in a direction that aligns with same vision and goal.
- Knowledge of protein purification, protein refolding, and protein structure.
- Skill in establishing effective interpersonal relationships such as the ability to solicit key ideas and information.
- Skills in problem solving and critical thinking, including the ability to identify and appropriately evaluate an alternative course of action.
- Skills in planning, organizational, time management and multi-tasking.
- Ability to negotiate by collaborating with others to arrive at a conclusion using compromise, persuasion, and diplomacy.
- Excellent verbal and written communication skills including technical writing and presentation skills.
- Knowledge of safety and company rules and policies.
- Ability to handle sensitive and proprietary information with discretion and confidentiality.